United States Capitol Building - Washington, DC.

Psychedelic Policy on the Federal Level: Key Takeaways from a Petrie-Flom Center Panel

By James R. Jolin

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates.

The conversation was situated against the backdrop of the “psychedelics renaissance” in the United States, which has been fueled by a wave of local and state legislation reducing or eliminating the criminal penalties associated with these substances.

Though many localities have made significant strides in addressing the legal questions surrounding psychedelic substances such as psilocybin and dimethyltryptamine (DMT), federal policymakers have not pursued similar initiatives.

Suggestions and considerations for federal psychedelic policy thus formed the substance of the discussion among the panelists:

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Group of athletic adult men and women performing sit up exercises to strengthen their core abdominal muscles at fitness training.

Exercise Equipment Advertisements and Consumer Distrust

By Jack Becker

Are you ready to learn about “the most innovative piece of exercise equipment ever”? To take advantage of “the momentum of gravity to target your entire midsection”? Doesn’t everybody want to “lose those love handles nobody loves”? To finally “have the flat washboard abs and the sexy v-shape [they’ve] always wanted”? Within “just weeks, not months,” anybody can “firm and flatten their stomach.” And “best of all, it’s fun and easy and takes just three minutes a day.”

Despite its endorsement from an expert fitness celebrity and customer testimonials, you might be skeptical of the Ab Circle Pro’s claims. After all, can you really cut out five minutes from the iconic 8-Minute Abs routine?

Massive and misleading promises are an unfortunate reality for many exercise equipment advertisements. Illegitimate advertising claims can harm consumers and impact overall consumer trust, which creates an uphill battle for honest companies. The Federal Trade Commission (FTC) already regulates exercise equipment, but supplementing its efforts with more consumer education and industry self-regulation could be a winning combination to restore trust in the fitness industry.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Pig Hearts for Humans and the FDA

By Jacob Balamut

David Bennett, a man who recently underwent the world’s first successful xenotransplantation organ surgery, died last month after a sudden and as yet unexplained period of rapid deterioration.

Bennett, who was 57 years old, had been suffering from end-stage heart disease. With limited options for treatment, he underwent an experimental emergency procedure to replace his damaged heart with a genetically modified pig’s heart. The pig was genetically modified to limit the likelihood that Bennett’s immune system would reject the heart.

Many researchers and clinicians alike see the potential for genetically modified animal organs to serve as a solution to our organ transplant and supply issues. The Health Resources and Services Administration estimates that 17 people die per day on the candidate waiting list. These deaths are the result of a lack of supply of organs, which has been a longstanding issue within the United States.

However, currently, the U.S. Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use”). The lack of approved xenotransplantation products stems from a lack of safety data and concerns regarding the potential for cross-species infections to occur.

In 2016, the FDA updated previously existing guidance for xenotransplantation. The purpose of the guidance was to inform the industry of how the FDA would be handling xenotransplantation applications and to provide recommendations.  In order for xenotransplantation products to be approved, the following process must occur.

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Cigarettes.

Tobacco Issues Awaiting Robert Califf at the FDA

By Cathy Zhang

Yesterday, the Senate confirmed Dr. Robert Califf for his second, non-consecutive term as Commissioner of the U.S. Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions.

Prior to his first term as Commissioner during the Obama administration, Califf, a cardiologist, served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.

In addition to fielding scrutiny over mifepristone access, reviewing opioid regulations, and handling COVID-19 vaccine and treatment approvals in the midst of a pandemic, Califf will be overseeing the FDA at a time when public health advocates are anticipating agency action on several tobacco issues.

Two major developments expected in this area include a menthol ban and greater regulation of e-cigarettes.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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Vial and syringe.

Causes of COVID Vaccine Hesitancy

By Jasper L. Tran

Vaccinated individuals — like Tolstoy’s happy families — are all alike; each unvaccinated individual is hesitant for her own reason.

Prior research conducted in developed countries reveals five main individual-level determinants of pre-COVID vaccine hesitancy (commonly referred to as the 5 C model drivers of vaccine hesitancy): (1) Confidence (trust in vaccine’s effectiveness and safety, vaccine administrators and their motives); (2) Complacency (perceiving infection risks as low and vaccination as unnecessary); (3) Convenience / Constraints (structural or psychological barriers to converting vaccination intentions into vaccine uptake); (4) Risk Calculation (perceiving higher risks related to vaccination than the infection itself); and (5) Collective Responsibility (willingness to vaccinate to protect others through herd immunity).

COVID-19 vaccines see these five hesitancy determinants again, only further exacerbated by waves of misinformation promulgated on social media, including through “bot” accounts, that prey on the concerns and insecurities of an already vulnerable public.

On the one hand, irrational and unreasonable conspiracy theories about COVID-19 and its vaccine abound among the anti-vaxxers — a subgroup of science deniers. These conspiracy theories include:

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Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

By Govind PersadPatricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Should We Regulate Direct-to-Consumer Health Apps?

By Sara Gerke and Chloe Reichel

According to one estimate, over 318,000 health apps are available in app stores, and over 200 health apps are added each day. Of these, only a fraction are regulated by the U.S. Food and Drug Administration (FDA); those classified as “medical devices,” which typically pose a moderate to high risk to user safety.

In this final installment of our In Focus Series on Direct-to-Consumer Health Apps, we asked our respondents to reflect on this largely unregulated space in health tech.

Specifically, we asked: How can/should regulators deal with the assessment of health apps? For apps not currently regulated by the FDA, should they undergo any kind of review, such as whether they are helpful for consumers?

Read their answers below, and explore the following links for their responses to other questions in the series.

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Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

How Social Movements Have Facilitated Access to Abortion During the Pandemic

By Rachel Rebouché

Before the end of 2021, the U.S. Food and Drug Administration (FDA) will reconsider its restrictions on medication abortion. The FDA’s decision could make a critical difference to the availability of medication abortion, especially if the Supreme Court abandons or continues to erode constitutional abortion rights.

Under that scenario of hostile judicial precedents, a broad movement for abortion access — including providers, researchers, advocates, and lawyers — will be immensely important to securing the availability of remote, early abortion care.

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