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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 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

Commentary: Do We Really Need a New, More Powerful Opioid?

The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx.

Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In the midst of the current opioid crisis, why would anyone think that the availability of another powerful opioid is a good idea?

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hand reaching for blue pills

The Rotten U.S. Antiparasitic Drug Market

Recently, there has been a lot of media attention on galling price hikes of generic drugs.

Historically, the social contract in pharmaceutical pricing has been tolerating expensive brand-name drugs while they have been on patent (a government-granted monopoly), followed by allowing low cost generics to rush to market after patent expiration. Yet these norms are now being challenged in the setting of increased generic manufacturer consolidation and single-source generic drugs.

Probably the most well known example is the case of Martin Shkreli (the so-called “Pharma Bro”) and Turing Pharmaceuticals, which bought out the rights of pyrimethamine (Daraprim), a key treatment for Toxoplasmosis and other infectious diseases, raising the price from $13.50 per pill to $750 per pill.

Note that even the pre-price hike price is significantly more than people other countries pay. In the UK it costs only $0.66 per pill and in Australia it is $0.18 per pill.

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two glasses of milk

The Cry Over Fake Milk

A debate has been brewing between the cattle milk industry and the plant-based milk industry (producing drinks made from ingredients such as almonds, soy, and rice), regarding what products can actually be labeled “milk.”

This has motivated the Federal Drug Administration to review how milk is defined under federal regulations, in order to protect public health and ensure that consumers are purchasing what they expect based on a product’s label.

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Count Your Calories, Says the FDA

 

Fast Food emblems set on chalkboard. Hand drawn doodle style. Image via Thinkstock.

On May 7, a provision of the Affordable Care Act (ACA) relating to nutrition-labeling requirements finally went into effect, following three extensions to its compliance date by the U.S. Food and Drug Administration (FDA). In brief, under the requirements, most chain restaurants must now display calorie counts per serving on their menus. You may have already noticed that some of your favorite establishments have been ahead of the curve for awhile.

As I outline below, I broadly agree with the direction of the nutrition-labeling requirements, but highlight weaknesses and offer a way forward.

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