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

By Nicholas J. Diamond

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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The Notable Absence of Regulating Cannabis in FDA Commissioner Scott Gottlieb’s Keynote Address to FDLI 2018

by Tara Sklar

At the Food and Drug Law Institute (FDLI) 2018 Annual Conference, the Commissioner of Food and Drugs, Scott Gottlieb, gave the Keynote Address to kick-off the largest turnout yet for this event of over 900 attendees. Commissioner Gottlieb’s remarks started off with how previous FDA Commissioners used this opportunity to recap the past year, but he would be different, he would lay out the strategic priorities for next year.

The room went nearly silent, as Commissioner Gottlieb steadily went through the many sectors the agency oversees, and where he believes the FDA will play a larger leadership role, including in the epidemics of addition (opioid crisis), drug costs, and greater access to generic competition. He laid out a vision that most people in the room would probably subscribe to, including “You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.”[1] Close to the end of his thirty-minute speech, Commissioner Gottlieb firmly addressed the companies that produce e-cigarettes, and said, “If you target kids, then we’re going to target you.”[2]

Indeed, Commissioner Gottlieb mentioned so many FDA strategic priorities, and in such unequivocal detail for how they plan to regulate, that when the President & CEO of the FDLI, Amy Comstock Rick, thanked him and introduced the follow-up panel to discuss the issues Commissioner Gottlieb raised, she said, “We reserved one-hour in the conference to discuss Commissioner Gottlieb’s Keynote Address, but we may need five.” However, there was an area that was not brought up in Commissioner Gottlieb’s wide-ranging speech, despite its very active place in the media and scientific journals calling for the FDA to have a greater role, and more consistent guidance, and this prominent area is the future regulation of cannabis. Read More

Was March a Turning Point for Tobacco Regulation in the U.S.?

By Nicholas J. Diamond

March was an important month for tobacco control in the U.S. While historically less progressive than other countries in regulating tobacco products, three recent developments offer encouraging signs of change. They also remind us of the critical role that the U.S. Food & Drug Administration (FDA) plays in public health policymaking.

The Three ANPRMs
Last month, the FDA released three advanced notices of proposed rulemaking (ANPRM) on tobacco-related products. An ANPRM is a formal invitation for stakeholders to submit comments before a federal agency issues a proposed rule. In practical terms, an ANPRM enables stakeholders to weigh in on, and even potentially shape, a forthcoming policy by responding to specific issues for input.

Released on March 16, the first ANPRM addresses the development of a tobacco product standard for a maximum nicotine level in cigarettes. The FDA seeks comment on a number of policy design considerations including, among others: the merits of various maximum nicotine levels (e.g., 0.5mg nicotine/g); to which products a maximum nicotine level should apply (e.g., combusted cigarettes, cigars, pipe tobacco); and whether to use a stepped-down, or gradual, reduction in maximum nicotine levels.

Importantly, the FDA highlights factors that could reduce the benefits of a future policy and seeks comment on how to addresses them. For example, current smokers could switch to a tobacco product not covered under the policy or use that non-covered product in addition to the currently used (covered) product. Similarly, current smokers could increase the number of cigarettes smoked to maintain an equivalent level of nicotine overall. Read More