Food and Drug Law

The [In]adequate Provision Loophole: The Future of Drug Advertisements

November 10, 2025
Administrative Law, Food and Drug Law, Telecommunication

Caelen Caspers, MJLST Staffer

The television shows a sunny day, birds chirping, and kids skipping. A journal staffer attempts to join in, but winces in remembrance of cite checks. The narrator sighs and explains that life’s moments should not be interrupted by the discomfort of bluebooking. Loudly, the narrator cuts in, “That’s why there’s LawRizzy—clinically proven to relieve the racking pain of cite checks.” The narrator directs you to talk to your healthcare provider and rambles off a few side effects.

Sound familiar? Direct-to-consumer (“DTC”) drug broadcasts have become prolific on our television, social media, podcasts, etc. The rise of DTC advertising is attributed mainly to the “adequate provision loophole”[1]—a regulatory text utilized by drug companies to minimize risk disclosures and instead refer viewers to a secondary source for additional information.[2]

On September 9, 2025, the Food and Drug Administration (“FDA”) announced plans to rescind the loophole.[3] Without it, pharmaceutical companies would have to provide a disclosure of all necessary information related to a drug’s side effects and contraindications in their advertisements.[4] Controversy has since ensued.

 

Statutory Context

Currently, the law requires that broadcast advertisements must include a “major statement” of “information relating to major side effects and contraindications . . . of the advertised drugs.”[5] Additionally, the advertisements must contain a “brief summary of all necessary information related to [the major statement], unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation.”[6]

The provision did not garner loophole status until 1997, following guidance by the FDA,[7] wherein a drug company provides an adequate provision by presenting “reasonably convenient access” to the product’s labeling.[8] This can be accomplished by disclosing a toll-free number, print page, webpage, and a directive to speak to a medical professional.[9] Lucy Rose, a former FDA employee involved in drafting the guidance, explained that the purpose of the is regulation not as a loophole, but rather to balance “the demands for marketing new drugs and informing patients.”[10]

 

The Controversy

Indeed, there are many persuasive arguments in favor of the adequate provision loophole. First, proponents argue that it is essential to avoid burdening the consumer with bulky risk information.[11] The mass of information merely functions to fearmonger, desensitize, and dilute more serious risks among minor issues.[12] Second, proponents underscore the benefits to public health, such as public awareness and market competition.[13] Moreover, standards for disclosure and fair balance are well-established, hence, if the administration were to enforce the existing law, then there would be no need for eliminating the provision.[14] Finally, proponents warn that the FDA’s proposed action will have a chilling effect on drug companies’ First Amendment rights.[15]

Those adverse to the provision argue that it is “used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.”[16] The FDA contends that DTC ads lead to more prescription requests and inappropriate prescribing.[17] FDA Commissioner, Marty Makary, stressed that the 25% of drug companies’ budget towards advertising could be “better spent on lowering drug prices for everyday Americans.”[18] Furthermore, the FDA admitted to difficulty in regulating DTC advertising in social media, making it “increasingly difficult for patients to distinguish between evidence-based information and promotional material.”[19]

 

The Future

It is easy to envision the provision in practice, given the unavoidability of DTC advertisements on our screens. You anticipate the statement “ask your health provider about LawRizzy! Side effects include panic attacks, failing journal, or dizziness.” Without it, advertisers would be required to include a “brief summary of all necessary information related to the major side effects and contraindications.”[20]

But what constitutes a brief summary? Health and Human Services (“HHS”) Secretary Robert F. Kennedy proclaimed “[o]nly radical transparency will break the cycle of over-medicalization that drives America’s chronic disease epidemic.”[21] Thus, on one extreme, it appears that the purpose of the rescission is part of a larger effort to ban DTC drug advertisements altogether.

Is it realistic that the FDA can curtail all drug advertisements? Before to 1997, drug advertising in the United States was virtually non-existent.[22] However, given that DTC ads have become industry standard, it might be too difficult to put the mouse back in the bag. And, Big Pharma is unlikely to go quietly, likely to give rise to immense litigation.[23]

The FDA has yet to release guidance on what constitutes presentation of a “brief summary.”[24] One might expect subsequent guidance from the FDA, as done prior with “major statement” in 2023[25] and “adequate provision” in 1999.[26] Until it does, the future landscape of DTC drug advertising will remain uncertain.

 

Notes

[1] U.S. Dep’t Health & Hum. Servs., HHS, FDA to Require Full Safety Disclosure in Drug Ads (Sept. 9, 2025), https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency.html.

[2] See Login H. Merril, The FDA Just Killed Big Pharma’s Favorite Loophole, Freedom (Sept. 20, 2025), https://www.freedommag.org/news/the-fda-just-killed-big-pharmas-favorite-loophole-d87bf6 (explaining the adequate provision).

[3] U.S. Food & Drug Admin., FDA Launches Crackdown on Deceptive Drug Advertising (Sept. 9, 2025), https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising.

[4] Id.

[5] 21 C.F.R. 202.1(e)(1)(i)(A).

[6] 21 C.F.R. 202.1(e)(1)(i)(B) (emphasis added).

[7] U.S. Food & Drug Admin., Guidance for Industry: Consumer Directed Broadcast Advertisements 2–3 (Aug. 1999), https://www.fda.gov/media/75406/download.

[8] Id. x

[9] Id.

[10] See Annalee Armstrong, In New DTC Ad Crackdown, FDA Trying to Close a Loophole That Isn’t, Biospace (Sept. 17, 2025), https://www.biospace.com/policy/in-new-dtc-ad-crackdown-fda-trying-to-close-a-loophole-that-isnt (citing Lucy Rose, A Response and Suggested Path Forward to FDA’s Fact Sheet, LinkedIn (Sept. 15, 2025), https://www.linkedin.com/pulse/response-suggested-path-forward-fdas-fact-sheet-ensuring-lucy-rose-jrple/?trackingId=h8%2BVIWXVSpKr4lMOeqQnQA%3D%3D).

[11] See James A. Boiani, et al., HHS, FDA Target Direct-to-Consumer Drug Advertising: A Paradigm Shift in Patient-Focused Communications, 15 Nat’l L. Rev. 278, 278 (Sept. 29, 2025), https://www.healthlawadvisor.com/hhs-fda-target-direct-to-consumer-drug-advertising-a-paradigm-shift-in-patient-focused-communications (explaining the importance the adequate provision).

[12] Id.

[13] Id.

[14] Id. (discussing enforcement of existing law).

[15] Joanne S. Eglovitch, FDA Cracks Down on Drug Ads, Promises to End the Adequate Provision ‘Loophole’, Regul, Focus (Sept. 10, 2025), https://www.raps.org/news-and-articles/news-articles/2025/9/fda-cracks-down-on-drugs-ads,-promises-to-end-adeq (“[T]ruthful and non-misleading DTC advertising is protected under the First Amendment and has documented evidence of advancing patient awareness and engagement.”)

[16] U.S. Food & Drug Admin., supra note 3 (citing Mor, et. al., Pharmaceutical Industry Promotional Activities on Social Media: A Scoping Review, 15 J. Pharm. Health Servs. Rsch. 1 (2024)).

[17] Id.

[18] Id.

[19] Id.

[20] 21 C.F.R. 202.1(e)(1)(i)(B).

[21] U.S. Food & Drug Admin., supra note 3 (emphasis added).

[22] Boiani, supra note 11.

[23] See Eglovitch, supra note 15 (discussing potential litigation on First Amendment grounds).

[24] See HHS and FDA Declare “Crackdown” on Drug Advertising and Promotion, King & Spalding (Sept. 10, 2025), https://www.kslaw.com/news-and-insights/hhs-and-fda-declare-crackdown-on-drug-advertising-and-promotion (“[The FDA] has not specifically addressed the presentation of the ‘brief summary’”).

[25] Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format, 88 Fed. Reg. 80958 (Nov. 21, 2023) (to be codified at 21 C.F.R. pt. 202).

[26] U.S. Food & Drug Admin., supra note 7.

I Feel the Rush: Chemsex and Consent Laws

June 17, 2025
Food and Drug Law, Health Law, Psychology

Violet Butler, MJLST Note/Comment Editor

Sex and drugs don’t mix. Or do they? A scroll on the popular LGBTQ+ hookup and dating app Grindr will show many users looking to have a good time (in more ways than one). Chemsex, more commonly known as “Party and Play” in the United States, is the practice of using psychoactive drugs as a part of having sex.[1] Chemsex became more popular amongst queer men in recent years, with over ten percent of queer men in the United States reporting engaging in chemsex in a 2021 study. The same study found it was more popular in the global community.[2] With the surging prevalence of chemsex across the world, is our legal system capable of handling chemsex?

The practice may seem odd—or even dangerous—to some, but there are a variety of reasons why queer men might engage in chemsex. A study out of Kazakhstan found that people commonly engage in chemsex for self-empowerment, sexual liberation, detachment, and as part of social dynamics.[3] Whatever their personal reason for doing so, the men who engage in chemsex acknowledge its risks. The men in the aforementioned Kazakh study described risks associated with mental health, physical health, and the risk of violence.[4] One of the largest risks is how psychoactive substances such as GHB or meth—some of the drugs commonly used in chemsex—renders users mentally incapacitated.[5]

Because the law is not currently set up to handle the voluntary intoxication associated with chemsex, it is helpful to understand how those who choose to participate in chemsex create their own subcultural understanding of consent when they can no longer rely on the law. A gay male from Chicago said that consent in chemsex is often based on the ability to read body language or facial expressions instead of verbal affirmations of consent.[6] This can make ensuring consent in a chemsex encounter more difficult, and he said that “people give somewhat more grace to anyone who initiates unwanted contact” during a chemsex encounter because of these fuzzy lines of consent.[7] Additionally, chemsex participants report that people can change behavior and preferences when under the influence of drugs, which can create feelings of remorse after becoming sober.[8] In order to navigate these messy lines of consent, some chemsex participants give forward-looking consent to “whatever happens … (within reason).”[9] More concerningly, some chemsex participants have reported feeling as if they have “relinquished any version of consent” when drugs become involved.[10] Although many individual chemsex encounters may be perfectly consensual, it seems that chemsex does not have the same clear culture of consent found in other sexual subcultures, such as kink (or BDSM) culture.

But can the law fix this problem? Considering the heavy risks involved in chemsex and a possibly fuzzy culture of consent, this question doesn’t have a clear answer. One possible solution is the use of sexual advance directives. More commonly seen in the healthcare world, advanced directives can either be instructive directives (giving or blocking consent for future actions) or proxy directives (authorizing a third party to give consent in the person’s stead).[11] The use of sexual advanced directives could clear up the issues of fuzzy, “in the moment,” consent that is common in chemsex, providing guardrails for people who are at high risk of sexual exploitation. Instructive sexual advanced directives could provide a list of “dos and don’ts” or “yesses and noes” that all parties sign onto in advance. The primary benefit of these instructive directives is that they would set out clear expectations for all participants, hopefully reducing any crossing of lines. However, using substances such as meth can have a strong impact on one’s behavior and there is no guarantee that the boundaries signed onto while sober will still be respected once the participants start using drugs. Chemsex users have reported violence associated with drug use as a major concern in the chemsex community.[12] If an accusation of consent being crossed arises after the fact, an instructive sexual advanced directive could help clarify what was and was not consented to before drugs got involved.

The use of proxy sexual advanced directives could provide another layer of protection for chemsex encounters. Participants would have one or more, depending on the size of the chemsex encounter, people be their proxies, giving these proxies the power to step in and make consent decisions for them in situations where it might seem like consent has gotten fuzzy.[13] While it may seem awkward for a sober third party to just be sitting and watching someone have sex, the use of consent proxies can prevent a situation from going too far when chemsex participants can no longer advocate for themselves in a situation.

Ultimately, even if legal systems can be set up to protect chemsex participants, it will take both public health campaigns and community buy-in to create a stronger and clearer culture of consent in the chemsex scene. Absent legal guardrails, some steps can be taken to ensure a safer chemsex encounter, such as only participating in it with a trusted partner and being familiar with the drug being used.

 

Notes

[1] Viiv Healthcare, Chemsex: Navigating Pleasure, Safety, and Health, 2021,https://viivhealthcare.com/ending-hiv/stories/community-engagement/chemsex/#:~:text=In%20the%20USA%2C%2010.3%25%20of,in%20the%20past%2012%20months.

[2] Id.

[3] Lunchenkov et al., “A Way to Liberate Myself”: A Qualitative Study of Perceived Benefits and Risks of Chemsex Among Gay, Bisexual, and Other Men Who Have Sex with Men in Almaty, Kazakhstan, Drug & Alcohol Dependence 1, 5–6 (Oct. 10. 2024).

[4] Id. at 7.

[5] Viiv Healthcare, supra note i. See also, Alexander A. Boni-Saenz, Sexuality and Incapacity, 76 Ohio State L.J., 1201, 1212 (2015) (giving intoxication as an example of “temporary transient incapacity”).

[6] Interview with a Gay Man Living in Chicago (Feb. 11, 2025) (on file with author).

[7] Id.

[8] Healy-Cullen et. al., Understanding How Gay Men Construct ‘Good’ Chemsex Participation Using Critical Discursive Psychology,15 Psych. & Sexuality 539, 548 (2024).

[9] Interview with a Gay Man Living in Chicago, supra note viii.

[10] Zachary Zane, It’s Time to Talk About Chemsex and Consent, Advoc., (Sept. 11, 2017 7:00 AM) , https://www.advocate.com/current-issue/2017/9/11/its-time-talk-about-chemsex-and-consent#toggle-gdp.

[11] Alexander A. Boni-Saenz, Sexual Advance Directives, 68 Ala. L. Rev. 1, 11 (2016).

[12] Lunchenkov et al., supra note iii at 7.

[13] It is also possible to have some combination of written instructive and proxies to ensure the most clarity in sexual encounters. See, Alexander A. Boni-Saenz, supra note xii at 12–13 for a brief introduction to hybrid directives.

The New Reefer Madness? New Laws Look to Regulate Hemp Products

October 11, 2024
Administrative Law, Food and Drug Law

Violet Butler, MJLST Staffer

In 2018, the federal government took a major step in shifting its policy towards the criminalization of marijuana. Included in the 2018 Farm Bill was a provision that legalized some hemp-derivative products, in particular CBD products with a low-level of THC.[1] While this was touted by the industry and activists as a major step forward, the move to increase regulations on these hemp products have recently gained steam.

But what exactly was legalized by the federal government? The 2018 Farm Bill legalized hemp and hemp derived products (including CBD) that contain no more than 0.3% THC.[2] It should be noted that most cannabis products are consumed for some form of intoxication[3] and, suffice it to say, intoxication does not arise from 0.3% THC. The 2018 Farm Bill legalized a very small subsection of cannabis products serving a limited range of uses. Under the law, if a product contains more than 0.3% THC it is legally classified as marijuana and is still illegal under the Controlled Substances Act. So, if these new products cannot be used as intoxicants, why is there a push for more regulations?

A reason for the push for further regulations gaining traction is the concern over synthetically produced cannabinoids. A report from the National Academy of Sciences, Engineering, and Medicine recently published a report urging the federal government to redefine what “hemp” means. This is in an effort to ban semi-synthetic cannabinoids derived from legal hemp products as these cannabinoids can mirror the intoxicating effects of marijuana.[4] By clamping down on these semi-synthetic products, the legal line between hemp, CBD, and marijuana can be more properly maintained.

Different states are taking different approaches to the new regulations on hemp products. One camp of lawmakers want to go back to the old regime where any miniscule trace of THC was illegal. This “total ban” approach is presently seen in new legislation passed in Arkansas. Arkansas’ Act 629 bans the “production and sale of products containing Delta 8, Delta 9 and Delta 10 and other THC isomers inside the state of Arkansas” in any capacity.[5] Currently on appeal in the Eighth Circuit, the act has been subject to a lawsuit from hemp companies claiming the state law is preempted by the 2018 Farm Bill.[6] Arkansas is not the only state to take a total ban approach. Missouri’s governor Mike Parsons recently signed an executive order banning all consumables containing “psychoactive cannabis products”—or hemp products containing even trace amounts of THC—outside of the state’s already regulated cannabis market.[7] While this is not as broad in scope as Arkansas’ ban, the wide-reaching ban restricts the sale of most non-marijuana cannabis products in the state.

However, some states have taken a different approach to regulating hemp products, particularly in its distribution. New Jersey recently banned any amount of THC from being sold to a person under the age of 21.[8] California governor Gavin Newsom took a similar approach, signing an emergency ban on all hemp products containing THC and restricting the sale of all other hemp products to the 21+ market.[9] Even the federal government might be looking to increase the regulations on hemp products. Senator Ron Wyden recently introduced a bill that would raise the age at which someone could buy hemp products to 21 and set more federal safety standards on the industry.[10]

So, why is there a push to change the laws around hemp now? It could come down to perceived health risks and a rise in hospitalizations. A study from the Nationwide Children’s Hospital found that there were over 3,000 calls to poison controls related to THC, including the those found in small doses of legal hemp products.[11] Although only about 16% of these calls resulted in hospitalizations, roughly half of admissions were for children under 6-years-old.[12] California Governor Newsom directly cited hospitalizations as one the principal reasons he signed his emergency order.[13]

People seem to be worried about the hemp products currently on the market, including CBD, but should they be? The jury is still out on the health effects of CBD. A report from the World Health Organization in 2018 said that CBD had a “good safety profile” and reported no evidence of detrimental effects from recreational consumption of pure CBD.[14] However, the AAMC notes that CBD is understudied and there could be adverse interactions if CBD is taken with other medications.[15]

Legislators and policy-makers need to be able to ensure the safety and well-being of their citizens without creating unnecessary barriers for a new and growing industry. One of the barriers that states are facing is— maybe ironically—the 2018 Farm Bill. The bill opened the door for hemp products that met the THC standards, and these state laws are running into friction with the federal law. While states are allowed (and expected) to regulate the hemp industry under the 2018 Farm Bill, the move by many states to put heavier restrictions on the amount of THC allowed in hemp products seems to be in conflict with federal law. The lawsuits from hemp producers so far have all revolved around the idea that these state regulations, which are more restrictive than the 2018 Farm Bill, are preempted by the federal legislation.[16] Under Article VI of the Constitution, federal laws are the “supreme law of the land” so the Farm Bill must preempt state law in some way, but the exact way it does so is unclear.[17] There are two different ideas on how the Farm Bill preempts state law. The first idea is that the hemp regulations laid out in the federal law are the most stringent that states can regulate. This is the interpretation that hemp producers prefer, and the theory that they are suing under. The second idea, the option preferred by states that are looking to increase regulations, is that the Farm Bill set the outer limit for regulations. In other words, states are free to increase the regulations on the industry, but the federal law provides a national baseline if states do not come up with their own regulation.

Court rulings on this issue may settle the debate, but there is always a risk of a circuit split forming as different Courts of Appeal hear and decide on different lawsuits. To clear confusion once and for all, the federal government could clarify the scope of regulatory power with new legislation, or the Supreme Court could decide the issue in its upcoming term. But, until then, the legal challenges are likely to keep mounting and leave the nascent hemp industry in lingo.

 

Notes

[1] Dennis Romero, Hemp Industry Expected to Blossom Under New Farm Bill, NBC News (Dec. 17, 2018, 4:02 PM), https://www.nbcnews.com/news/us-news/hemp-industry-expected-blossom-under-new-farm-bill-n947791. For clarification, CBD stands for cannabidiol, a product derived from hemp, often sold in gummy or oil form. THC stands for tetrahydrocannabinol, the psychoactive part of the marijuana plant that can get you high. THC often refers to what is known as delta-9 THC, a type of THC found in the marijuana plant.

[2] John Hudak, The Farm Bill, Hemp Legalization and the Status of CBD: An Explainer, Brookings Institution (Dec. 14, 2018), https://www.brookings.edu/articles/the-farm-bill-hemp-and-cbd-explainer/

[3] As the Brookings Institution points out, the extremely low levels of THC in now-legal hemp products means that these products cannot be used to get high.

[4] Sam Reisman, New Report Urges Feds to Take Larger Role in Pot Policy, Law360 (Sept. 26, 2024, 8:53 PM), https://plus.lexis.com/newsstand/law360/article/1883058/?crid=c6fd0d9a-971e-489f-a5c6-8c1725ffee87

[5] Dale Ellis, Federal Judge Blocks State’s New Law Banning Delta-8 THC Products, Arkansas Democrat Gazette (Sept. 7, 2023, 6:00 PM), https://www.arkansasonline.com/news/2023/sep/07/federal-judge-blocks-states-new-law-banning-delta-8-thc-products/

[6] Sam Reisman, Court Defers Ruling On Challenge To Arkansas Hemp Law, Law360 (Sept. 25, 2024, 6:50 PM), https://plus.lexis.com/newsstand/law360/article/1882683/?crid=48cd5145-0817-47a7-bf22-1fb3bf01cb5f

[7] Jonathan Capriel, Missouri Ban on Some Psychoactive Foods to Hit Sept. 1 (August 30, 2024, 8:47 PM), https://plus.lexis.com/newsstand/law360/article/1882683/?crid=48cd5145-0817-47a7-bf22-1fb3bf01cb5f;  Rebecca Rivas, Missouri Hemp Leaders File Suit to Halt Governor’s Ban on Hemp THC Products, Missouri Independent (August 30, 2024 5:55 AM), https://missouriindependent.com/2024/08/30/missouri-hemp-leaders-set-to-file-suit-to-halt-governors-ban-on-hemp-thc-products/

[8] Sophie Nieto-Munoz, Gov. Murphy Signs Controversial Bill Restricting Sales of Hemp Products, New Jersey Monitor (Sept. 13, 2024, 7:11 AM), https://newjerseymonitor.com/2024/09/13/gov-murphy-signs-controversial-bill-restricting-sales-of-hemp-products/

[9] Rae Ann Varona, Calif. Gov.’s Emergency Hemp Intoxicant Ban Wins Approval, Law360 (Sept. 24, 2024, 9:49 PM),  https://plus.lexis.com/newsstand/law360/article/1882121/?crid=642ddd2e-a29d-46d6-8ff4-b7f209fd6c7f&cbc=0,0

[10] Same Reisman, Wyden Pitches New Bill To Regulate Intoxicating Hemp, Law360 (Sept. 25, 2024, 7:06 PM), https://plus.lexis.com/newsstand/law360/article/1882226/?crid=ed53b57f-dd97-4a6a-8a89-f6028f95e523

[11] Nationwide Children’s, New Study Finds Increase in Exposures to Synthetic Tetrahydrocannabinols Among Young Children, Teens, and Adults, Nationwide Children’s Hospital (May 7, 2024), https://www.nationwidechildrens.org/newsroom/news-releases/2024/05/deltathc_clinicaltoxicology

[12] Id.

[13] Varona, supra note 9.

[14] World Health Organization, Cannabidiol (CBD) Critical Review Report 5 (2018).

[15] Stacy Weiner, CBD: Does It Work? Is It Safe? Is It Legal?, AAMC News (July 20, 2023), https://www.aamc.org/news/cbd-does-it-work-it-safe-it-legal

[16] Reisman, supra note 6; Varona, supra note 9.

[17] U.S. Const. art. VI, cl. 2

The Double-Helix Dilemma: Navigating Privacy Pitfalls in Direct-to-Consumer Genetic Testing

November 7, 2023
Administrative Law, Biotechnology, Data, Ethics, Food and Drug Law, Health Law, Healthcare, Privacy

Ethan Wold, MJLST Staffer

Introduction

On October 22, direct-to-consumer genetic testing (DTC-GT) company 23andME sent emails to a number of its customers informing them of a data breach into the company’s “DNA Relatives” feature that allows customers to compare ancestry information with other users worldwide.[1] While 23andMe and other similar DTC-GT companies offer a number of positive benefits to consumers, such as testing for health predispositions and carrier statuses of certain genes, this latest data breach is a reminder that before choosing to opt into these sorts of services one should be aware of the potential risks that they present.

Background

DTC-GT companies such as 23andMe and Ancestry.com have proliferated and blossomed in recent years. It is estimated over 100 million people have utilized some form of direct-to-consumer genetic testing.[2] Using biospecimens submitted by consumers, these companies sequence and analyze an individual’s genetic information to provide a range of services pertaining to one’s health and ancestry.[3] The October 22 data breach specifically pertained to 23andMe’s “DNA Relatives” feature.[4] The DNA Relatives feature can identify relatives on any branch of one’s family tree by taking advantage of the autosomal chromosomes, the 22 chromosomes that are passed down from your ancestors on both sides of your family, and one’s X chromosome(s).[5] Relatives are identified by comparing the customer’s submitted DNA with the DNA of other 23andMe members who are participating in the DNA Relatives feature.[6] When two people are found to have an identical DNA segment, it is likely they share a recent common ancestor.[7] The DNA Relatives feature even uses the length and number of these identical segments to attempt to predict the relationship between genetic relatives.[8] Given the sensitive nature of sharing genetic information, there are often privacy concerns regarding practices such as the DNA Relatives feature. Yet despite this, the legislation and regulations surrounding DTC-GT is somewhat limited.

Legislation

The Health Insurance Portability and Accountability Act (HIPAA) provides the baseline privacy and data security rules for the healthcare industry.[9] HIPAA’s Privacy Rule regulates the use and disclosure of a person’s “protected health information” by a “covered entity.[10] Under the Act, the type of genetic information collected by 23andMe and other DTC-GT companies does constitute “protected health information.”[11] However, because HIPAA defines a “covered entity” as a health plan, healthcare clearinghouse, or health-care provider, DTC-GT companies do not constitute covered entities and therefore are not under the umbrella of HIPAA’s Privacy Rule.[12]

Thus, the primary source of regulation for DTC-GT companies appears to be the Genetic Information Nondiscrimination Act (GINA). GINA was enacted in 2008 for the purpose of protecting the public from genetic discrimination and alleviating concerns about such discrimination and thereby encouraging individuals to take advantage of genetic testing, technologies, research, and new therapies.[13] GINA defines genetic information as information from genetic tests of an individual or family members and includes information from genetic services or genetic research.[14] Therefore, DTC-GT companies fall under GINA’s jurisdiction. However, GINA only applies to the employment and health insurance industries and thus neglects many other potential arenas where privacy concerns may present.[15] This is especially relevant for 23andMe customers, as signing up for the service serves as consent for the company to use and share your genetic information with their associated third-party providers.[16] As a case in point, in 2018 the pharmaceutical giant GlaxoSmithKline purchased a $300 million stake in 23andMe for the purpose of gaining access to the company’s trove of genetic information for use in their drug development trials.[17]

Executive Regulation

In addition to the legislation above, three different federal administrative agencies primarily regulate the DTC-GT industry: the Food and Drug Administration (FDA), the Centers of Medicare and Medicaid services (CMS), and the Federal Trade Commission (FTC). The FDA has jurisdiction over DTC-GT companies due to the genetic tests they use being labeled as “medical devices”[18] and in 2013 exercised this authority over 23andMe by sending a letter to the company resulting in the suspending of one of its health-related genetic tests.[19] However, the FDA only has jurisdiction over diagnostic tests and therefore does not regulate any of the DTC-GT services related to genealogy such as 23andMe’s DNA Relatives feature.[20] Moreover, the FDA does not have jurisdiction to regulate the other aspects of DTC-GT companies’ activities or data practices.[21] CMS has the ability to regulate DTC-GT companies through enforcement of the Clinical Laboratory Improvements Act (CLIA), which requires that genetic testing laboratories ensure the accuracy, precision, and analytical validity of their tests.[22] But, like the FDA, CMS only has jurisdiction over tests that diagnose a disease or assess health.[23]

Lastly, the FTC has broad authority to regulate unfair or deceptive business practices under the Federal Trade Commission Act (FTCA) and has levied this authority against DTC-GT companies in the past. For example, in 2014 the agency brought an action against two DTC-GT companies who were using genetic tests to match consumers to their nutritional supplements and skincare products.[24] The FTC alleged that the companies’ practices related to data security were unfair and deceptive because they failed to implement reasonable policies and procedures to protect consumers’ personal information and created unnecessary risks to the personal information of nearly 30,000 consumers.[25] This resulted in the companies entering into an agreement with the FTC whereby they agreed to establish and maintain comprehensive data security programs and submit to yearly security audits by independent auditors.[26]

Potential Harms

As the above passages illustrate, the federal government appears to recognize and has at least attempted to mitigate privacy concerns associated with DTC-GT. Additionally, a number of states have passed their own laws that limit DTC-GT in certain aspects.[27] Nevertheless, given the potential magnitude and severity of harm associated with DTC-GT it makes one question if it is enough. Data breaches involving health-related data are growing in frequency and now account for 40% of all reported data breaches.[28] These data breaches result in unauthorized access to DTC-GT consumer-submitted data and can result in a violation of an individual’s genetic privacy. Though GINA aims to prevent it, genetic discrimination in the form of increasing health insurance premiums or denial of coverage by insurance companies due to genetic predispositions remains one of the leading concerns associated with these violations. What’s more, by obtaining genetic information from DTC-GT databases, it is possible for someone to recover a consumer’s surname and combine that with other metadata such as age and state to identify the specific consumer.[29] This may in turn lead to identity theft in the form of opening accounts, taking out loans, or making purchases in your name, potentially damaging your financial well-being and credit score. Dealing with the aftermath of a genetic data breach can also be expensive. You may incur legal fees, credit monitoring costs, or other financial burdens in an attempt to mitigate the damage.

Conclusion

As it sits now, genetic information submitted to DTC-GT companies already contains a significant volume of consequential information. As technology continues to develop and research presses forward, the volume and utility of this information will only grow over time. Thus, it is crucially important to be aware of risks associated with DTC-GT services.

This discussion is not intended to discourage individuals from participating in DTC-GT. These companies and the services they offer provide a host of benefits, such as allowing consumers to access genetic testing without the healthcare system acting as a gatekeeper, thus providing more autonomy and often at a lower price.[30] Furthermore, the information provided can empower consumers to mitigate the risks of certain diseases, allow for more informed family planning, or gain a better understanding of their heritage.[31] DTC-GT has revolutionized the way individuals access and understand their genetic information. However, this accessibility and convenience comes with a host of advantages and disadvantages that must be carefully considered.

Notes

[1] https://www.reuters.com/world/us/23andme-notifies-customers-data-breach-into-its-dna-relatives-feature-2023-10-24/#:~:text=%22There%20was%20unauthorized%20access%20to,exposed%20to%20the%20threat%20actor.%22

[2] https://www.ama-assn.org/delivering-care/patient-support-advocacy/protect-sensitive-individual-data-risk-dtc-genetic-tests#:~:text=Use%20of%20direct%2Dto%2Dconsumer,November%202021%20AMA%20Special%20Meeting

[3] https://go-gale-com.ezp3.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[4] https://www.reuters.com/world/us/23andme-notifies-customers-data-breach-into-its-dna-relatives-feature-2023-10-24/#:~:text=%22There%20was%20unauthorized%20access%20to,exposed%20to%20the%20threat%20actor.%22

[5] https://customercare.23andme.com/hc/en-us/articles/115004659068-DNA-Relatives-The-Genetic-Relative-Basics

[6] Id.

[7] Id.

[8] Id.

[9] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[10] https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/combined/hipaa-simplification-201303.pdf

[11] Id.

[12] Id; https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[13] https://www.eeoc.gov/statutes/genetic-information-nondiscrimination-act-2008

[14] Id.

[15] https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC3035561&blobtype=pdf

[16] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[17] https://news.yahoo.com/news/major-drug-company-now-access-194758309.html

[18] https://uscode.house.gov/view.xhtml?req=(title:21%20section:321%20edition:prelim)

[19] https://core.ac.uk/download/pdf/33135586.pdf

[20] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[21] Id.

[22] https://www.law.cornell.edu/cfr/text/42/493.1253

[23] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[24] https://www.ftc.gov/system/files/documents/cases/140512genelinkcmpt.pdf

[25] Id.

[26] Id.

[27] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[28] Id.

[29] https://go-gale-com.ezp2.lib.umn.edu/ps/i.do?p=OVIC&u=umn_wilson&id=GALE%7CA609260695&v=2.1&it=r&sid=primo&aty=ip

[30] Id.

[31] Id.

The Inaccessible Cure: the Struggle With Feline Infectious Peritonitis and Thoughts on the Underlying Law

October 10, 2023
Administrative Law, Food and Drug Law, Health Law, Intellectual Property, Patents

Lan Gan, MJLST Staffer

For fellow feline fanatics, you may share some of my traits. I care for my cat’s health as I care for my own. Besides giving her nutritiously balanced meals, I take notes when she’s unwell and schedule annual physicals for her, just like I would for myself. I also browse online discussions posts of cats. Some make me laugh, some give me new understanding of cat behaviors, but the ones about feline infectious peritonitis are always grim.

Feline Infectious Peritonitis, or FIP, is a severe disease that typically develops in young cats when they are infected with feline enteric coronavirus (FeCV) which later mutates into FIPV and causes inflammations.[1] The mutations happen about ten percent of the time, and, until recently, have almost always been deadly.[2]

In 2018, researchers at the School of Veterinary Medicine at UC Davis partnered with Gilead Sciences and published an article about the discovery of GS-441524, which, through their experiments with cats that were infected with FIPV in an in vitro process, “caused a rapid reversal of disease signs and return to normality with as little as two weeks of treatment in 10/10 cats and with no apparent toxicity.”[3] Another paper, published in 2019, also by researchers of the two institutions, revealed that GS-441524 was an effective treatment for cats with naturally occurring FIP.[4]

This gave cat rescuers and cat owners hope. But despite promising experiment results, Niels Pederson, who partook in the studies and was a long-time researcher devoted to FIP, warned that the development was “proof-of-concept,” showing possibility in terms of science but not immediately translating into commercially available products.[5] Subsequently, GS-441524 did not move forward to become an FDA-approved drug to treat cats.[6] Instead, it seemed to be set aside as Gilead prioritized another drug, remdesivir, which is identical to GS-441524 in part of its structural formula and has the same mechanism of inhibiting coronavirus.[7] When Gilead failed to obtain FDA approval to use remdesivir to treat Ebola, they changed course to study its effects on the then-rising Covid-19 pandemic.[8] GS-441524, with its studies on animals halted, was also part of the race and was argued by some scientists to have more efficacy in treating Covid-19 than remdesivir.[9]

The much-needed cure became inaccessible. In as early as 2019, anxious people were turning to the black market for help. GS-441524 that circulated on the black market had murky origins: potential leaks from lab orders for research, personnel that synthesized the compound themselves in overseas locations such as China.[10] The benefits of the drug, while still salient, based on surveys of cat owners who utilized them, were potentially compromised by the disparity in quality of the black market drugs, and lack of veterinary expertise involved.[11]

Pharmaceutical companies are more than incentivized to patent their research products. A search on World Intellectual Property Organization (WIPO)’s database revealed 66 patents applied for by Gilead, from as early as 2009 to as recently as July 2023.[12] The list of patents documented development in Gilead’s GS-441524 research.[13] Gilead patented GS-441524’s treatment for cats in 2018 and 2020[14], but those accounted for only 3 of the 66 patents they obtained; the rest were regarding human use.[15] Patents benefit their owners by giving them a cause of action against future infringement. They are about owning, not sharing. Patents are the culmination of a strenuous journey of scientific research. But this celebratory landmark might not go any further. Many patents do not make their way onto the market; having one is not itself an incentive for doing so.

Next comes the approval process as stipulated in federal law. 21 U.S.C. § 360b governs the approval process of new animal drugs.[16] The statute lays the burden on pharmaceutical companies – referred to as drug sponsors – of contacting the FDA after initial research of the drug, making the decision to pursue approval for the drug, and conducting tests to ensure the effectiveness and safety of the drug.[17] Additionally, the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988 provides an abbreviated process for generic copies of approved new animal drugs;[18] the Minor Use and Minor Species Animal Health Act (the “Mums Act”) of 2004 paves paths for drugs affecting a small population of major species of animals (defined as horses, dogs, cats, cattle, pigs, turkeys and chickens) and minor species (those that are not major species) that have few drugs available to them.[19] In 2018, the Animal Drug and Animal Generic Drug User Fee Amendments expanded the eligibility for conditional approval of non-MUMS drugs intending to treat a serious or life-threatening disease or condition or address an unmet animal or human health need, for which a demonstration of effectiveness would require a complex or particularly difficult study or studies.[20]

How has GS-441524 escaped the statutory provisions when they have been amended to be more inclusive? There may be various reasons. It may not qualify for conditional approval under 21 U.S.C. § 360ccc(a)(1)(ii) because peer-reviewed articles have already demonstrated the drug’s effectiveness. It may be hard to quantify the FIP-affected cat population to meet the “minor use” threshold set out in the Mums Act because of the difficulty of FIP testing. Current testing cannot differentiate between FeCV and the mutated FIPV, and an FIP diagnosis is often assumed for young cats based on their higher infection rate.[21] Lastly, no matter which approval process GS-441524 is eligible to take, the process wouldn’t start unless Gilead decides to contact the FDA and set forth the drug for approval. Current statutes create paths, but no incentives to do so. The market may provide some monetary incentives, as treatment costs via the black market can be up to $10,000 for 12 weeks[22], but this is singularly held back by the decision to prioritize approval for human treatment, and the presumption that the approval process of an animal drug would negatively impact the approval process of a similar drug for humans.[23]

The black market is not a long-term solution for FIP treatment. Though the U.S. has yet to adjudicate the circulation of unlicensed FIP treatment, in July 2023, a woman in China was sentenced to 15 years in prison and fined with more than $5 million in damages for producing and selling fake, substandard products pursuant to China’s criminal law statutes.[24] Gilead also holds the exclusive patents on feline treatments. Facing unclear prospects for legitimate FIP treatment, subsequent statutory amendments need to create actual incentives to spur innovation in animal drugs, in addition to the creation of paths. The law should also create safeguards to promote transparency and fairness in the application review process in order to reduce bias against animal drugs.

Notes

[1] Feline Infectious Peritonitis, Cornell Feline Health Center, https://www.vet.cornell.edu/departments-centers-and-institutes/cornell-feline-health-center/health-information/feline-health-topics/feline-infectious-peritonitis (last visited Oct. 2, 2023).

[2] Id.

[3] B.G. Murphy et al., The Nucleoside Analog GS-441524 Strongly Inhibits Feline Infectious Peritonitis (FIP) Virus in Tissue Culture and Experimental Cat Infection Studies, 219 Veterinary Microbology 226, 226 (2018).

[4] Niels C Pedersen, Efficacy and Safety of the Nucleoside Analog GS-441524 for Treatment of cats with Naturally Occurring Feline Infectious Peritonitis, 21(4) J. of Feline Med. & Surgery 271, 271 (2019).

[5] Human Antiviral ‘GS-441524’ Shows Great Promise Against Infectious Disease in Cats, Science Daily (Feb. 13, 2019), https://www.sciencedaily.com/releases/2019/02/190213100442.htm.

[6] Sarah Zhang, A Much-Hyped COVID-19 Drug Is Almost Identical to a Black-Market Cat Cure, The Atlantic (May 8, 2020), https://www.theatlantic.com/science/archive/2020/05/remdesivir-cats/611341/.

[7] Id.

[8] Kai Kupferschmidt & Jon Cohen, WHO Launches Global Megatrial of the Four Most Promising Coronavirus Treatments, Science (Mar. 22, 2020), https://www.science.org/content/article/who-launches-global-megatrial-four-most-promising-coronavirus-treatments.

[9] E.g., Victoria C. Yan & Florian L. Muller, Advantages of the Parent Nucleoside GS-441524 over Remdesivir for Covid-19 Treatment, 11 ACS Med. Chemistry Letters 1361, 1361 (2020).

[10] See Sarah Zhang, A Much-Hyped COVID-19 Drug Is Almost Identical to a Black-Market Cat Cure, The Atlantic (May 8, 2020), https://www.theatlantic.com/science/archive/2020/05/remdesivir-cats/611341/; see also Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2258 (2021).

[11] Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2264–67 (2021).

[12] CHEM:(BRDWIEOJOWJCLU-LTGWCKQJSA-N), WIPO, https://patentscope.wipo.int/search/en/result.jsf?_vid=P22-LN8EIR-06824 (last visited Oct. 2, 2023).

[13] Id.

[14] See World Patent No. 169,946 (filed Mar. 13, 2018); see also U.S. Patent No. 0,296,584 (filed Mar. 13, 2018); see also U.S. Patent No. 0,376,014 (filed Apr. 17, 2020).

[15] See CHEM:(BRDWIEOJOWJCLU-LTGWCKQJSA-N), WIPO, https://patentscope.wipo.int/search/en/result.jsf?_vid=P22-LN8EIR-06824 (last visited Oct. 2, 2023).

[16] 21 U.S.C. § 360b.

[17] From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process, FDA (Aug. 14, 2020), https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process.

[18] Generic Animal Drug and Patent Term Restoration Act (GADPTRA), FDA (Apr. 24, 2023), https://www.fda.gov/animal-veterinary/guidance-regulations/generic-animal-drug-and-patent-term-restoration-act-gadptra.

[19] Conditional Approval Explained: A Resource for Veterinarians, FDA (Sept. 17, 2020), https://www.fda.gov/animal-veterinary/resources-you/conditional-approval-explained-resource-veterinarians.

[20] 21 U.S.C. § 360ccc (a)(1)(ii).

[21] Feline Infectious Peritonitis, Cornell Feline Health Center, https://www.vet.cornell.edu/departments-centers-and-institutes/cornell-feline-health-center/health-information/feline-health-topics/feline-infectious-peritonitis (last visited Oct. 2, 2023).

[22] Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2264–67 (2021).

[23] Id.

[24] Wu Shubin (吴淑斌), Zhishou Maoyao Yishen Huoxing 15 Nian: Maoquan “Jiumingyao” de Yinmi Shengyi (制售猫药一审获刑15年:猫圈“救命药” 的隐秘生意) [Sentenced at Trial for 15 Years for Manufacturing and Selling Medicine for Cats: The Secret Business of Life-Saving Drugs in Cat-loving Communities], Sanlian Shenghuo Zhoukan (三联生活周刊) [Sanlian Lifeweek] (July 20, 2023), https://mp.weixin.qq.com/s/VKJO_AIVBy3Hm6GhWUOnWA.

Behind the “Package Insert”: Loophole in FDA’s Regulation of Off-Label Prescriptions

November 12, 2022
Administrative Law, Food and Drug Law, Health Law, Healthcare, Industry, Public Health

Yolanda Li, MJLST Staffer

FDA Regulation of Drug Prescription Labeling and the “Package Insert”

Over the recent years, constant efforts have been made towards regulating medical prescriptions in an attempt to reduce risks accompanied with drug prescriptions. Among those efforts is the FDA’s revision of the format of prescription drug information, commonly known as the “package insert”.[1]

The package insert regulation, effective since 2006, applies to all prescription drugs. The package insert is to provide up-to-date information on the drug in an easy-to-read format. One significant feature is a section named “highlights”, which provides the most important information regarding the benefits and risks of a prescribed medication. The highlights section is typically half a page in length providing a concise summary of information including “boxed warning”, “indications and usage”, and “dosage and administration”.[2] The highlights section also refers physicians to appropriate sections of the full prescribing information. In this way, the package insert aims to draw both the physicians’ and the patients’ attention to the prescription of a drug, consequently accomplishing the ultimate purpose of managing medication use and reducing medical errors. Mike Leavitt, the Health and Human Services Secretary of the FDA commented that the package insert “help[s] ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare.”[3]

FDA Regulation of Off-Label Prescription and the Emergence of a Loophole

The FDA’s regulations relating to the labeling of prescription drugs, although systematic in its form, are cut short to a certain extent due to its lack of regulation on off-label prescriptions. Off-label prescriptions do not refer to a physician prescribing non-FDA approved drugs, a common misunderstanding by the public. Rather, off-label prescriptions are those that do not conform to the FDA-approved use set out in the FDA-approved label.[4] More specifically, off-label prescription generally refers to: “(1) the practice of a physician prescribing a legally manufactured drug for purposes other than those indicated on that drug’s FDA mandated labeling; (2) using a different method of applying the treatment and prescribing a drug, device, or biologic to patient groups other than those approved by FDA; and (3) prescriptions for drug dosages that are different from the approved label-recommended dosage or for time periods exceeding the label-recommended usage.”[5] For example if Drug A’s use, as mandated by the FDA, is to treat chronic headaches, and a physician prescribes it to treat a patient’s sprained ankle, that is an off-label prescription. However, such practice is common as estimated by the American Medical Association (AMA).[6]

The commonly approach is that the FDA and courts do not to interfere with physicians’ off-label uses.[7] Thus, when the FDA regulates the labeling of approved uses but does not regulate prescriptions for off-label uses, a loophole is formed. Andrew von Eschenbach, M.D., claims that because the FDA’s package insert regulation makes it easier for physicians to get access to important information about drugs, including drug safety and benefits, this regulation helps physicians to have more meaningful discussions with patients.[8] However, physicians’ discretion in prescribing off-label prescriptions would offset the proposed benefit of the FDA regulation because the regulation remains as guidance without force of law once physicians choose to go off from FDA’s approved uses of drugs. The easy-to-understand feature of the package insert and its benefit for a patient’s understanding of the drug becomes futile when physicians exercise discretion and prescribe drugs for uses not written on the inserts. In sum, when a patient receives an off-label prescription, the insert provides them little benefit as it addresses benefits and risks related to a different use of the drug.

It is undisputed that drug manufacturers have less discretion regarding drug labeling than physicians. If a manufacturer included an off-label use on a drug’s label, and promoted the off-label use of the drug, the drug would be considered misbranded. The manufacturer would then be subject to liability[9] as manufacturing a misbranded product in interstate commerce is prohibited.[10] However, the effect of regulations on manufacturers still fail to eliminate the loophole in off-label prescription: in response to the regulations, the manufacturer usually receives FDA approval for only a few drug uses and then relies on physicians prescribing off-label uses to ensure their profitability.[11] In this way, the manufacturer avoids liability under regulation and furthers the loophole in off-label prescription by encouraging physicians to prescribe more off-label uses in order to expand the manufacturer’s market.[12]

Why are Off-Label Prescriptions Difficult to Regulate?

One of the main reasons behind the lack of regulation of off-label prescriptions is the FDA’s objective in ensuring effective delivery of health care. Physicians are encouraged to use discretion and judgment in order to tailor prescription to patients’ individual conditions.[13] Another reason is to increase efficiency in treatments by avoiding the lengthy FDA approval process.[14] Aspirin was widely prescribed to reduce the risk of heart attack long before it was FDA-approved for this purpose; off-label prescriptions have also been proven effective in treatment of cancer, and off-label therapies have prolonged the lives of AIDS patients.[15] Another concern is drug prices in the United States, and promoting off-label uses has been found to help reduce drug prices as increased sales volume enables drug companies to lower their prices.[16] Indeed, off-label prescription has become a mainstream of medicine: “the FDA has long tolerated off-label drug use and has disclaimed any interest in regulating physicians’ prescribing practices.”[17] Today it is unclear whether the agency even has jurisdiction to regulate off-label prescription of drugs.[18]

In sum, there is clear guidance on the labeling of prescription drugs as a result of FDA regulation. However, because of difficulties in enforcement, the custom and widely accepted practice of off-label prescriptions and the inherent benefit of off-label prescription, the effects of the regulation are not as effective as what was firstly planned and proposed.

Notes

[1] The FDA Announces New Prescription Drug Information Format, U.S. Food & Drug Adm’ (Dec. 04 2015) https://www.fda.gov/drugs/laws-acts-and-rules/fda-announces-new-prescription-drug-information-format.

[2] Id.

[3] Id.

[4] Margaret Z. Johns, Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest, 58 Hastings L.J. 967, 968 https://plus.lexis.com/document?crid=35364c11-2939-4e58-bceb-dab7ae8f0154&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A4P0W-GY20-00CW-906B-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7341&pdmfid=1530671&pdisurlapi=true.

[5] Lisa E. Smilan, The off-label loophole in the psychopharmacologic setting: prescription of antipsychotic drugs in the nonpsychotic patient population, 30 Health Matrix 233, 240 (2020), https://plus.lexis.com/document/?pdmfid=1530671&crid=367cf8ad-295e-4f14-97fa-737618718d61&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A64BT-RR31-JWBS-61KV-00000-00&pdworkfolderid=5506aeec-9540-4837-89f0-5a1acfd81d8b&pdopendocfromfolder=true&prid=1d42abd0-b66e-43af-a61a-0d1fb94180f5&ecomp=gdgg&earg=5506aeec-9540-4837-89f0-5a1acfd81d8b#.

[6] Supra note 4.

[7] Sigma-Tau Pharms. v. Schwetz, 288 F.3d 141, 148, https://plus.lexis.com/document?crid=7d2a2b00-13ad-4953-968e-82a28724aa00&pddocfullpath=%2Fshared%2Fdocument%2Fcases%2Furn%3AcontentItem%3A45RF-5H50-0038-X1PB-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=6388&pdmfid=1530671&pdisurlapi=true.

[8] Supra note 1.

[9] 21 CFR 201.5, https://plus.lexis.com/document/?pdmfid=1530671&crid=e02a99fb-be65-4525-b83c-a167f3e21b93&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A603K-BXD1-DYB7-W30Y-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr2.

[10] 21 CFR 801.4, https://plus.lexis.com/document/?pdmfid=1530671&crid=721a586d-52a4-4228-b0c3-c464a77d6e6a&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A638R-X4S3-GXJ9-32FV-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr6.

[11]  Supra note 4.

[12] Id.

[13]   Supra note 7.

[14]   Supra note 4.

[15]  Id.

[16] Supra note 4, at 981.

[17] ​​Kaspar J. Stoffelmayr, Products Liability And “Off-label” Uses Of Prescription Drugs, 63 U. Chi. L. Rev. 275, 279, https://plus.lexis.com/document?crid=a2181ffc-7f3e-4bce-b82e-08ba9111194f&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A3S3V-4CF0-00CV-K03W-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7358&pdmfid=1530671&pdisurlapi=true.

[18]  Id.

Beef (and Residual Hormones?). It’s What’s for Dinner.

November 6, 2022
Administrative Law, Agriculture, Environmental Law, Food and Drug Law, Health Law, Industry, Public Safety

Kira Le, MJLST Staffer

The beef industry in the United States has been using hormones, both natural and synthetic, to increase the size of cattle prior to slaughter for more than a century.[1] Capsules are implanted under the skin behind a cow’s ear and release specific doses of hormones over a period of time with the goal of increasing the animal’s size more quickly. Because the use of these hormones in the beef industry involves both drug regulation and food safety regulations, both the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) are responsible for ensuring the safety of the practice and regulating its use.[2] According to the FDA, “scientific data” is used to establish “acceptable” safe limits for hormones in meat by the time it is consumed.[3] Agricultural science experts support the fact that the naturally-occurring hormones used in beef production, such as estrogen, are used in amounts much smaller than those that can be found in other common foods, such as eggs and tofu.[4] However, the debate within the scientific community, and between jurisdictions that allow the sale of hormone-treated beef (such as the United States) and those that have banned its importation (such as the European Union), is still raging on in 2022 and has led to significant distrust in the beef industry by consumers.[5] With the release of research earlier this year presenting opposing conclusions regarding the safety of the use of synthetic hormones in the beef industry, the FDA has a responsibility to acknowledge evidence suggesting that such practices may be harmful to human health.

Some defend the use of hormones in the beef industry as perfectly safe and, at this point, necessary to sustainably feed a planet on which the demand for meat continues to increase with a growing population. Others, such as the European Union and China, both of which have restricted the importation of beef from cattle implanted with growth-promoting hormones, argue that the practice threatens human health.[6] For example, a report out of Food Research Collaboration found that a routinely-used hormone in United States beef production posed a significant risk of cancer.[7] Such a finding is reminiscent of when, in the not-too-distant past, known carcinogen diethylstilbestrol (DES) was used in U.S. cattle production and led to dangerous meat being stocked on grocery store shelves.[8]

This year, research published in the Journal of Applied Animal Research discussed the effects that residual hormones left in beef and the environment have on human health in the United States.[9] Approximately 63% of beef cattle in the United States are implanted with hormones, most of which are synthetic.[10] Despite organizations and agencies such as the FDA assuring consumers that the use of these synthetic hormones in cattle production is safe, the residues that can be left behind may be carcinogenic and/or lead to reproductive or developmental issues in humans.[11] Furthermore, the National Residue Program (NRP), housed in the USDA, is not only the “only federal effort that routinely examines food animal products for drug residues,” but also only examines tissues not commonly consumed, such as the liver and kidney.[12] Researchers Quaid and Abdoun offer the example of Zeranol, a genotoxic synthetic hormone used in beef production in the United States that activates estrogen receptors, causing dependent cell proliferation in the mammary glands that may result in breast cancer.[13] They also noted the problem of residual hormones found in the environment surrounding cattle production locations, which have been found to reduce human male reproductive health and increase the risk of some endocrine cancers.[14]

Also this year, researchers published an article in the Journal of Animal Science claiming that despite the “growing concern” of the effects of residual hormones on human health, including the earlier onset of puberty in girls and an increase in estrogen-related diseases attributed to the excessive consumption of beef, research shows that cattle treated with hormones, “when given at proper administration levels, do not lead to toxic or harmful levels of hormonal residues in their tissues.”[15] The researchers concluded that the hormones have no effect on human health and are not the cause of disease.[16]

Perhaps it is time for the FDA to acknowledge and address the scientific disagreements on the safety of the use of hormones – synthetic hormones, especially – in beef production, as well as reassure consumers that players in the agriculture industry are abiding by safety regulations. Better yet, considering the currentness of the research, the inconsistency of the conclusions, and the seriousness of the issue, formal hearings – held by either the FDA or Congress – may be necessary to rebuild the trust of consumers in the U.S. beef industry.

Notes

[1] Synthetic Hormone Use in Beef and the U.S. Regulatory Dilemma, DES Daughter (Nov. 20, 2016), https://diethylstilbestrol.co.uk/synthetic-hormone-use-in-beef-and-the-us-regulatory-dilemma/.

[2] Id.

[3] Steroid Hormone Implants Used for Growth in Food-Producing Animals, U.S. Food and Drug Admin (Apr. 13, 2022), https://www.fda.gov/animal-veterinary/product-safety-information/steroid-hormone-implants-used-growth-food-producing-animals.

[4] Amanda Blair, Hormones in Beef: Myths vs. Facts, S.D. State Univ. Extension (July 13, 2022), https://extension.sdstate.edu/hormones-beef-myths-vs-facts.

[5] See Julia Calderone, Here’s Why Farmers Inject Hormones Into Beef But Never Into Poultry, Insider (Mar. 31, 2016), https://www.businessinsider.com/no-hormones-chicken-poultry-usda-fda-2016-3 (discussing the debate within the scientific community over whether the use of hormones in animals raised for human consumption is a risk to human health).

[6] New Generation of Livestock Drugs Linked to Cancer, Rafter W. Ranch (June 8, 2022), https://rafterwranch.net/livestock-drugs-linked-to-cancer/.

[7] Id.

[8] Synthetic Hormone Use in Beef and the U.S. Regulatory Dilemma, DES Daughter (Nov. 20, 2016), https://diethylstilbestrol.co.uk/synthetic-hormone-use-in-beef-and-the-us-regulatory-dilemma/.

[9] Mohammed M. Quaid & Khalid A. Abdoun, Safety and Concerns of Hormonal Application in Farm Animal Production: A Review, 50 J. of Applied Animal Rsch. 426 (2022).

[10] Id. at 428.

[11] Id. at 429–30.

[12] Id. at 430.

[13] Id. at 432–33.

[14] Id. at 435.

[15] Holly C. Evans et al., Harnessing the Value of Reproductive Hormones in Cattle Production with Considerations to Animal Welfare and Human Health, 100 J. of Animal Sci. 1, 9 (2022).

[16] Id.

Making Moves on Marijuana: President Biden and Minnesota Update Marijuana Laws in 2022

October 23, 2022
Administrative Law, Employment Law, Food and Drug Law, Health Law, Public Health

Emma Ehrlich, MJLST Staffer

Federal Pardoning 

Earlier this month, President Biden announced that he would be pardoning anyone with a federal conviction due to simple marijuana possession charges. This will affect approximately 6,500 people on the federal level, plus thousands of others who were convicted in the District of Columbia. However, this pardon does not cover anyone involved in the actual sale of marijuana or anyone convicted under state possession laws, meaning it affects only a subsection of those who have been convicted of marijuana related charges. The administration’s goal was to give a clean slate to those who were struggling to find housing or employment due to a possession charge, and to encourage state legislatures to do the same. 

The second half of President Biden’s announcement was to task the Attorney General with reviewing the federal government’s categorization of marijuana as a Schedule 1 drug, which President Biden pointed out is currently the same categorization as heroin. Drugs are supposed to be assigned to schedules based on their medical uses and addictive qualities. The Drug Enforcement Agency (“DEA”) currently categorizes marijuana as a “drug[] with no currently accepted medical use and a high potential for abuse.” The U. S. Food and Drug Administration (“FDA”) explains on their website, almost in a regretful tone, that only four cannabis drugs have been approved by the FDA, one containing CBD and the other three containing synthetically derived THC. This categorization issue is not new, but because legislation regarding marijuana is changing rapidly federal agencies have had to play catch up with the law.  

Minnesota and Beyond 

Meanwhile, the state of Minnesota is still chugging along in terms of marijuana legalization. In July of this year, the state of Minnesota legalized the production and sale of edibles containing 5-mg of THC, which can now be purchased by adults in bags containing no more than 50-mg of THC. This sounds like good news, but many state residents are baffled at the lack of a tax provision in the new state law. The University of Maryland actually did a study on Minnesota’s potential for taxing cannabis, and determined that if the newly legalized edibles were taxed at the same rate as Michigan taxes, the state could have collected over $40 million. Given this high estimate, it is not out of the question that a tax on marijuana will be implemented in the future. 

Minnesotan employers were similarly not thrilled when the law passed as they felt ill equipped to update their drug policies. Employers “can bar workers from using, possessing, and being under the influence of THC during work hours or in the workplace,” as well as conduct “random drug testing for safety-sensitive positions” and “employees suspected of being intoxicated.” The gray area exists in the employer’s ability to hire and fire based on an applicant or employee’s use of marijuana outside of work. It is currently illegal to make hiring and firing decisions based on tobacco usage or alcohol consumption, and it is unclear if marijuana will be treated in the same manner. The added layer to marijuana testing is that a positive drug test for marijuana does not mean an employee consumed THC right before work since THC lingers in the body for so long. Thus, an employee could test positive for mairjuana at work even if they had used the drugs days ago and were no longer feeling its effects. Though the employee would have ingested the drug legally, they may not be considered for a job position or could be fired from a job they already hold. This is the type of issue that has led a number of municipalities in Minnesota to put a pause on the sale of the state legalized edibles. In contrast, California passed a law just last month protecting employees, apart from some exceptions, from being discriminated against based on their marijuana usage when not at work. What might be a little concerning is that California made recreational marijuana legal in 2016, and this law won’t go into effect until 2024, meaning there was an eight year gap in the legislation. Regardless, this may serve as the beginning of a pattern, pointing to what Minnesota may do down the line. 

In 2020 New Jersey passed a law legalizing recreational marijuana use which went into effect in April of this year. Similarly to California, part of the law protects workers from being discriminated against because of their marijuana use outside of work. However, Walmart and Sam’s Club have continued to administer drug tests to job applicants to search for traces of marijuana, a practice that has gotten them into legal trouble in New Jersey. Walmart is arguing that only the state Cannabis Regulatory Commission can enforce the new employment law, and that this case should be dismissed because it was brought by individuals. Courts in other states in which similar laws have been passed have issued decisions that oppose Walmart’s position, ruling that individual workers can sue under the law. It seems that Minnesota is not the only state that has enacted fuzzy recreational drug use laws that directly affect employers and employees. 

On the bright side of this employment confusion, many appreciate the baby step the Minnesota legislature has taken to legalize marijuana use. The state has been in dire need of updated marijuana legislation, and the hope is that continuing this legalization process will lessen the disparities between black and white arrests for marijuana possession. This change is necessary, because as of 2020 Minnesota was found to rank 8th in the United States for largest racial disparities in marijuana possession arrests. In 2021, the Minnesota Bureau of Criminal Apprehension released data showing that out of the over 6,000 marijuana related arrests made in the state, 90% were for simple possession charges, and a black person was almost five times more likely to be arrested for these types of charges than a white person. This statistic is down from almost eight times more likely back in 2010, but is still extremely present. 

In Conclusion

President Biden’s pardon is just a beginning step towards moving the US forward on marijuana legislation. Though states such as Minnesota are moving in the right direction by gradually legalizing recreational marijuana use, the laws are often unclear and lead to a multitude of logistical issues like those seen in the employment sector. Regardless, making continued progress is important to the U.S. for many reasons and is crucial for helping to lessen racial arrest disparities. Hopefully this pardon will have the effect the administration aimed for and will encourage more state legislatures to update their policies on marijuana usage.

 

 

Meta Faces Class Action Lawsuits Over Pixel Tool Data Controversy

October 22, 2022
Cyber Security, Data, Food and Drug Law, Health Law, Internet, Litigation, Privacy, Social Media

Ray Mestad, MJLST Staffer

With a market capitalization of $341 billion, Meta Platforms is one of the most valuable companies in the world.[1] Information is a prized asset for Meta, but how that information is acquired continues to be a source of conflict. Their Meta “Pixel” tool is a piece of code that allows websites to track visitor activity.[2] However, what Meta does with the data after it is acquired may be in violation of a variety of privacy laws. Because of that, Meta is now facing almost fifty class action lawsuits due to Pixel’s use of data from video players and healthcare patient portals.[3]

What is Pixel?

Pixel is an analytical tool that tracks visitor actions on a website.[4] In theory, the actions that are tracked include purchases, registrations, cart additions, searches and more. This information can then be used by the website owners to better understand user behavior. Website owners can more efficiently use ad spend by tailoring ads to relevant users and finding more receptive users based on Pixel’s analysis.[5]

In the world of search engine optimization and web analysis tools like Pixel are common, and there are other sites, like Google Analytics, that provide similar functions. However, there are two key differences between these other tools and Pixel. First, Pixel has in some cases accidentally scraped private, identifiable information from websites. Second, Pixel can connect that information to the social profiles on their flagship website, Facebook. Whether intentionally or accidentally, Pixel has been found to have grabbed personal information beyond the simple user web actions it was supposed to be limited to and connected them to Facebook profiles.[6]

Pixel and Patient Healthcare Information

It’s estimated that, until recently, one third of the top 100 hospitals in the country used Pixel on their websites.[7] However, that number may decrease after Meta’s recent data privacy issues. Meta faced both criticism and legal action in the summer of 2022 for its treatment of user data on healthcare websites. Pixel incorrectly retrieved private patient information, including names, conditions, email addresses and more. Meta then targeted hospital website users with ads on Facebook, using the information Pixel collected from hospital websites and patient portals by matching user information with their Facebook accounts.[8] Novant Health, a healthcare provider, ran advertisements promoting vaccinations in 2020. They then added Pixel code to their website to evaluate the effectiveness of the campaign. Pixel proceeded to send private and identifiable user information to Meta.[9] Another hospital (and Meta’s co-defendant in the lawsuit), the University of California San Francisco and Dignity Health (“UCSF”), was accused of illegally gathering patient information via Pixel code on their patient portal. Private medical information was then distributed to Meta. At some point, it is claimed that pharmaceutical companies then gained access to this medical information and sent out targeted ads based thereon.[10] That is just one example – all in all, more than 1 million patients have been affected by this Pixel breach.[11] 

Pixel and Video Tracking

The problems did not stop there. Following its patient portal controversy, Meta again faced criticism for obtaining protected user data with Pixel, this time in the context of video consumption. There are currently 47 proposed class actions against Meta for violations of the Video Privacy Protection Act (the “VPPA”). The VPPA was created in the 1980’s to cover videotape and audio-visual materials. No longer confined to the rental store, the VPPA has now taken on a much broader meaning after the growth of the internet. 

These class actions accuse Meta of using the Pixel tool to take video user data from a variety of company websites, including the NFL, NPR, the Boston Globe, Bloomberg Law and many more. The classes allege that by collecting video viewing activity in a personally identifiable manner without consent (matching Facebook user IDs to the activity rather than anonymously), so Pixel users could target their ads at the viewers, Pixel violated the VPPA. Under the VPPA Meta is not the defendant in these lawsuits, but rather the companies that shared user information with Meta.[12]

Causes of Action

The relatively new area of data privacy is scarcely litigated by the federal government due to the lack of statutes protecting consumer privacy on the federal level. Because of that, the number of data protection civil litigants can be expected to continue to grow. [13] HIPAA is the Health Insurance Portability and Accountability Act, an act created in 1996 to protect patient information from disclosure without patient consent. In the patient portal cases, HIPAA actions would have to be initiated by the US government. Claimants are therefore suing Meta under consumer protection and other privacy laws like the California Confidentiality of Medical Information Act, the Federal Wiretap Act, and the Comprehensive Computer Data Access and Fraud Act instead.[14] These state Acts allow individuals to sue, when under Federal Acts like HIPPA, the Government may move slowly, or not at all. And in the cases of video tracking, the litigants may only sue the video provider, not Meta itself.[15] Despite that wrinkle of benefit to Meta, their involvement in more privacy disputes is not ideal for the tech giant as it may hurt the trustworthiness of Meta Platforms in the eyes of the public.

Possible Outcomes

If found liable, the VPPA violations could result in damages of $2,500 per class member.[16] Punitive damages for the healthcare data breaches could run in the millions as well and would vary state to state due to the variety of acts the claims are brought in violation of.[17] Specifically, in the UCSF data case class members are seeking punitive damages of $5 million.[18] One possible hang-up that may become an issue for claimants are arbitration agreements. If the terms and conditions of either hospital patient portals or video provider websites contain arbitration clauses, litigants may have difficulty overcoming them. On the one hand, these terms and conditions may be binding and force the parties to attend mandatory arbitration meetings. On the other hand, consumer rights attorneys may argue that consent needs to come from forms separate from online user agreements.[19] If more lawsuits emerge due to the actions of Pixel, it is quite possible that companies will move away from the web analytics tools to avoid potential liability. It remains to be seen whether the convenience and utility of Meta Pixel stops being worth the risk the web analytics tools present to websites.

Notes

[1] Meta Nasdaq, https://www.google.com/finance/quote/META:NASDAQ (last visited Oct. 21, 2022).

[2] Meta Pixel, Meta for Developers, https://developers.facebook.com/docs/meta-pixel/.

[3] Sky Witley, Meta Pixel’s Video Tracking Spurs Wave of Data Privacy Suits, (Oct. 13, 2022, 3:55 AM), Bloomberg Law, https://news.bloomberglaw.com/privacy-and-data-security/meta-pixels-video-tracking-spurs-wave-of-consumer-privacy-suits.

[4] Meta Pixel, https://adwisely.com/glossary/meta-pixel/ (last visited Oct. 21, 2022).

[5] Ted Vrountas, What Is the Meta Pixel & What Does It Do?, https://instapage.com/blog/meta-pixel.

[6] Steve Adler, Meta Facing Further Class Action Lawsuit Over Use of Meta Pixel Code on Hospital Websites, HIPPA Journal (Aug. 1, 2022), https://www.hipaajournal.com/meta-facing-further-class-action-lawsuit-over-use-of-meta-pixel-code-on-hospital-websites/.

[7] Id.

[8] Id.

[9] Bill Toulas, Misconfigured Meta Pixel exposed healthcare data of 1.3M patients, Bleeping Computer (Aug. 22, 2022, 2:16 PM), https://www.bleepingcomputer.com/news/security/misconfigured-meta-pixel-exposed-healthcare-data-of-13m-patients/.

[10] Adler, supra note 6.

[11] Toulas, supra note 9.

[12] Witley, supra note 3. 

[13] Id.

[14] Adler, supra note 6.

[15] Witley, supra note 3.

[16] Id. 

[17] Dave Muoio, Northwestern Memorial the latest hit with a class action over Meta’s alleged patient data mining, Fierce Healthcare (Aug. 12, 2022 10:30AM), https://www.fiercehealthcare.com/health-tech/report-third-top-hospitals-websites-collecting-patient-data-facebook.

[18] Id.

[19] Witley, supra note 3.



Xenotransplantation: Ethics and Public Policy Need to Catch Up to the Science

March 5, 2022
Administrative Law, Biotechnology, Discrimination, Ethics, Food and Drug Law, Health Law, Medical Devices, New Technology

Claire Colby, MJLST Staffer

In early January, surgeons at the University of Maryland Medical Center made history by successfully transplanting a genetically altered pig heart to a human recipient, David Bennett.  The achievement represents a major milestone in transplantation. The demand for transplantable organs far outpaces the supply, and xenotransplantation–the implantation of non-human tissue into human recipients–could help bridge this gap. In the U.S. alone, more than 106,000 people are on the waiting list for transplants. Legal and ethical questions remain open about the appropriateness of implementing xenotransplants on a large scale. 

The FDA approved the January transplant through an emergency authorization compassionate use pathway because Bennett likely would have died without this intervention. Larger clinical trials will be needed to generate enough data to show that xenotransplants are safe and effective. The FDA will require these trials to show xenotransplantations are non-inferior to human organ transplants. IRB requirements bar interventions where risk outweighs benefits for patients, but accurately predicting and measuring risk is difficult. 

If xenotransplantation becomes standard clinical practice, animal rights proponents may balk at the idea of raising pigs for organs. Far before that point, pre-clinical trials will make heavy use of animal models. Institutional Animal Care and Use Committees (IACUCs) which oversee animal research in universities and medical entities apply a “much lower ethical standard” for animals than human research subjects. Bioethicists apply a “3R” framework for animal subjects research that stresses replacing animal models, reducing animal testing, and refining their use. Because of the inherent nature of xenotransplantation, applying this framework may be near impossible. Ongoing discussions are needed with relevant stakeholders.  

If both human and animal organs are approved for widespread transplant, but human organs prove superior, new allocation policies are needed to determine who gets what. Organ allocation policy is currently dictated by the Organ Procurement and Transplantation Network (OPTN). As it stands, organ transplantation shows inequality across racial groups and financial status. New allocation policies for organs must not reinforce or worsen these disparities. 

Like all medical interventions, patients must be able to provide informed consent for xenotransplantation. The recipient of the altered pig heart had previously been deemed ineligible for a human heart transplant because his heart failure was poorly managed. Reserving experimental interventions, like xenotransplantations, for the sickest patients raises serious ethical concerns. Are these desperate patients truly able to give meaningful consent? If xenotransplantation becomes a common practice, the traditional model of institutional review boards may need updating. Currently, individual institutions maintain their own IRBs. Xenotransplantation of altered animal organs may involve several sites: procurement of the organ, genetic editing, and transplantation may all take place in different locations. A central IRB for xenotransplantation could standardize and streamline this process. 

In all, xenotransplantation represents an exciting new frontier in transplant medicine. Responsibly implementing this innovation will require foresight and parallel innovation in ethics and public policy. 

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