Regulatory

Save the Children . . . From Algorithms?

March 29, 2022
Constitutional Law, Data, Data Privacy, First Amendment, Internet, Regulatory, Social Media

Sarah Nelson, MJLST Staffer

Last week, a bill advanced out of the Minnesota House Commerce Finance and Policy Committee that would ban social media platforms from utilizing algorithms to suggest content to those under the age of 18. Under the bill, known as HF 3724, social media platforms with more than one million account holders that operate in Minnesota, like Instagram, Facebook, and TikTok, would no longer be able to use their algorithms to recommend user-generated content to minors.

The sponsor of the bill, Representative Kristin Robbins, a Republican from Maple Grove, said that she was motivated to sponsor HF 3724 after reading two articles from the Wall Street Journal. In the first, the Wall Street Journal created dozens of automated accounts on the app TikTok, which it registered as being between the ages of 13 and 15. The outlet then detailed how the TikTok algorithm, used to create a user’s For You feed, would inundate teenage users with sex- and drug-related content if they engaged with that content. Similarly, in the second article, the Wall Street Journal found that TikTok would repeatedly present teenagers with extreme weight loss and pro-eating disorder videos if they continued to interact with that content.

In response to the second article, TikTok said it would alter its For You algorithm “to avoid showing users too much of the same content.” It is also important to note that per TikTok’s terms of service, to use the platform, users must be over 13 and must have parental consent if they are under 18. TikTok also already prohibits “sexually explicit material” and works to remove pro-eating disorder content from the app while providing a link to the National Eating Disorders Association helpline.

As to enforcement, HF 3724 says social media platforms are liable to account holders if the account holder “received user-created content through a social media algorithm while the individual account holder was under the age of 18” and the social media platform “knew or had reason to know that the individual account holder was under the age of 18.” Social media platforms would then be “liable for damages and a civil penalty of $1,000 for each violation.” However, the bill provides an exception for content “that is created by a federal, state, or local government or by a public or private school, college, or university.”

According to an article written on the bill by the legislature, Robbins is hopeful that HF 3724 “could be a model for the rest of the country.”

Opposition from Tech

As TechDirt points out, algorithms are useful; they help separate relevant content from irrelevant content, which optimizes use of the platform and stops users from being overwhelmed. The bill would essentially stop young users from reaping the benefits of smarter technology.

A similar argument was raised by NetChoice, which expressed concerns that HF 3724 “removes the access to beneficial technologies from young people.” According to NetChoice, the definition of “social media” used in the bill is unacceptably broad and would rope in sites that teenagers use “for research and education.” For example, NetChoice cites to teenagers no longer being able to get book recommendations from the algorithm on Goodreads or additional article recommendations on a research topic from an online newspaper.

NetChoice also argues that HF 3724 needlessly involves the state in a matter that should be left to the discretion of parents. NetChoice explains that parents, likely knowing their child best, can decide on an individual basis whether they want their children on a particular social media platform.

Opponents of the bill also emphasize that complying with HF 3724 would prove difficult for social media companies, who would essentially have to have separate platforms with no algorithmic functions for those under 18. Additionally, in order to comply with the bill, social media platforms would have to collect more personal data from users, including age and location. Finally, opponents have also noted that some platforms actually use algorithms to present appropriatecontent to minors. Similarly, TikTok has begun utilizing its algorithms to remove videos that violate platform rules.

What About the First Amendment?

In its letter to the Minnesota House Commerce Committee, NetChoice said that HF 3724 would be found to violate the First Amendment. NetChoice argued that “multiple court cases have held that the distribution of speech, including by algorithms such as those used by search engines, are protected by the First Amendment” and that HF 3724 would be struck down if passed because it “result[s] in the government restraining the distribution of speech by platforms and Minnesotans access to information.”

NetChoice also cited to Ashcroft v. ACLU, a case in which “the Supreme Court struck down a federal law that attempted to prevent the posting of content harmful to teenagers on the web due to [the fact it was so broad it limited adult access] as well as the harm and chilling effect that the associated fines could have on legal protected speech.”

As Ars Technica notes, federal courts blocked laws pertaining to social media in both Texas and Florida last year. Both laws were challenged for violating the First Amendment.

Moving Forward

HF 3724 advanced unanimously out of the House Judiciary Finance and Civil Law Committee on March 22. The committee made some changes to the bill, specifying that the legislation would not impact algorithms associated with email and internet search providers. Additionally, the committee addressed a criticism by the bill’s opponents and exempted algorithms used to filter out age-inappropriate content. There is also a companion bill to HF 3724, SF3922, being considered in the Senate.

It will be interesting to see if legislators are dissuaded from voting for HF 3724 given its uncertain constitutionality and potential impact on those under the age of 18, who will no longer be able to use the optimized and personalized versions of social media platforms. However, so far, to legislators, technology companies have not put their best foot forward, as they have sent lobbyists in their stead to advocate against the bill.

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, Medical Devices, New Technology, Regulatory

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.

Hydrogen – The Fuel of the Future?

March 5, 2022
Climate Change, Energy Law, Environmental Law, Regulatory

Max Meyer, MJLST Staffer

Hydrogen is viewed by many as being a key part of reducing global greenhouse gas emissions. Recently, a bipartisan group of lawmakers expressed interest in hydrogen and want to support its adoption in the United States. When used as a fuel source, hydrogen produces only water and heat. It could potentially be used to power cars, trucks, and airplanes and generate electricity. Hydrogen is used on a fairly minimal scale today, but entities ranging from industry to government are increasing investment in the technology. Currently, hydrogen is regulated by a variety of federal agencies, but no comprehensive regulatory scheme exists.

Hydrogen Production

Hydrogen is one of the most abundant elements on earth, but it only exists in compound form with other elements. Hydrogen has the highest fuel content of any fuel by weight.

Hydrogen can be separated from compounds in a few different ways. It can be produced from steam-methane reforming which accounts for 95% of hydrogen production in the U.S. In this process, “natural gas (which is mostly methane) reacts with high pressure, high temperature steam in the presence of a catalyst to produce a mixture of mostly hydrogen and carbon monoxide.” The product stream is then processed further to produce a stream of mostly hydrogen. Water can be added to this mixture to convert the carbon monoxide into carbon dioxide. If the carbon dioxide is subsequently capture and stored underground, the hydrogen produced is referred to as blue hydrogen. If the carbon dioxide is not captured, the hydrogen is called grey hydrogen.

Hydrogen can also be produced from water by electrolysis which splits water molecules into pure hydrogen and oxygen using electricity. When renewable energy is used for electrolysis the resulting hydrogen is often referred to as green hydrogen.

Why Is It Important?

Using fuel cells, hydrogen can produce electricity. A fuel cell contains two electrodes, one negative and one positive, with an electrolyte in the middle. Hydrogen is fed into the negative electrode and air is fed into the positive end. At the negative end, a catalyst separates the hydrogen molecules into protons and electrons. To produce electricity, the electrons go through an external circuit before entering the positive electrode. Then, the protons, electrons, oxygen unite to produce water and heat. Fuel cells can be used in a number of applications ranging passenger and commercial vehicles to powering buildings.

Current Regulatory Framework

Hydrogen is regulated by several federal agencies. The Pipeline and Hazardous Materials Safety Administration (PHMSA) regulates hydrogen pipelines. PHMSA’s mission is to “protect people and the environment by advancing the safe transportation of energy and other hazardous materials[.]” Thus, PHMSA’s regulation of hydrogen pipelines is focused on safety. The Occupational Safety and Health Administration (OSHA) regulates hydrogen in workplaces OSHA’s regulation of hydrogen specifically covers the installation of hydrogen systems. The Environmental Protection Agency (EPA) also regulates hydrogen in several ways. Hydrogen is regulated under the EPA’s Mandator Greenhouse Gas Reporting Program, Effluent Standards under the Clean Water Act, and Chemical Accident Prevention program. However, the EPA’s regulation of hydrogen is primarily a result of hydrogen’s relationship to fossil fuels. The regulations are concerned with the production of hydrogen from fossil fuels such as the methane steam reform process outlined above.

The Department of Energy (DOE) has invested in research and development concerning hydrogen. In 2020, the DOE released its Hydrogen Program Plan. The DOE’s program is intended to “research, develop and validate transformational hydrogen and related technologies… and to address institutional and market barriers, to ultimately enable adoption across multiple applications and sectors.”

In 2021, Congress passed an infrastructure bill with $9.5 billion of funding for clean hydrogen initiatives. $8 billion of that funding is directed towards the creation of Regional Clean Hydrogen Hubs across the country to increase the use of hydrogen in the industrial sector. $1 billion is for clean hydrogen electrolysis research to lower costs from producing hydrogen using renewable energy. Finally, $500 million is for Clean Hydrogen Manufacturing and Recycling to “support equipment manufacturing and strong domestic supply chains.”

Regulation in the Future

The federal government currently does not regulate the construction of hydrogen pipelines. Presently, the Federal Energy Regulatory Commission (FERC) under the Natural Gas Act “regulates the siting, construction, and operation of interstate natural gas pipelines.” If Congress were to give FERC this same power for hydrogen pipelines it would allow for national planning of the infrastructure and lead to a comprehensive pipeline network. Recently, members of Congress have considered the regulatory framework covering hydrogen pipelines and if additional authority over these pipelines should be given to FERC or other federal agencies. However, these discussions are still in the preliminary stages.

Hydrogen has the potential to play a large role in the United States’ effort to reduce greenhouse gas emissions. It can be used in a variety of industries including the transportation and industrial sectors. Congress has recognized hydrogen’s importance and must continue to invest in lowering the costs of hydrogen production and building hydrogen infrastructure.

The Mysterious Disappearance of Deference: What Is the Supreme Court’s Current Relationship to Federal Agencies?

February 7, 2022
Administrative Law, Biotechnology, Copyrights, Ethics, Regulatory, Uncategorized

Carly Michaud, MJLST Staffer

The Supreme Court has had no shortage of administrative law cases in the (possibly) final sessions of one of the Court’s administrative law scholars, Justice Stephen Breyer. Yet, Breyer has found himself and his ideological compatriots in the opposition on the topic in which he situates his expertise. In the recent case regarding OSHA’s ability to require COVID-19 vaccines, Breyer’s dissent repeated discusses the proper deference an agency’s determination should be given by the Supreme Court.

Notably absent from the case is any mention of the previous key to the relationship between the courts and federal agencies: Chevron deference. In fact, Chevron U.S.A., Inc. v. National Resources Defense Council, was, (as of a 2014 analysis in the Yale Journal on Regulation) the “Most Cited Supreme Court Administrative Law decision”. While previously considered a niche area, administrative law is now so ubiquitous in practice that as of July 2021, 55 law schools require students take a course in administrative law or one of its mainstays: legislation or statutory interpretation.

In spite of this, Chevron appears nowhere in the discussion of OSHA’s vaccine mandate, nor in the court’s earlier revocation of the CDC’s eviction moratorium. This absence suggests that perhaps this Court has become a body of health experts, relying on their own understanding of COVID-19 to determine whether these agency-created regulations are effective in their mission. Both cases center on whether an agency action to prevent the spread of COVID-19 is within the purview of their empowering statute, and, despite the broad statutory authorities of these agencies to protect the health of Americans, both actions were deemed beyond that authority.

But back to Chevron, has it been abandoned as a standard? Not yet, although there was some discussion of this proposition during the oral argument of American Hospital Association v. Becerra last November. The Court has not released an opinion yet on this case, however the Court of Appeals had previously upheld HHS’s ability to set reembursement rates, per its statutory authority.

In a final thrust of irony, the death knell for Chevron deference may come from a case challenging the very statute and the very agency whose decision-making was at issue in Chevron: the EPA and the Clean Air Act. This is particularly ironic as the EPA administrator whose decision-making was being challenged in Chevron was Anne Gorsuch, the mother of Supreme Court justice and noted antagonist of agency authority: Neil Gorsuch. Yes, in a tale mirroring Hamlet, Neil Gorsuch seems determined to destroy the administrative state that had entangled his mother in various administrative scandals. The latest edition of this showdown between the Gorsuchs and EPA is scheduled for Monday February 28, which will see the Supreme Court hearing arguments in West Virginia v. EPA and its consolidated cases.

This behavior by the Court belies a grave concern both about the continued disempowerment of federal agencies—which have been empowered directly by Congress—at the hands of the unelected judiciary. Further, the most cynical of us may see this as a direct assault on the authority of agencies that some justices may politically disagree with, further disregarding the knowledge of learned experts to push their own political agendas.

Relieving a Pain Management Crisis: How Medical Cannabis May Help the Prescription Opioid Epidemic

November 13, 2021
Administrative Law, Food and Drug Law, Regulatory, Uncategorized

David C. Edholm, MJLST Staffer

“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human . . . drugs.” To no surprise, near the top of the FDA’s list of current priorities is ameliorating the prescription opioid epidemic. More than 14,000 deaths in 2019 are attributed to prescription opioid overdoses. (See fig. 4 of hyperlink). Celebrity opioid overdoses have raised public awareness of the crisis, however, hundreds of millions of opioid prescriptions are written each year to treat “moderate-to-severe” pain. The epidemic continues today, begging the question of whether any reasonable alternatives to prescription opioids exist, perhaps medical cannabis.

California became the first state to legalize medical cannabis through a ballot initiative in 1996; since then, 35 states and four territories followed. Although the Department of Health and Human Services and the FDA have expressed skepticism about safety and efficacy due to a lack of quality research, legalization in a recreational capacity is becoming more popularized. Recent systematic studies on high-potency cannabis products have shown a cause for concern, however, studies on substituting medical cannabis for prescription opioids remain inconclusive, leaving the door open to this future possibility.

In order for medical cannabis to legitimately contend with prescription opioids, quality safety and efficacy data are required. But the public stands by as FDA has yet to approve a medical use and “marihuana” remains a Schedule I controlled substance. 18 U.S.C. § 812(1) (2018). Recent federal efforts push for decriminalization, but historically the federal government has adopted a “hands off” approach, giving states choice on cannabis regulation. There is coast-to-coast differentiation on cannabis legalization with most states permitting medical use and a growing number permitting recreational use, but due to its current state of being under-researched, it is substantially less controversial to leave the political choice for legalization to the states as long as safety and efficacy are opaque.

The benefit of state choice is articulated through efforts from states like California and Minnesota that aid the national effort to clarify safety and efficacy in legitimate ways. California, for example, allows medical and recreational use, as a result providing a vast data cohort. The state senate bill reads, “[i]t is the intent of the legislature that the state commission objective scientific research by . . . the University of California, regarding the safety and efficacy of administering cannabis as part of medical treatment.” Additionally, Minnesota, which permits medical use and submitted a bill for recreational approval now pending in the senate, created a medical cannabis patient registry that accumulates data, generates reports, and submits the reports to legislature and prominent medical journals that are available to the public. These states are among others providing similar efforts.

Medical cannabis may be an alternative for prescription opioids, yet there remain several questions about safety and efficacy that must be answered in order for the FDA to move on any milestone cannabis regulation. It seems that severe risks posed by cannabis are extremely rare, and are not a public health threat requiring immediate attention. Prescription opioids remain standard treatment post-operation or post-physical trauma and are usually prescribed for short-term use, but 20% of post-op patients still use opioids three months after surgery, despite an increased risk of addiction after only a few days of use. It seems the opioid epidemic is here to stay as long as prescribing practices remain the same, at least until an effective alternative arises. Maybe cannabis will be a solution. It depends on the data.

Monumental Tug-of-War: America’s National Monuments May Be the Latest Targets in the Partisan Policy Back-and-Forth

October 19, 2021
Agriculture, Environmental Law, Regulatory, Social Welfare

Douglas Harman, MJLST Staffer

On October 7, 2021, the Biden Administration moved to restore the size and protections of two national monuments in the state of Utah: Bears Ears National Monument and Grand Staircase-Escalante National Monument. This latest action culminates a back-and-forth of the last three presidencies that has drawn national attention. It suggests an emerging pattern of using national monuments as part of a broader legal and political debate over the use of federal lands.

There is a cultural and political split with liberals broadly favoring conservation/preservation of wilderness and Native American heritage sites and conservatives broadly favoring resource extraction and land development. It now seems likely that national monuments, and the underlying law dealing with their creation, will be subject to the same intense partisan tug-of-war as are other federal land use policies.

The Antiquities Act of 1906 and National Monuments

In the early 20th century, Congress passed the Antiquities Act, delegating to the President the power to “declare by public proclamation historic landmarks, historic and prehistoric structures, and other objects of historic or scientific interest [situated on federal lands]…to be national monuments.” Once a monument is established, the antiquities act also provides for its protection, and penalizes anyone who detrimentally interferes with it. Such a grant of power is quite significant, as it allows a President to designate areas for protection without the requirement for an act of Congress, as is needed for national parks. It is also important to note that, although the statute expressly authorizes the creation of national monuments, the statute is silent about the reduction or dissolution of the same. For this reason, there is general consensus that the President lacks granted or implied authority to completely abolish a national monument without congressional approval (though, as discussed below, some Presidents have reduced the sizes of monuments).

Because it allows Presidents a relatively free hand in preserving lands and does not require congressional approval (with some exceptions added later for Wyoming and Alaska), Presidents have used the Antiquities Act quite frequently to designate lands as monuments. As an additional incentive, the Supreme Court has generally held that Presidents have extremely broad discretion when creating national monuments, and that a designation as a monument protects incidental resources needed to maintain the monument. See Cameron v. United States, 252 U.S. 450 (1920); Cappaert v. United States, 426 U.S. 128 (1976). There are currently 129 National Monuments ranging widely in area and character. Though there has been some controversy over creation of monuments in the past, there had been no record of a President unmaking or effectively undercutting a monument made by a predecessor prior to 2017.

Debate remains around whether and to what extent a President can diminish a national monument. Despite Presidents reducing the size of existing monuments in the past (the last President to do so before Trump was Eisenhower), courts have never squarely addressed the issue of whether and how much a President may reduce an already-created National Monument. Additionally courts have not addressed the companion issue of what level of reduction would constitute an effective abolition of the monument, and might therefore exceed a President’s authority under the Antiquities Act.

Clinton/Obama, then Trump, then Biden

President Clinton established Grand Staircase as a National Monument by proclamation in 1996, a move that sparked controversy in Utah, but received relatively little attention overall and was hardly a national issue of concern. Clinton’s Republican successor, George W. Bush, took no action against Grand Staircase in the eight years he was President. Years later, in December of 2016, as negotiations between Native American Nations and Utah fell apart, and with an eye on both his legacy and his successor, President Obama signed a declaration creating Bears Ears National Monument. Environmentalists, Native American Nations, and academic groups hailed Bears Ears as protecting unique habitats, historical areas, and indigenous sacred sites. However, Utah locals and politicians, as well as various resource-extraction industries, derided the creation of Bears Ears as federal government overreach and a denial of resources to the state.

When the Trump Administration took office in 2017, it had a different set of goals for federal lands. In addition to environmental deregulation and increased oil and gas extraction, Trump signed a proclamation in late 2017 to shrink Bears Ears and Grand Staircase. The actions sparked public interest for two reasons. First, because no President since Eisenhower had reduced a national monument, and previous reductions and revisions of boundaries appear to have been relatively non-controversial. Second, because the reduction proclaimed by Trump amounted to the largest reduction of national monument land in US history, reducing Bears Ears by 85% and Grand Staircase by 50%. The action was promptly challenged in court, with plaintiffs arguing that the reduction effectively abolished the monuments, thereby intruding on congressional powers. Wilderness Society v. Trump, 2019 WL 7902967 (Nov. 2019) (trial pleading). There was an additional legal issue regarding Grand Staircase, as Congress statutorily recognized and modified the monument in 1998, raising the question of whether a President could unilaterally further alter a monument with borders designated by Congress. The case dragged on in DC courts and has not yielded a clear resolution as of this writing (and is unlikely to do so, as Trump is no longer President and the proclamation reducing the size of the monuments has now been superseded).

President Trump was defeated in the 2020 election, and Joe Biden became President. One of his myriad goals was to restore environmental protections undone during his predecessor’s term. This included restoring Bears Ears and Grand Staircase to their pre-Trump sizes (in the same proclamation, Biden restored protections to the marine Northeast Canyons and Seamounts National Monument, which Trump had opened to commercial fishing). This has meant that, just like many other land use and environmental priorities, the pendulum has swung on national monuments based solely on the party affiliation of the occupant of the White House.

The Future of National Monuments

In the proclamations restoring the monuments, the Biden Administration took no legal issue with the actions of the Trump Administration. There was no claim that the diminishment had been illegal or unconstitutional; there have been no circulated legal memos denouncing the Trump White House’s legal logic as flawed; and there has been no argument that the reduction exceeded the scope of Presidential power by effectively abolishing the monuments. The reversal of policy has also essentially rendered any court decision of the cases against the Trump administration moot. This means that, although the Biden administration undid Trump’s actions, it appears to have tacitly accepted and affirmed their validity. This means the pattern of the last several years can (and probably will) be repeated.

It does not take a huge logical jump, then, to imagine the national monuments pulled into a perpetual seesaw. Perhaps a Republican takes the White House in 2024 or 2028 and moves to slash the size of national monuments as Trump did, only for them to be re-expanded by a future Democrat. Perpetual change of federal land designation, and, therefore, use, is not good for anyone. Industry will be disincentivized from making investments in development on lands that could be incorporated or re-incorporated into a protected National Monument, while environmental and Native American groups will have to be constantly on the alert for actions from a hostile President unilaterally undoing everything they’ve worked extremely hard to protect on national monument land.

Such a policy seesaw hurts everyone. It seems evident that the unilateral and unlimited Presidential power to create and diminish National Monuments will lead to significant instability as long as the major parties have such diametrically opposed land use goals. One possible solution is for Congress to amend the law, but that seems unlikely given Congress’s declining productivity in the last several years and the political divisions in an evenly split Congress. Without Congressional action, further guidance from the courts about the extent of a President’s legal ability under the Antiquities Act to diminish national monuments may be the only way to stabilize the process. The question is when, and if, the courts will have their chance to weigh in.

You Wouldn’t 3D Print Tylenol, Would You?

October 12, 2021
3-D Printing, Administrative Law, Biotechnology, Ethics, Food and Drug Law, Health, Healthcare, Medical Devices, Pharmaceuticals, Regulatory

By Mason Medeiros, MJLST Staffer

3D printing has the potential to change the medical field. As improvements are made to 3D printing systems and new uses are allocated, medical device manufacturers are using them to improve products and better provide for consumers. This is commonly seen through consumer use of 3D-printed prosthetic limbs and orthopedic implants. Many researchers are also using 3D printing technology to generate organs for transplant surgeries. By utilizing the technology, manufacturers can lower costs while making products tailored to the needs of the consumer. This concept can also be applied to the creation of drugs. By utilizing 3D printing, drug manufacturers and hospitals can generate medication that is tailored to the individual metabolic needs of the consumer, making the medicine safer and more effective. This potential, however, is limited by FDA regulations.

3D-printed drugs have the potential to make pill and tablet-based drugs safer and more effective for consumers. Currently, when a person picks up their prescription the drug comes in a set dose (for example, Tylenol tablets commonly come in doses of 325 or 500 mg per tablet). Because the pills come in these doses, it limits the amount that can be taken to multiples of these numbers. While this will create a safe and effective response in most people, what if your drug metabolism requires a different dose to create maximum effectiveness?

Drug metabolism is the process where drugs are chemically transformed into a substance that is easier to excrete from the body. This process primarily happens in the kidney and is influenced by various factors such as genetics, age, concurrent medications, and certain health conditions. The rate of drug metabolism can have a major impact on the safety and efficacy of drugs. If drugs are metabolized too slowly it can increase the risk of side effects, but if they are metabolized too quickly the drug will not be as effective. 3D printing the drugs can help minimize these problems by printing drugs with doses that match an individual’s metabolic needs, or by printing drugs in structures that affect the speed that the tablet dissolves. These individualized tablets could be printed at the pharmacy and provided straight to the consumer. However, doing so will force pharmacies and drug companies to deal with additional regulatory hurdles.

Pharmacies that 3D print drugs will be forced to comply with Current Good Manufacturing Procedures (CGMPs) as determined by the FDA. See 21 C.F.R. § 211 (2020). CGMPs are designed to ensure that drugs are manufactured safely to protect the health of consumers. Each pharmacy will need to ensure that the printers’ design conforms to the CGMPs, periodically test samples of the drugs for safety and efficacy, and conform to various other regulations. 21 C.F.R. § 211.65, 211.110 (2020). These additional safety precautions will place a larger strain on pharmacies and potentially harm the other services that they provide.

Additionally, the original drug developers will be financially burdened. When pharmacies 3D print the medication, they will become a new manufacturing location. Additionally, utilizing 3D printing technology will lead to a change in the manufacturing process. These changes will require the original drug developer to update their New Drug Application (NDA) that declared the product as safe and effective for use. Updating the NDA will be a costly process that will further be complicated by the vast number of new manufacturing locations that will be present. Because each pharmacy that decides to 3D print the medicine on-site will be a manufacturer, and because it is unlikely that all pharmacies will adopt 3D printing at the same time, drug developers will constantly need to update their NDA to ensure compliance with FDA regulations. Although these regulatory hurdles seem daunting, the FDA can take steps to mitigate the work needed by the pharmacies and manufacturers.

The FDA should implement a regulatory exception for pharmacies that 3D print drugs. The exemption should allow pharmacies to avoid some CGMPs for manufacturing and allow pharmacies to proceed without being registered as a manufacturer for each drug they are printing. One possibility is to categorize 3D-printed drugs as a type of compounded drug. This will allow pharmacies that 3D print drugs to act under section 503A of the Food Drug & Cosmetic Act. Under this section, the pharmacies would not need to comply with CGMPs or premarket approval requirements. The pharmacies, however, will need to comply with the section 503A requirements such as having the printing be performed by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician, limiting the interstate distribution of the drugs to 5%, only printing from bulk drugs manufactured by FDA licensed establishments and only printing drugs “based on the receipt of a valid prescription for an individualized patient”. Although this solution limits the situations where 3D prints drugs can be made, it will allow the pharmacies to avoid the additional time and cost that would otherwise be required while helping ensure the safety of the drugs.

This solution would be beneficial for the pharmacies wishing to 3D print drugs, but it comes with some drawbacks. One of the main drawbacks is that there is no adverse event reporting requirement under section 503A. This will likely make it harder to hold pharmacies accountable for dangerous mistakes. Another issue is that pharmacies registered as an outsourcing facility under section 503B of the FD&C Act will not be able to avoid conforming to CGMPs unless they withdraw their registration. This issue, however, could be solved by an additional exemption from CGMPs for 3D-printed drugs. Even with these drawbacks, including 3D-printed drugs under the definition of compounded drugs proposes a relatively simple way to ease the burden on pharmacies that wish to utilize this new technology.

3D printing drugs has the opportunity to change the medical drug industry. The 3D-printed drugs can be specialized for the individual needs of the patient, making them safer and more effective for each person. For this to occur, however, the FDA needs to create an exemption for these pharmacies by including 3D-printed drugs under the definition of compounded drugs.

You Gotta Fight for Your Right to Repair

April 4, 2021
Business Law, Ethics, Public Health, Regulatory

Christopher Cerny, MJLST Staffer

Last spring, as the first wave of the coronavirus pandemic hit critical heights, many states faced a daunting reality. The demand for ventilators, an “external set of lungs” designed to breathe for a patient too weak or compromised to breathe on their own, skyrocketed. Hospitals across the United States and countries around the globe clamored for more of the life saving devices. In March and April of 2020, the increasing need for this equipment forced doctors in Washington State, New York, Italy, and around the world to make heartbreaking decisions to prioritize the scarce supply. With this emergency equipment operating at maximum capacity, any downtime meant another potential life lost. But biomeds, hospital technicians who maintain these crucial medical devices, were frequently unable to troubleshoot or repair out-of-service ventilators to return them to the frontlines. This failure to fix the much-needed equipment was not due to lack of time or training. Instead, it was because many manufacturers restrict access to repair materials, such as manuals, parts, or diagnostic equipment. According to one survey released in February 2021, 76% of biomeds said that manufacturers denied them access to parts or service manuals in the previous three months and 80% said they have equipment that cannot be serviced due to manufacturers’ restrictions to service keys, parts, or materials.

While the prohibition of repairs of life support equipment highlights the extreme danger this restriction creates, the situation is not unique to hospitals and emergency equipment. As technology becomes increasingly complex and proprietary, all manner of tech manufacturers are erecting more and more barriers that prevent owners and independent repair shops from working on their products. Tesla, for example, is adamant about restricting repairs to its vehicles. The electric vehicle auto maker will not provide parts or authorize repairs if performed at an uncertified, independent repair shop or end user. Tesla has gone so far as to block cars repaired outside of its network from using its Superchargers. Apple historically also prevented end users from performing their own repairs, utilizing specialized tools and restricting access to parts. John Deere requires farmers to comply with a software licensing agreement that is in appearance designed to protect the company’s proprietary software, but in practice prevents farmers from clearing error codes to start their farm equipment without an authorized technician.

In response to these obstructions to repair, the Right to Repair movement solidified around the simple proposition that end users and independent repair shops should be provided the same access to manuals and parts that many tech companies reserve solely to themselves or their subsidiaries. This proposition is catching on and the legislatures in twenty-five states are currently considering thirty-nine bills involving the right to repair. However, of the thirty-nine bills, only three address medical technology with the bulk of the proposals devoted to general consumer products—think appliances, iPads, and smart devices—and farm equipment.

Massachusetts is an early adopter of right to repair laws. Its legislature passed a law in 2012 specific to motor vehicles that, inter alia, standardized diagnostic and service information, mandated its accessibility by owners and independent or third-party repair shops, and established any violation of the provisions of the act as an unfair method of competition and an unfair trade practice. This past November, Massachusetts voters approved a ballot measure that expanded the scope of the 2012 right to repair law and closed a loophole that could circumvent the requirements imposed in the earlier statute. Automakers lobbied in force to oppose the measure, spending in excess of $25 million in advertising and other efforts. Taking into account the money spent by both sides of the ballot measure, the right to repair initiative was the most expensive measure campaign in Massachusetts history. The European Union is also taking steps to broaden access to repair materials and information. The European Parliament passed a resolution aimed at facilitating a circular economy. Acknowledging the finite nature of many of the rare elements used in modern technology, the European Union is aiming to make technology last longer and to create a second-hand market for older models. The resolution expanding repair access is a part of that effort by ensuring the ease of repair to prolong the life of the technology and delay obsolescence.

Some manufacturers are making concessions in the face of the Right to Repair Movement. Apple, notoriously one of the most restrictive manufacturers, did an about face in 2019 and expanded access to “parts, tools, training, repair manuals and diagnostics” for independent repair businesses working on out of warranty iPhones. Tesla opened its repair platform to independent repair shops in the European Union after the EU Commission received complaints, but the access can be prohibitively expensive at €125 per hour for the use of diagnostics and programming software. However, these minimal efforts are stop-gap measures designed to slow the tide of legislation and resolutions aimed at broadening access to the materials needed to perform repairs to break the monopolistic hold manufacturers are trying to exert over routine fixes.

The Right to Repair movement is clearly gaining ground as the implications of this anticompetitive status quo in the repair and second-hand market was brought into stark relief by the strains imposed by the COVID-19 pandemic, which strained not only hospitals but agriculture, infrastructure, and day-to-day life. The impact of these restrictions on independent repair shops, farmers, consumers, patients, and do-it-yourselfers more than ever became an obvious impediment to health, safety, and a less extractive economy. And as shown in Massachusetts, voters are responding by expanding the right to repair, even in the face of expensive lobbying and advertising campaigns. Legislators should continue to bring additional bills, especially addressing the restrictions on repairs of emergency medical equipment and should enact the existing proposals in the twenty-five states currently considering them.

It’s Not Always Greener on the Other Side: Challenges to Environmental Marketing Claims

March 28, 2021
Environmental Law, Regulatory, Telecommunication

Ben Cooper, MJLST Staffer

On March 16, 2021 a trio of environmental groups filed an FTC complaint against Chevron alleging that Chevron violated the FTC’s Green Guides by falsely claiming “investment in renewable energy and [Chevron’s] commitment to reducing fossil fuel pollution.” The groups claim that this complaint is the first to use the Green Guides to prevent companies from making misleading environmental claims. Public attention has supported companies that minimize their environmental impact, but this FTC complaint suggests that a critical regulatory eye might be in the future. If the environmental groups convince the FTC to enforce the Green Guides against Chevron, other companies should review the claims they make about their products and operations.

A Morning Consult poll released in early December 2020 showed that nearly half of U.S. adults supported expanding the use of carbon removal practices and technologies. Only six percent of survey respondents opposed carbon removal practices. In response to the overwhelming public support for carbon reduction, hundreds of major companies are making some type of commitment to reduce their carbon footprint and curb climate change. One popular program, the Science Based Targets initiative, has over 1,200 participants who made various pledges to decarbonize (or offset the carbon within) their operations.

International and non-governmental organizations took the reins of climate change policy, especially once the Trump Administration withdrew the United States from the Paris Agreement in 2017. “Climate change seems to be the leading fashion statement for business in 2019,” declared a Marketplace story in October of 2019. Yet, as with fashion, style only gets one so far. Substance is key—and often lacking. One of the founders of the Science Based Targets initiative criticized fashionable but flimsy voluntary corporate commitments: “[T]here is not a lot of substance behind those [voluntary corporate] commitments or the commitments are not comprehensive enough.”

The voluntary commitments placated environmental groups when the alternative was the Trump Administration’s silence—but the Biden Administration presents an eager environmental partner: the FTC complaint “is the first test to see if [the Biden Administration] will follow through with their commitment to hold big polluters accountable,” said an environmental group spokesperson according to a Reuters report. The consensus of environmental groups, industry commentators, and regulatory observers appears to be that government oversight is imminent to encourage consistency and accountability—and to avoid “greenwashing.”

Should organizations that make environmental claims be concerned about enforcement action? It is too early to tell if the Chevron FTC complaint portends future complaints. In the Green Guides, the FTC declared that it seeks to avoid placing “the FTC in the inappropriate role of setting environmental policy,” which might suggest that it will stick to questions of misrepresentation and avoid wading into questions of evaluating environmental claims. It is also worth noting that the FTC is missing one of its five commissioners and Commissioner Rohit Chopra is expected to resign in anticipation of his nomination to head the Consumer Financial Protection Bureau. While the FTC might not be in a position at the moment to enforce the Green Guides, organizations that make environmental claims in marketing materials should monitor this complaint and ensure their compliance with FTC guidance as well as any policy changes from the Biden Administration.

Clawing Back the “Jackpot” Won During the Texas Blackouts

March 28, 2021
Economics, Energy Law, Regulatory

Isaac Foote, MJLST Staffer

For most Texans, the winter storm in February 2021 meant cold temperatures, uncertain electricity at best, and prolonged blackouts at worst. For some energy companies, however, it was like “hitting the jackpot.” We here at MJLST (in Madeline Vavricek’s excellent piece) have already discussed the numerous historical factors that made Texas’s power system so vulnerable to this storm, but in the month after power was restored to customers, a new challenge has emerged for regulators to address: who will pay the estimated $50 billion in electricity transactions carried out during the week of blackouts. A number estimated to eclipse the total sales on the system over the previous three years!

At the highest level, the Texas blackouts were a result of the electric grid’s need to be ‘balanced’ in real time, i.e. always have sufficient electricity supply to meet demand. As the winter storm hit Texas, consumers increased demand for electricity, as they turned up electric heaters, while simultaneously a lack of winterization drove natural gas, wind, and nuclear electricity producers offline. So, to “avoid a catastrophic failure that could have left Texans in the dark for months,” Texas grid operator, the Electric Reliability Council of Texas (ERCOT), needed to find a way to drastically increase electricity supply and reduce electricity demand. Blackouts were the tool-of-last-resort to cut demand, but ERCOT also attempted to increase supply through authorizing an extremely high wholesale price of electricity. Specifically, ERCOT and the Texas Public Utility Commission (PUC) authorized a price of $9,000 per megawatt hour (MWh), over 340 times the annual average price of $26/MWh.

These high prices may have kept some additional generation online, but they also resulted in devastating impacts for consumers (especially those using the electric provider Griddy) and electric distributors (like Brazos Electric Power Cooperative that has already filed for Chapter 11 bankruptcy protection). Now, the Independent Market Monitor (IMM)for the PUC is questioning whether the $9,000/MWh electricity price was maintained for too long after the storm hit: specifically, the 32 hours following the end of controlled blackouts between February 17th and 19th. The IMM claims that the decision to delay reducing the price of electricity “resulted in $16 billion in additional costs to ERCOT’s market” that will eventually need to be recovered from consumers.

The IMM report on the issue has created a showdown in Texas Government between the State Senate, House, and the PUC. Former Chair of the PUC, Arthur D’Andrea, argued against repricing as “it’s just nearly impossible to unscramble this sort of egg,” while the State Senate passed a bill that would require ERCOT to claw back between $4.2 billion and $5.1 billion in from generators for the inflated prices. D’Andrea’s opposition to the clawback has already resulted in his resignation, but it appears unlikely this conflict will be resolved as the State House may concur with the PUC’s position.

There is further confusion over whether such a clawback would be legal in the first place. Before his resignation, D’Andrea implied such a clawback was beyond the power of the PUC. However, Texas Attorney General Ken Paxton issued an opinion that: “the Public Utility Commission has complete authority to act to ensure that ERCOT has accurately accounted for electricity production and delivery among market participants in the region. Such authority likely could be interpreted to allow the Public Utility Commission to order ERCOT to correct prices for wholesale electricity and ancillary services during a specific timeframe . . . provided that such regulatory action furthers a compelling public interest.”

Going forward it appears that the Texas energy industry will be facing a wave of lawsuits and bankruptcies, whatever the decisions made by the PUC or legislators. However, it is important to remember that someone will end up bearing responsibility for the billions of dollars in costs incurred during the crisis. While most consumers will not see this directly on their electricity bill, like those using Griddy had the misfortune to experience, these costs will eventually be transferred onto consumers in some ways. Managing this process in conjunction with rebuilding a more resilient energy system will be a challenge that Texas energy system stakeholders, policymakers, and regulators will have to take on.

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