February. When the inconvenient bursts of weird precipitation, the cold and the dark starts really getting on your nerves. They made it the shortest month for a reason. Facing the prospect of yet another government shutdown, it appeared that at least some members of Congress have come to their senses – and then we had a brief nocturnal shutdown during the night last night. Did anyone notice? And, even though we have short days – and definitely long nights, here is a little bit of what happened regarding our world and FDA.
- Generic Approvals Set Record in 2017 – While FDA does not have authority over the pricing of drugs, the approval of new generic versions of brand name drugs does facilitate the drop in price for the category – and the more within a particular category, the more likely the drop is to be significant. Drug pricing was a major concern raised during the confirmation hearings for Commissioner Gottlieb. That is perhaps one of many reasons then to note that according to a blog posting on FDA Voice, 2017 saw 1,027 new approvals, an increase of 214 over the banner year of 2016. As the blog posting points out, generic drugs comprise 89% of all prescriptions filled in the U.S. and of the approvals, there were 80 that were “firsts” meaning that in those categories, prices would likely come down in the face of generic competition. And if you really want to go in the weeds, you can look at the Office of Generic Drugs Annual Report. On a related note, there were also five biosimilars approved during 2017, one more than had been approved during the previous two years combined.
- FDA Renews Focus on Kratom – FDA Commissioner Gottlieb released a statement this week outlining additional concerns related to the use of Kratom. It is the second public facing statement FDA has made about Kratom within the last several months and the second time in a week that FDA has focused on a substance that was involved in opioid misuse. (Last week the Commissioner discussed revised packaging to curb potential misuse of OTC loperamide.) In this extensive communication on Kratom, Commissioner Gottlieb laid out the specifics regarding adverse events associated with this botanical substance, and discussed scientific analysis that demonstrated evidence of underlying opioid properties. The action not only demonstrates that FDA is concentrating on addressing the opioid situation and is addressing it through process, not a single set of events, even willing to nibble at what might be the outer edges of abuse and misuse at times. Neither the loperamide communication nor this stated the scope of the issue being addressed by the action.
- Senators Weigh in on FDA Approval Deliberation – While not able to find link to the original letter, it was widely reported in media this week that 10 U.S. Senators sent a letter to FDA to weigh in on deliberations in the wake of an advisory committee meeting, also reported here in The Weekly Roundup just two weeks ago. It was a meeting of the Tobacco Products Scientific Advisory Committee regarding claims associated with the heated tobacco product iQOS. The letter from the Senators, all Democrats, urged FDA to reject the application. It is noteworthy, not just for the fact that it involved 10 Senators, nor that it was about the heated tobacco product, but because in my observation, high profile weigh-in by elected officials in FDA deliberations on product approvals is rare. I have seen members of Congress send letters or statements during open public comment periods of advisory committees, and even seen a Senator and a member of the House show up to provide comment during that session, but those have usually been meetings involving a policy issue, not a product approval. It is worth noting, particularly for those products which have societal issues associated with them coming before advisory committees.
Upcoming Events to Keep an Eye on This Week
- Senate HELP Committee – Full Committee Hearing – Improving Animal Health: Reauthorization of Animal Drug User Fees – February 13, 2018 – Note FDA will be testifying.
- Anesthetic and Analgesic Drugs Advisory Committee – On February 14-15, the committee will hold meetings on two topics. On the 14th, it will devote a half day to consider approval of an opioid analgesic in conjunction with the Risk Management Advisory Committee. Thereafter the committee will meet on its own to consider an NDA for a product delivering local analgesia.
Regulatory Developments in Pharma/Biotech/Devices