Weekly Roundup 2.9.18

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…