As Gottlieb’s Team is Assembled, His Visions Unfold

As reported by FDA WebView (here [subscription required]), FDA announced the appointment of three former congressional staffers Dr. Gottlieb has chosen to add to his current team, as his team builds his vision for the Agency is becoming more clear.  And it is not the usual vision we have seen from past commissioners.

As an example, it appears that cost considerations may be a more important factor in FDA policy and decision making.  For instance, Gottlieb recognizes that having multiple generic products approved make good economic sense for consumers, as typically, the more generics applications for a product that are approved, the lower their cost.  There are a number of pieces of legislation that look to speed up the approval of generic drugs, prioritize those generic drugs with no or little competition, and also award certain period of exclusivity for firms that get a first generic approved, where there is no competition and there is no patent or exclusivity associated with the reference listed drug.  In addition, Congress and FDA are looking at ways to minimize the REMS and restricted distribution program’s impact on generic competition.

Will all of this take legislation, or does the FDA have the authority to make certain changes to improve generic competition via policy changes alone?  I believe the answer is, it depends!  Obviously, certain awarded periods of market protection most likely will take legislative change, but other initiatives, like prioritizing certain ANDA reviews and approvals, may, I believe, be made simply by policy changes. And Dr. Gottlieb appears ready to make those changes.

Recognizing that FDA is not supposed to take pricing into consideration in making approval decisions, one would think that competition decisions are a clear directive dating back to the passage of the landmark Drug Price Competition and Patent Term Restoration Act of 1984.  It looks like Gottlieb has already figured that out and we expect changes to be coming relative to application priority with or without legislation. However, there are two things that might derail the ship.

First, there could be significant backlash from innovator companies and/or other generic firms that see that their applications are being delayed in favor of the others that skip to the front of the line.  Secondly, is the generic drug review process itself.  When prioritizing application review, the ultimate goal is for application approval; an ANDA with a complete response letter does nothing to increase competition.  Thus, the ability of the Office of Generic Drugs and Office of Product Quality to improve their first-cycle approval rate will be critical to success of this program.  In addition, the ability of those two offices to be able to whittle down their current workload and begin approving more ANDAs than they currently receive each month will also make a significant different in the success of a priority review program, because if they get their first-cycle approval rate up to 40% (most recently reported at 8%), there may be no need for a priority review program.