Photograph of a person holding an e-cigarette in one hand and traditional cigarettes in the other hand.

FDA’s Warning Letter to Juul & the First Amendment

By Daniel Aaron

On September 10, 2019, the Food and Drug Administration (FDA) issued a warning letter to Juul asserting that the vaping manufacturer had violated federal law by illegally marketing its e-cigarettes as safer than other products. Citing evidence uncovered at a July 2019 House Subcommittee hearing as well as industry documents, FDA claims that Juul marketed its products as modified-risk tobacco products (MRTPs) without an FDA order allowing the product to be marketed as such. Therefore, FDA concluded, Juul’s products are adulterated.

At first blush, this seems like a heavy-hitting letter. FDA warning letters are an effective enforcement tool because they intimidate regulated entities and carry the threat of further enforcement. FDA likely hopes Juul will bring itself into compliance with federal law by ceasing to market its products as lower-risk.

However, enforcement letters carry no legal weight in and of themselves. Should Juul continue to market its products as lower-risk, there may be a long legal battle implicating the First Amendment.

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Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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The FDA’s NEST Initiative and Women’s Health

The history of medical device regulation in the United States has been shaped by the prominent failure of individual devices, many of which were indicated for women.

The Dalkon Shield intrauterine device infamously ushered in the 1976 amendments to the Federal Food, Drug, and Cosmetics Act, establishing the first pre-market notification and approval process for medical devices in the United States. Similarly, a series of failures among devices designed for women’s health—including the power morcellator, the Essure System, and pelvic mesh—has recently invigorated the FDA’s focus on its post-market regime. Read More

The Funding Effect: How Drug Manufacturers Design Clinical Trials to Produce Favorable Results

By Ryan J. Duplechin

Many consumers are unaware that the U.S. Food and Drug Administration (“FDA”) does not test drugs in the approval process. Instead, drug manufacturers test their drugs and submit their own results to the FDA for review. Hoping to convince the FDA and investors of the safety and effectiveness of their new drug, manufacturers go to great lengths to report positive results in clinical trials. Read More

Illustration of mitochondrial donation

Time to Revisit the Prohibition on So-Called “Three-Parent IVF”?

In an editorial appropriately titled, “This Editorial Is Not About Designer Babies,” the New York Times supported efforts by the Petrie-Flom Center and suggested it was time for Congress to consider lifting the effective ban on mitochondrial replacement therapies — sometimes colloquially but inaccurately referred to as “three-parent IVF.”

The piece referred to the Petrie-Flom Center’s upcoming public event and Roundtable, where experts will have a general conversation about the state of the law in the U.S. and elsewhere and to, as a group, discuss whether the prohibition against MRT might be lifted and, if so, how that might be accomplished.

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New HarvardX Course on the FDA and Prescription Drugs

Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics!

Check out a free HarvardX online course, “The FDA and Prescription Drugs: Current Controversies in Context,” put together by Petrie-Flom Center affiliates Dr. Aaron Kesselheim, Dr. Ameet Sarpatwari, Dr. Jonathan Darrow, and many others, that is now open for enrollment. (Disclosure: I did not play any role in the development or making of the course, but I am serving as a teaching assistant/discussion moderator for the course). Read More

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Aaron Kesselheim and Jonathan Darrow on “The Week in Health Law” Podcast

I am joined by Aaron Kesselheim and Jonathan Darrow, faculty members at Harvard Medical School and members of the Program On Regulation, Therapeutics, And Law (PORTAL) group directed by Dr. Kesselheim.

The conversation began with a discussion about drug price narratives, including whether drug prices are still increasing? We also critically discussed at least some of Vox’s 8 ideas for bringing down drug prices, and some better ones! The conversation then shifted to some issues, including pricing and expectations, with gene therapy drugs. We spent a short time on the resignation of Food and Drug Administration Commissioner Scott Gottlieb before ending our discussion with some information about PORTAL’s innovative online course, “The FDA and Prescription Drugs: Current Controversies in Context.”

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FDA scott gottlieb

FDA Commissioner Gottlieb Resigns: Twitter Reactions

Citing wanting to spend more time with his family, Food and Drug Administration commissioner Scott Gottlieb announced his resignation this week. Broadly liked on both sides of the aisle and within the biopharma industry, Gottlieb, a former physician and cancer survivor, made teen tobacco use a major issue during his two-year tenure.

In addition to working on lowering drug prices and bringing generic drugs to the market faster, both priorities for the Trump administration, Gottlieb has been a fierce advocate for a number of other public health issues, focusing the FDA’s attention on combating the opioid epidemic, creating harsher regulations for dietary supplements, and even “preserving Michelle Obama’s sugars labeling.”

Gottlieb had previously worked as a venture capitalist and board member for pharmaceutical companies, and made millions from his work in that industry, which caused alarm on the left when his appointment was originally announced. However, the commissioner surprised critics by divesting his interest in drug companies and calling for stronger and updated regulations across health-related industries.

Given his penchant for being chatty on Twitter, we rounded up some of the reactions to Gottlieb’s resignation from Bill of Health’s friends and family.

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hand reaching for blue pills

Should Non-opioid Analgesics have “Opioid Sparing” as a Label Claim?

Most meetings of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) are held to review a New Drug Application (NDA), usually for a novel opioid preparation. But, on November 15, the AADPAC discussed the concept and implications of “opioid sparing” as a potential product label claim for a non-opioid type of medication.

Although trends in outpatient opioid prescriptions appear to be heading in an encouraging direction (see figure below), the demonstration that a non-opioid medication could further decrease the overall use of opioids for acute pain has obvious implications for the amount of opioids prescribed and taken by patients who undergo painful surgical procedures. This will also decrease exposure in the community where prescribed opioids may become diverted for recreational use.

In recent years, some across-the-board measures (e.g. state laws that limit the duration of prescribed opioids) have attempted to reduce opioid prescribing, but as the FDA emphasized in their presentation at the meeting, these “one size fits all” strategies will not account for individual patient variation, and may lead to inadequate pain treatment in some patients. Read More

FDA scott gottlieb

How Scott Gottlieb is Wrong on the Gene Edited Baby Debacle

I am a huge fan of FDA Commissioner Scott Gottlieb.

He is by far my favorite Trump appointee — though the competition isn’t tough, to be honest— and he is doing great things at FDA on issues such as mobile health, software, and so on.

But in his comments on the news that gene edited embryos in China had led to live births, I think he has it wrong.

“The response from the scientific community has been far too slow and far too tepid, and the credibility of the community to self-police has already been damaged,” he said to Biocentury. “Governments will now have to react, and that reaction may have to take consideration of the fact that the scientific community failed to convincingly assert, in this case, that certain conduct must simply be judged as over the line.” Read More