Food and Drug

COVID-19 Vaccination: Pervasive Skepticism and Employer Mandates in the United States

December 6, 2020
COVID-19, Employment, Food and Drug, Public Health

Drew Miller, MJLST Staffer

On December 31, 2019, the COVID-19 pandemic began when the World Health Organization’s (WHO) Chinese office picked up a media statement by the Wuhan Municipal Health Commission regarding cases of “viral pneumonia.” Nearly a year later, despite the protective measures instituted on a global scale to slow the spread, COVID-19 has claimed the lives of nearly 1,500,000 people worldwide) and shows no sign of slowing down. All hope is not lost; scientists and biopharmaceutical companies have worked diligently throughout the crisis, and a large-scale vaccination release seems imminent. However, given the prevalence of anti-vaccination sentiment in the United States, it may be difficult to distribute the vaccine to enough people; employer-mandated vaccines likely offer the best chance for widespread vaccination, but the standards governing such mandates remain unclear.

Anti-Vaccination Sentiment in the US

Whether the vaccine will provide outright immunity or simply partial protection, it will regardless be a critical step toward ending the pandemic. However, vaccines are obviously only effective if people agree to get the shot, and that may prove to be a significant barrier in the United States. Vaccine doubt and anti-vaccination movements continue to grow in popularity for a variety of reasons. Social media’s unique ability to bring together like-minded individuals across the globe inevitably results in the creation of insular groups; anti-vaccine support from celebrities such as Jenny McCarthy and Jim Carrey provide a degree of validation to “regular” people who feel the same way; and general government distrust, which has sharpened considerably under the tumultuous and polarizing Trump presidency, heightens suspicions surrounding FDA testing and approval processes. Finally, as noted by Dr. Paul A. Offit, an infectious disease expert and co-inventor of a vaccine for rotavirus, “Vaccines are a victim of their own success. We have largely eliminated the memory of many diseases.”

Moreover, skepticism regarding the safety and efficacy coronavirus vaccine is not entirely unfounded. The vaccine development process typically takes a decade, whereas this one began under a year ago. A group of researchers at the Johns Hopkins Center for Health Security and the Texas State University anthropology department writes, “If poorly designed and executed, a COVID-19 vaccination campaign in the U.S. could undermine the increasingly tenuous belief in vaccines and the public health authorities that recommend them – especially among people most at risk of COVID-19 impacts.” The results of a poll conducted by Pew Research Center in September indicates the consequences of all these factors: just over half (51%) of U.S. adults definitely or probably would get a COVID-19 vaccine if it were available today—a 21% drop from 72% in May.

Employer-Mandated Vaccines

With skepticism at an all-time high, the responsibility for raising vaccination rates in the U.S. may fall to employers. The U.S. Occupational Safety and Health Administration (OSHA) allows employers to legally impose an influenza vaccine requirement on their workers, but there are several requirements and exceptions that make such a mandate more difficult to impose.

First, employees are entitled under the Americans with Disabilities Act (ADA) to request medical and disability exemptions. This exemption requires proof of an underlying disability or medical condition that renders an employee essentially unable to safely get the vaccine. Second, employees may also claim religious exemptions to avoid an employer-mandated vaccine. However, Title VII of the Civil Rights Act of 1964 states that an employee must have a “sincerely held religious belief” against vaccination. In 2020, the Third Circuit Court of Appeals held that an employee’s “holistic health lifestyle” and personal belief that vaccines are harmful were insufficient to trigger protection under the Civil Rights Act. See Brown v. Children’s Hosp. of Philadelphia, 794 Fed. Appx. 226 (3rd Cir. 2020). The court wrote, “[I]t is not sufficient merely to hold a ‘sincere opposition to vaccination’; rather, the individual must show that the ‘opposition to vaccination is a religious belief.’” Id. (citing Fallon v. Mercy Catholic Med. Ctr. of Southeast Pa., 877 F.3d 487, 490 (3rd Cir. 2017)).

There are two primary standards governing the situations in which employers may legally require vaccinations regardless of religious or medical exemptions. Title VII does not require employers to make “reasonable accommodations” for medical or religious reasons if it would pose an undue hardship, which it defines as “more than de minimis cost” to the operation of the business. The ADA standard is stricter, requiring reasonable accommodation barring undue hardship, which it defines as an “action requiring significant difficulty or expense.”

Finally, because vaccinations are “medical examinations” under the ADA, the COVID-19 vaccine would need to be deemed “job-related, consistent with business necessity or justified by a direct threat, and no broader or more intrusive than necessary.” Although the Equal Employment Opportunity Commission (EEOC), which is responsible for enforcing federal anti-discrimination laws in employment, has labeled COVID-19 as a “direct threat” to the workplace and stated that employers are allowed under the ADA to “bar an employee from physical presence in the workplace if he refuses to have his temperature taken or refuses to answer questions about whether he has COVID-19, has symptoms associated with COVID-19, or has been tested for COVID-19,” it has not yet stated whether employers will have the right to make a vaccine mandatory.

Conclusion

As such, the rights of employers to legally impose COVID-19 vaccination requirements on employees are uncertain and, absent clear direction or regulation, will likely require case-by-case analysis to determine the validity of each exemption and the corresponding hardship to business. Consequently, even if employers do have the legal right, protracted legal battles are the only remedy, and given the pervasive fear of vaccinations in today’s social climate, there are likely to be a great many of them. Meanwhile, the COVID-19 pandemic will continue to ravage the nation.

FDA Approval of a SARS-CoV-2 Vaccine and Surrogate Endpoints

November 1, 2020
COVID-19, Food and Drug, Health, Healthcare, Public Health

Daniel Walsh, Ph.D, MJLST Staffer

The emergence of the SARS-CoV-2 virus has thrown the world into chaos, taking the lives of more than a million worldwide to date. Infection with SARS-CoV-2 causes the disease COVID-19, which can have severe health consequences even for those that do not succumb. An unprecedented number of vaccines are under development to address this challenge. The goal for any vaccine is sterilizing immunity, which means viral infection is outright prevented. However, a vaccine that provides only partially protective immunity will still be a useful tool in fighting the virus. Either outcome would reduce the ability of the virus to spread, and hopefully reduce the incidence of severe disease in those who catch the virus. An effective vaccine is our best shot at ending the pandemic quickly.

For any vaccine to become widely available in the United States, it must first gain approval from the Food and Drug Administration (FDA). Under normal circumstances a sponsor (drug manufacturer) seeking regulatory approval would submit an Investigational New Drug (IND) application, perform clinical trials to gather data on safety and efficacy, and finally file a Biologics License Application (BLA) if the trials were successful. The FDA will review the clinical trial data and make a determination as to whether the benefits of the therapy outweigh the risks, and if appropriate, approve the BLA. Of course, degree of morbidity and mortality being caused by COVID-19 places regulators in a challenging position. If certain prerequisites are met, the FDA as the authority to approve a vaccine using an Emergency Use Authorization (EUA). As pertaining to safety and efficacy, the statutory requirements for issuing an EUA are lower than normal approval. It should also be noted that an initial approval via EUA does not preclude eventual normal approval.  Full approval of the antiviral drug remdisivir is an example of this occurrence.

In any specific instance, the FDA must conclude that a reason for using the EUA process (in this case SARS-CoV-2):

can cause a serious or life-threatening disease or condition . . . based on the totality of scientific evidence available . . . including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that . . . the product may be effective in diagnosing, treating, or preventing [SARS-CoV-2] . . . the known and potential benefits of the product, when used to diagnose, prevent, or treat [SARS-CoV-2], outweigh the known and potential risks of the product . . . .

21 USC 360bbb-3(c). On its face, this statute does not require the FDA to adhere to the full phased clinical trial protocol in grating an EUA approval. Of course, the FDA is free to ask for more than the bare minimum, and it has wisely done so by issuing a set of guidance documents in June and October. The FDA indicated that, at the minimum, a sponsor would need to supply an “interim analysis of a clinical endpoint from a phase 3 efficacy study;” that the vaccine should demonstrate an efficacy of at least 50% in a placebo controlled trial; that phase 1 and 2 safety data should be provided; and that the phase 3 data “should include a median follow-up duration of at least two months after completion of the full vaccination regimen” (among other requirements) in the October guidance.

It is clear from these requirements that the FDA is still requiring sponsors to undertake phase 1, 2, and 3 trials before FDA will consider issuing an EUA, but that the FDA is not going to wait for the trials to reach long term safety and efficacy endpoints, in an effort to get the public access to a vaccine in a reasonable time frame. The Moderna vaccine trial protocol, for example, has a study period of over two years. The FDA also has a statutory obligation to “efficiently review[] clinical research and take[] appropriate action . . . in a timely manner.” 21 USC § 393(b)(1).

One method of speeding up the FDA’s assessment of efficacy is a surrogate endpoint. Surrogate endpoints allow the FDA to look at an earlier, predictive metric of efficacy in a clinical trial when it would be impractical or unethical to follow the trial to its actual clinical endpoint. For example, we often use blood pressure as a surrogate endpoint when evaluating drugs intended to treat stroke. The FDA draws a distinction between candidate, reasonably likely, and validated surrogate endpoints. The latter two can be used to expedite approval. However, in its June guidance, the FDA noted “[t]here are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine . . . .  [and sponsors should therefore] pursue traditional approval via direct evidence of vaccine safety and efficacy . . . .” This makes it unlikely surrogate endpoints will play any role in the initial EUAs or BLAs for any SARS-CoV-2 vaccine.

However, as the science around the virus develops the FDA might adopt a surrogate endpoint as it has for many other infectious diseases. Looking through this list of surrogate endpoints, a trend is clear. For vaccines, the FDA has always used antibodies as a surrogate endpoint. However, the durability of the antibody response to SARS-CoV-2 has been an object of much concern. While this concern is likely somewhat overstated (it is normal for antibody levels to fall after an infection is cleared), there is evidence that T-cells are long lasting after infection with SARS-CoV-1, and likely play an important role in immunity to SARS-CoV-2. It is important to note that T-Cells (which coordinate the immune response and some of which can kill virally infected cells) and B-Cells (which produce antibody proteins) are both fundamental, and interdependent pieces of the immune system. With this in mind, when developing surrogate endpoints for SARS-CoV-2 the FDA should consider whether it is open to a more diverse set of surrogate endpoints in the future, and if so, the FDA should communicate this to sponsors so they can begin to build the infrastructure necessary to collect the data to ensure vaccines can be approved quickly.

 

Can the Legal System Help Combat COVID-19

March 25, 2020
Food and Drug, Health, Public Health

Amanda Jackson, MJLST Staffer

As the novel coronavirus, COVID-19, continues its global rampage, the United States has been hard hit.  Now third with respect to number of new cases, there is little evidence to show that the case count will decrease any time soon.  If Italy provides any indication of what is to come, the United States is only going to be hit harder by the life-threatening virus.  Both federal government and local governments have taken drastic measures to combat the spread of COVID-19, including state-wide shelter-in-place orders, closing schools and universities, banning dining in at bars and restaurants, and moving non-essential businesses to work-from-home models.

As the confirmed cases continue to rise, so does uncertainty and uneasiness among the nation and the world as a whole.  What will fix this crisis?  How long will these measures be in place?  How many more people will get sick and potentially pass away from the virus?  What will happen to the economy?  Will my loved ones be okay?  The questions never seem to end.  Luckily, however, there are some answers as to how different laws, administrative agencies, and regulations in place in the United States can aid in the fight against the quickly spreading coronavirus.

First, the Defense Production Act (DPA) can alleviate shortages in medical equipment.  As concern about the novel virus itself grows, concern for the availability of necessary supplies and equipment also seems to grow at record speeds.  A lack of masks and other personal protective equipment for healthcare workers, a shortage in ventilators and beds for sick patients, and even a need for healthcare workers and hospital space are becoming more prevalent as the COVID-19 crisis continues.   The DPA, a Korean War-era law, enables the federal government to require private companies to provide for the needs of national defense.  The DPA may not be able to satisfy the need for healthcare workers and hospital space, but it can allow the federal government to direct manufacturers to produce the desperately needed medical equipment for healthcare workers and patients.  However, the President must invoke the DPA in order for it to make a difference, and as of right now, the DPA has not been invoked to aid in the fight against coronavirus.  Although some companies have increased or altered production to help restock the necessary equipment, it remains unclear whether that alone, without invoking the DPA, will be enough to meet the needs of the United States in the coming weeks.  Even so, the DPA provides a robust option to fulfill the needs of the nation in the fight against the pandemic.

Second, the Federal Drug Administration’s (FDA) and the National Institute of Health’s (NIH) ability to fast track vaccines and therapeutic drugs can speed up development of a COVID-19 vaccine or therapy.  Called an Emergency Use Authorization (EUA), the FDA is able to authorize emergency use of an unapproved product or an unapproved use of an approved product under a declaration of a public health, domestic, or military emergency, or a material threat.  The evidence required for approval of an EUA is that the product “may be effective” to treat, diagnose, or prevent the conditions associated with the declaration.  This is a lower standard than the “effectiveness” standard used for typical FDA approvals, a process that takes on average twelve years to go from a new drug in a laboratory to a drug on a pharmacy shelf.  In determining whether to approve the EUA, the Commissioner has to determine that the known and potential benefits of the product outweigh the risks associated with the product, while also considering the threat prompting the emergency declaration.  Fortunately, the FDA has already issued multiple EUAs with respect to the novel coronavirus, such as for tests to detect COVID-19.  The FDA has also instituted flexible measures outside of EUAs that enable states to take a more prominent role than typically allowed.  For example, the FDA is now allowing states to approve COVID-19 tests without requiring FDA approval or an EUA.  Moreover, NIH is also fast-tracking development of a coronavirus vaccine, with a Phase I clinical trial of the vaccine candidate having already begun.

Third, declarations of major disaster areas will open up emergency funds to help states and local governments respond to an outbreak.  Major disaster area declarations are often requested when a disaster exceeds the response capabilities of state and local governments under extremely severe circumstances.  Major disaster area declarations enable a wide range of federal assistance for both individuals and public infrastructure.  With respect to coronavirus, the President has already declared New York and other hard-hit states as major disaster areas, the first time in United States history that a major disaster has been declared for a public health threat.  The declaration enables the federal government to pay for a majority of the states’ costs and mobilize the Federal Emergency Management Agency (FEMA) to deploy assistance in the state, among other methods of assistance.

Fourth, shelter-in-place orders by local governments may reduce the spread of the virus.  Shelter-in-place orders mandate that residents stay in their homes, except for essential trips (e.g., to the grocery store or a pharmacy).  Many shelter-in-place orders also force all non-essential businesses to close.  These orders are generally constitutional under a state’s police power.  At least eight states and many cities have issued shelter-in-place orders as a means to flatten the curve and reduce the impact of coronavirus on society and the healthcare system.  Some law enforcement officials appear to be taking the orders very seriously, breaking up parties in violation of the shelter-in-place rules or stating that the orders will be “strictly enforced.”

Moreover, there are multiple bills working their way through the federal government that will hopefully provide some more answers and relief for the American people.  Although those options are only a few of the tools in the government’s toolbox, if used properly, they can help the nation combat COVID-19.

Zoinks! Can the FTC Unmask Advertisements Disguised by Social Media Influencers?

February 25, 2020
Administrative Law, Food and Drug, Social Media

Jennifer Satterfield, MJLST Staffer

Social media sites like Instagram and YouTube are filled with people known as “influencers.” Influencers are people with a following on social media that use their online fame to promote products and services of a brand. But, with all that power comes great responsibility, and influencers, as a whole, are not being responsible. One huge example of irresponsible influencer activity is the epic failure and fraudulent music festival known as Fyre Festival. Although Fyre Festival promised a luxury, VIP experience on a remote Bahamian island, it was a true nightmare where “attendees were stranded with half-built huts to sleep in and cold cheese sandwiches to eat.” The most prominent legal action was against Fyre’s founders and organizers, Billy McFarland and Ja Rule, including a six-year criminal sentence for wire fraud against McFarland. Nonetheless, a class action lawsuit also targeted the influencers. According to the lawsuit, the influencers did not comply with Federal Trade Commission (“FTC”) guidelines and disclose they were being paid to advertise the festival. Instead, “influencers gave the impression that the guest list was full of the Social Elite and other celebrities.” Yet, the blowback against influencers since the Fyre Festival fiasco appears to be minimal.

According to a Mediakix report, “[i]n one year, a top celebrity will post an average of 58 sponsored posts and only 3 may be FTC compliant.” The endorsement guidelines specify that if there is a “material connection” between the influencer and the seller of an advertised product, this connection must be fully disclosed. The FTC even created a nifty guide for influencers to ensure compliance. While disclosure is a small burden and there are several resources informing influencers of their duty to disclose, these guidelines are still largely ignored.

Evens so, the FTC has sent several warning letters to individual influencers over the years, which indicates it is monitoring top influencers’ posts. However, a mere letter is not doing much to stop the ongoing, flippant, and ignorant disregard toward the FTC guidelines. Besides the letters, the FTC rarely takes action against individual influencers. Instead, if the FTC goes after a bad actor, “it’s usually a brand that[] [has] failed to issue firm disclosure guidelines to paid influencers.” Consequently, even though it appears as if the FTC is cracking down on influencers, it is really only going after the companies. Without actual penalties, it is no wonder most influencers are either unaware of the FTC guidelines or continue to blatantly ignore them.

Considering this problem, there is a question of what the FTC can really do about it. One solution is for the FTC to dig in and actually enforce its guidelines against influencers like it did in 2017 with CSGO Lotto and two individual influencers, Trevor Martin and Thomas Cassell. CSGO Lotto was a website in which users could gamble virtual items called “skins” from the game Counter-Strike: Global Offensive. According to the FTC’s complaint, Martin and Thomas endorsed CSGO Lotto but failed to disclose they were both the owners and officers of the company. CSGO Lotto also paid other influencers to promote the website. The complaint notes that numerous YouTube videos by these influencers either failed to include a sponsorship disclosure in the videos or inconspicuously placed such disclosures “below the fold” in the description box. While the CSGO Lotto action was a huge scandal in the video game industry, it was not widely publicized to the general population. Moreover, Martin and Cassell got away with a mere slap on the wrist—“[t]he [FTC] order settling the charges requires Martin and Cassell to clearly and conspicuously disclose any material connections with an endorser or between an endorser and any promoted product or service.” Thus, it was not enough to compel other influencers into compliance. Instead, if the FTC started enforcement actions against big-name influencers, other influencers may also fear retribution and comply.

On the other hand, the FTC could continue its enforcement against the companies themselves, but this time with more teeth. Currently, the FTC is preparing to take further steps to ensure consumer protection in the world of social media influencers. Recently, FTC Commissioner Rohit Chopra acknowledged in a public statement that “it is not clear whether our actions are deterring misconduct in the marketplace, due to the limited sanctions we have pursued.” Although Chopra is not interested in pursuing small influencers, but rather the advertisers that pay them, it is possible that enforcement against the companies will cause influencers to comply as well.

Accordingly, Chopra’s next steps include: (1) “[d]eveloping requirements for technology platforms (e.g. Instagram, YouTube, and TikTok) that facilitate and either directly or indirectly profit from influencer marketing;” (2) “[c]odifying elements of the existing endorsement guides into formal rules so that violators can be liable for civil penalties under Section 5(m)(1)(A) and liable for damages under Section 19; 7;” and (3) “[s]pecifying the requirements that companies must adhere to in their contractual arrangements with influencers, including through sample terms that companies can include in contracts.” By pushing some of the enforcement duties onto social media platforms themselves, the FTC gains more monitoring and enforcement capabilities. Furthermore, codifying the guidelines into formal rules gives the FTC teeth to impose civil penalties and creates tangible consequences for those who previously ignored the guidelines. Finally, by actually requiring companies to adhere to these rules via their contract with influencers, influencers will be compelled to follow the guidelines as well. Therefore, under these next steps, paid advertising disclosures on social media can become commonplace. But only time will really tell if the FTC will achieve these steps.

Foodborne Illness Law: E. Coli, Salmonella, and More

February 3, 2020
Food and Drug, Product Liability, Public Health, Torts Law

Katherine Nixon, MJLST Staffer

Sometime in the fall of 2018, I walked into Chipotle hoping for a nice savory burrito bowl. The best burrito bowl—at least in my opinion—is made up of the following: brown rice, chicken, cheese, lettuce, hot salsa, sour cream, and guacamole. One ingredient missing can throw off the whole experience. Well, I walked into Chipotle only to find a printed sign on the glass in front of the various ingredients. Let’s be honest, that never means anything good. The sign notified customers that Chipotle would not currently be offering romaine lettuce due to an E. coli outbreak. At first, all I could think was “Noooo, not my beloved burrito bowl. What will it be like without the crunchy lettuce?”

In looking past my immediate concern over the negative effect that a lettuceless burrito bowl would have on my taste buds, I was ultimately thankful I had not eaten the romaine lettuce. Big picture things. It was discovered that the romaine lettuce came from a farm in Santa Barbara County, California. It was distributed through many avenues and not just to food establishments like Chipotle. Unfortunately, people became very sick. According to the Center for Disease Control and Prevention (CDC), 62 people were infected from 16 states and the District of Columbia. Further, 25 people were hospitalized and 2 people developed a form of kidney failure. This ended up being a big deal. That particular outbreak began in October 2018 and wasn’t declared over until January 9, 2019.

Believe it or not, E. coli outbreaks occur with some frequency. A massive outbreak that began in September 2019 was just declared over by the CDC on January 15, 2020. Again, the source of that outbreak was romaine lettuce. Other outbreaks in 2019 came from ground bison, flour, and ground beef. Aside from E. coli, there are other types of outbreaks as well. For instance, in 2019, there were several Salmonella outbreaks related to food items such as papayas and frozen raw tuna. Many people fell sick.

At this point, you might be wondering—what does this all have to do with law? It turns out there is a whole body of law generally referred to as “foodborne illness law.” I know—you definitely don’t learn about that in your normal law school curriculum. Yet, the name is somewhat self-explanatory. As succinctly put by the Public Health Law Center at Mitchell Hamline School of Law, “[A] person who is injured as a result of a foodborne illness may bring a civil cause of action against another by claiming that the other individual is legally liable for the harm caused by the foodborne illness.” Sometimes, there is even strict liability.

Overall, this type of law can be highly technical and usually involves the help of experts. It also can be quite difficult. Including the difficulty that often comes in discovering the source of a certain outbreak as well as the manufacturer of that source. It can be like piecing a giant puzzle together. However, once the pieces start to fit together, it all begins to make sense. If you have a science background, especially biology, this may be an area of law for you to consider. Next time you are at a family gathering and Uncle Eddy asks what you want to do, tell him you want to specialize in foodborne illness law. That will surely grab his attention.

 

 

Should the FDA Strengthen Pet Food Regulation?

October 25, 2019
Administrative Law, Animal, Food and Drug

Jennifer Satterfield, MJLST Staffer

Recently, the Food and Drug Administration (FDA) began an investigation following numerous reports of dilated cardiomyopathy (DCM), a type of heart disease, in dogs. The FDA is exploring a potential connection between DCM and certain diets containing legumes (e.g., peas or lentils), legume seeds (pulses), or potatoes as main ingredients. These ingredients are commonly associated with “BEG” diets (boutique companies, exotic ingredients, or grain-free diets). The FDA has compiled a spreadsheet of all the DCM reports prior to April 30, 2019. The most frequently identified brands include: “Acana (67), Zignature (64), Taste of the Wild (53), 4Health (32), Earthborn Holistic (32), Blue Buffalo (31), Nature’s Domain (29), Fromm (24), Merrick (16), California Natural (15), Natural Balance (15), Orijen (12), Nature’s Variety (11), NutriSource (10), Nutro (10), and Rachael Ray Nutrish (10).”

The DCM scare has led pet owners to question the safety of pet food products and turn to online forums for help, including a popular Facebook group called Taurine-Deficient (Nutritional) Dilated Cardiomyopathy. This group’s purpose is to “share information concerning Nutritionally-Mediated DCM among veterinarians, breeders, members of the Ph.D. & DVM research community, nutritionists, food brand representatives, nutrient suppliers, and concerned dog owners.” Some of the most common concerns among dog owners in this group are “what should I be feeding my dog?” and “what food is safe for the long term?”

Unfortunately, the FDA only requires that pet food be “[s]afe to eat; [p]roduced under sanitary conditions; [f]ree of harmful substances; and [t]ruthfully labeled.” However, the Federal Food, Drug, and Cosmetic Act (FFDCA), the statute that gives the FDA the authority to regulate pet food, does not require any pre-market review. Hence, pet foods do not need to be formally approved or undergo testing before hitting the shelves. Consequently, the federal government may have inadvertently allowed pet foods to reach the market that may not be safe for animals in the long term. For example, french fries are “safe to eat.” But, eating just french fries every day for a person’s entire life is not healthy, and will probably lead to medical complications. Since dogs generally eat the same dog food over the course of their entire lives, the food may be “safe to eat,” but may not be healthy as the dog’s sole source of nutrition.

Although the FDA has partnered with the Association of American Feed Control Officials (AAFCO), AAFCO does not have regulatory authority. For a dog or cat food to have a “complete and balanced” label, it must meet either one of the nutrient profiles established by AAFCO or pass a feeding trial using AAFCO standards. But AAFCO cannot enforce its standards, and, what is more, its recommendations may not even be good enough to ensure pet food safety in the long term. For example, both the nutrient profile and feeding trial methods leave uncertainty regarding nutrient bioavailability (the nutrients the animal’s body actually absorbs and uses).

Moreover, the AAFCO feeding trial protocol only requires eight animals to participate and only six out of the eight need to complete the entire trial over a period of twenty-six weeks. This extremely small number of test subjects over a relatively short period of time is not enough to make a determination on the safety or nutritional longevity of a specific pet food. As a comparison, a human-controlled feeding clinical trial used a “relatively small” sample size of twenty two people per group. Logically, pet food companies should be conducting feeding trials with a substantially larger number of test subjects over a much longer time period.

To prevent another scare, like the surprising potential link between DCM and certain dog foods, and to ensure the safety of pet food, the FDA should require stringent pre-market testing using sound scientific methods. But, since it is likely that the FDA does not have the statutory authority to increase its regulatory oversight of the pet food industry based on the FFDCA, Congress should step in and require it. It is also important to note that, while pet food is also regulated by states, these regulations typically deal with labeling and nutrient profiles. Considering the federal government’s failure to ensure pet food safety, states may also be able to step up and require pre-market testing. For many people pets are like family and, surely, pet owners want the safest, healthiest options for their beloved family members.

 

Will the Vaping Industry Go Up in Smoke?

October 2, 2019
Administrative Law, Food and Drug, Health

Stephen Wood, MJLST Staffer

It’s no secret that vaping has become increasingly popular. The number of users has increased from 7 million in 2011 to 41 million as of 2018. The total market is now worth an estimated $19.3 billion. Less clear is the future of industry regulation in light of the recent respiratory illnesses linked to vaping. On September 24, 2019, the Centers for Disease Control and Prevention reported that vaping was attributed to 805 illnesses and 12 deaths. Pressure is building on the industry’s major players. In the last week, we have seen the cancellation of a merger between two of the largest tobacco companies, Altria and Philip Morris, and the release of the CEO of Juul, Kevin Burns.

However, the respiratory illnesses associated with vaping haven’t been linked to a specific product, and it is unclear what the long-term effects of vaping are. Because of this uncertainty, some states have implemented blanket restrictions on the sale of vaping products, President Trump has proposed new regulations, and the CDC has issued warnings regarding their safety. This is blindsiding the industry, which has been free from regulation by the FDA until recently.

Vaping devices, also known as electronic nicotine delivery systems (ENDS), became subject to the FDA’s regulatory scheme for all tobacco products on August 8, 2016. The Deeming Rule placed ENDS in the same category of products as cigarettes and other traditional tobacco products, which have been regulated under the Family Smoking Prevention and Tobacco Control Act since 2009. For this reason, the minimum age for purchasing ENDS is 18 years old, and the marketing, manufacturing, and distribution of ENDS is heavily regulated.

Juul, in particular, has come under fire for its marketing strategies. Among other claims, many lawsuits allege that the company specifically targeted minors through its use of social media and distribution of enticing flavors. These practices have also been the focal point of the recent surge of state regulations, which “are filling what many see as a regulatory void caused by federal inaction.” For example, in Michigan, Governor Gretchen Whitmer implemented an emergency ban, limiting the sale of vaping products to those which are tobacco flavored. New York did the same but exempted menthol from the ban. Massachusetts, notably, implemented a four-month emergency ban on all products. President Trump’s proposed ban, on the other hand, would be limited to flavored products.

If President Trump’s proposal is adopted, the industry would see an estimated 80% loss in sales. It will be interesting to see what the regulatory landscape looks like once the smoke clears.

 

Treating Depression With Ketamine? How the Investment Was Made

March 15, 2019
Administrative Law, Biotechnology, Food and Drug, Health

Hunter Moss, MJLST Staffer

Depression is a serious mental disorder that afflicts millions of Americans each year. One in three of these individuals struggles to find a treatment method that alleviates their condition, and are aptly said to suffer from treatment-resistant depression. In the most severe cases, treating depression can be a life or death decision—depression is the leading cause of over 41,000 suicides every year. For those dealing with depression, every day is a struggle to persevere and try to regain a sense of normalcy.

A new therapy for treatment-resistant depression was approved by the Food and Drug Administration (FDA) earlier this week, one that could help those that have been unable to find relief elsewhere. The unexpected source of the therapy is esketamine. If the name of this drug sounds familiar, it is because the name is based on, and molecularly similar to, the street drug named ketamine. While originally synthesized in the 1960’s as an anesthetic and first used widely in the Vietnam War, ketamine is now known as a party drug, providing the user with mild hallucinations and a sense of euphoria. Due to its dangerous side-effects and potential for abuse, ketamine was placed on the Schedule III of the United States Controlled Substance Act in August of 1999.

In the early 1990’s, researchers at Yale University first recognized the potential for ketamine to treat the symptoms of depression. Since then, scientists sought to confirm the viability of ketamine as a treatment option for individuals who did not experience relief from other treatment methods. A 2012 study out of Baylor College of Medicine proved just that: 85% of patients with severe depression reported the treatment to be effective. Unlike selective serotonin reuptake inhibitors (SSRIs), which are most commonly prescribed to treat depression and can take weeks to build in a patient’s system before becoming effective, ketamine can provide nearly immediate relief with its full effect being felt in as little as two days.

With the science firmly in place, the next hurdle advocates of ketamine faced was of perception—in the eyes of the FDA and the public alike. Radical clinics began to emerge across the country to provide patients suffering from treatment-resistant depression with a safe, heavily-monitored environment to undergo care. Because ketamine had yet to be recognized as a potential aid for depression by the FDA, clinic physicians would often have to prescribe the drug under the guise of using it as an anesthetic. The “don’t ask, don’t tell” approach to a new treatment for a severe mental disorder created some inevitable quandaries for both doctors and patients, who would be unable to receive insurance coverage for a non-FDA approved treatment program.

While the medical community was well aware of the healing potential of ketamine, pharmaceutical companies were reluctant to make the investment. The average price-tag of a clinical trial for the FDA is $19m. There is certainly a market for the drug with countless Americans suffering from depression. The issue holding pharmaceutical companies back is related to patent law. In order to receive a patent, the proposed invention must be novel—and considering that ketamine has been around for nearly sixty years, that would be an impossible claim to make. Without patent protection, the multi-million dollar investment is bad economics for big pharma, even if the trials could provide relief for millions of Americans.

So why did Janssen Pharmaceuticals, the developer of a treatment method for depression based on ketamine, make the investment and receive FDA approval for its new drug Sprovato? The answer is because Sprovato is esketamine, a sufficiently different molecule from ketamine to be patentable. Certain molecules can be left-handed and have right-handed doppelgangers. While it is beyond the scope of this blog piece (and the ability of its author) to explain the difference between the two, esketamine is the left-handed version of ketamine’s right hand. The deviation between the molecules is a significant enough difference to pass the novelty requirement necessitated by the U.S. Patent and Trademark Office (USPTO). While there is some debate as to whether esketamine is as effective as its counterpart, esketamine passed the FDA’s clinical trials and, for the most part, has been received as a viable alternative to ketamine treatment. This development could help legitimize the countless ketamine clinics that have emerged across the United States over the last few years, yielding a promising new alternative for those struggling with severe depression. At the same time, the story of ketamine raises questions about the roles of several actors in the health care system, specifically pharmaceutical companies, the FDA and the USPTO, in delaying the introduction of life saving medication in order to adhere their respective financial and regulatory requirements.

Supervised Injection Facilities: A Step in the Right Direction to Mitigate the Opioid Crisis or a Violation of Federal Law?

February 19, 2019
Bioethics, Food and Drug, Pharmaceuticals

Jessica Swanson, MJLST Staffer

Plans for the nation’s first supervised injection facility hit a snag earlier this month when Philadelphia’s top prosecutor filed a federal complaint to keep it from opening its doors. Supervised injection facilities (SIFs) are legally sanctioned facilities that allow people to consume pre-obtained drugs under the supervision of trained staff and are designed to reduce the number of lives that would otherwise be lost to overdoses and provide a bridge to treatment. SIF staff members do not directly assist in consumption or handle any drugs brought in by clients, but are employed to provide sterile injection supplies, free testing, free distribution of the opioid overdose reversal medication, monitoring services for overdoses, and answers to questions about safe injection practices. SIF staff also offer general medical advice and referrals to drug treatment and other social support programs. There are approximately 120 SIFs currently operating in twelve countries around the world, but none in the U.S. However, a handful of U.S. cities, including New York, Seattle, Denver, San Francisco, and Delaware, have inched toward making SIFs a reality as each struggles to combat the increasing amount of drug-related deaths due to the opioid crisis. Philadelphia is by far the closest to becoming home to the nation’s first SIF, incorporated as “Safehouse.” However, on February 5th, the U.S. Attorney for the Eastern District of Pennsylvania, William McSwain, filed a lawsuit aimed at blocking Safehouse from opening its doors.

The civil lawsuit, which is jointly being pursued by Pennsylvania Attorney General Josh Shapiro and the Department of Justice in Washington asks a judge to declare such a facility illegal under federal law. Instead of waiting for Safehouse to open and then conducting arrests and a prosecution, McSwain is asking U.S. District Court Judge, Gerald McHugh, to rule on the legality of SIF plans in general. According to the complaint, a supervised injection site would violate a section of the 1986 Controlled Substances Act (CSA). The relevant section, also known as the “crack house statute,” was enacted during the height of the crack epidemic and was primarily used to shut down crack houses. The CSA makes it a felony punishable by up to 20 years in prison to knowingly open or maintain any place, regardless of compensation, for the purpose of using controlled substances. McSwain argues that Safehouse seeks to disregard the law and override Congress’ regulatory scheme by establishing, managing, and controlling sites in Philadelphia that will allow individuals to engage in the illicit use of controlled substances. Ronda Goldfein, vice president and attorney for Safehouse, argues CSA was not intended to apply to a medical facility focused on saving lives and moving people who are addicted to opioids into treatment. She argues the provision of the CSA in question is widely known to prosecute situations that involve crimes such as drug sales out of a car dealership or music festivals that allowed illegal drugs to flow freely. Safehouse, on the other hand, is a facility with good-faith efforts to improve public health.

Although other states like Pennsylvania are well-intentioned in opening SIFs, it is likely that the Controlled Substances Act is broad enough to encompass SIFs and thus bar them from operating. If Philadelphia or others want to open this type of site, they might want to steer their efforts towards changing the law. Overall, other cities that have expressed their intention of opening a SIF will be watching this case closely as it serves as an important test to determine the legality of SIFs.

Health Supplements: The “Wild West” of FDA Regulations

February 10, 2019
Administrative Law, Food and Drug

Gabe Branco, MJLST Staffer 

At some point, we all have taken a multivitamin and/or some type of dietary supplement. They are hard to miss in most stores such as Target or Wal-Mart.  The bright colored packaging and unfulfilling promises of “losing weight quickly” without dieting or “building muscle” without working out catches everybody’s attention. Most people assume that these products, ironically labeled “health” or “dietary” supplements, must be safe to ingest due to placing them in the same category as a “drug,” or because they deem the supplement to be “natural.” However, the reason people are mistaken is because the Food and Drug Administration (“FDA”) chooses to differentiate “health” products from “drugs.”

Under the FDA’s current regulatory scheme, “health” supplements are treated more like special foods than drugs. Drugs are considered unsafe until proven safe through clinical trials. These trials must be done on all drugs, even those that are sold without a required prescription. The trials must show that the drug is both safe and effective for the specified use. Once the drug is approved, manufacturers are subject to carefully monitored conditions and packaging requirements. The packaging requirement includes conditions the drug has been proven to treat, known side effects, contraindications, and unsafe interactions with other drugs. After the drug has been manufactured and released to the public for consumption, the FDA follows up on any adverse effects consumers and their doctors report, along with any adverse effects reported by the manufacturer.

“Dietary” supplements, on the other hand, are seen as safe until proven unsafe, a stark contrast to their drug counterpart. The Dietary Supplement Health and Education Act (DSHEA) defines “dietary” supplements as a category of food. As such, “dietary” supplements do not undergo the rigorous pre-manufacturing and post-manufacturing approval and monitoring process that drugs do. DSHEA prohibits supplements from containing anything that may have “a significant or unreasonable risk of illness or injury” when the supplement is used as directed on the label, or with regular use if there are no directions. While the regulation makes clear these supplements should not significantly or unreasonably expose the public to increased risk of harm, DSHEA fails to enforce the regulation with any preventative measures.

DSHEA effectively allows manufacturers to print any statement they wish on “dietary” supplement labels, so long as it is followed by the phrase “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This practice is troublesome because the statement may suggest or claim outright that the “dietary” supplement treats symptoms or results in an outlandish outcome if taken. Even with the FDA warning, consumers would have little to no reason to assume that supplements placed on shelves everywhere could contain none of the listed ingredients or unknown ingredients that can cause adverse health effects.

The FDA has the authority to stop any production of “dietary” supplement if it is shown there is an increased risk of harm to the public. However, this only occurs after the release of the supplement and subsequent adverse effects impact consumers. Due to the lack of pre-manufacturing testing requirements, many “dietary” supplements contain germs, pesticides, or toxic heavy metals that may adversely impact consumers. In addition, many “dietary” supplements either do not contain what is listed on the label, contain more or less of what is listed on the label, or even contain ingredients not listed on the label. This issue could also stem from parties other than the manufacturers and sellers. Without any regulations pre-manufacturing, many suppliers of ingredients may mix or substitute the ingredients sold to manufacturers with less expensive or tainted filler ingredients.

These issues become problematic when an ingredient the FDA would deem a “drug” finds its way into a “dietary supplement.” Many male enhancers or muscle building “dietary” supplements have been found to contain substances much like Viagra or Cialis, which are regulated as “drugs.” In addition, certain weight loss supplements have been found to contain sibutraimine, which has been banned in the United States. All of these supplements were recalled by the FDA in a reactionary manner. However, in most instances a “dietary” supplement may contain a drug that has little to no known effects. Having little to no known effects makes it more difficult to detect if a “dietary” supplement indeed contains a drug, and if it then must undergo the more rigorous FDA drug requirements. By providing manufacturers and sellers a pathway to produce categorical “drugs” and distribute them to the public without undergoing the rigorous FDA drug testing processes, DSHEA potentially does more deregulation than regulation.

FDA regulations concerning “dietary” supplements should be as stringent as regulations governing drugs. The simplest solution would be to implement the same pre-manufacturing and post-manufacturing procedures that are required of “drug” manufacturers into the “dietary” supplement realm. Doing so would fulfill DSHEA’s requirement that the “dietary” supplements do not cause a significant or unreasonable increase in risk of injury or illness. Additionally, this would allow the FDA to regulate “drugs” to its fullest potential.

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