On June 27, 2017, the U.S. Food and Drug Administration issued a press release stating how it would begin implementing its plan to increase competition for prescription drugs.  This comes on the heels of FDA Commissioner Scott Gottlieb's blog post last week, in which he indicated that the FDA would begin lifting the barriers to drug competition.  The first of the two new initiatives announced this week was to publish a list of branded drugs that were off patent but nevertheless had no approved generics.  The second initiative was to implement a policy to expedite the review of ANDAs for any drugs until there are three approved generics.  However, even though the press release indicated that these initiatives reflect the Administration's goal of improving access to prescription drugs, it did not address the potential reality that there may be little economic incentive for generic manufactures to seek marketing approval for these drugs.

The FDA press release was accompanied by two documents, each of which was directed to one of the two initiatives.  The first, entitled "List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic," includes two sections: (1) a list of drug products for which the FDA could immediately accept an ANDA; and (2) a list of drug products for which there might be legal, regulatory, or scientific issues.  The FDA suggested that any sponsor wishing to seek approval of a drug product on the second list should first submit an initial inquiry to the Office of Generic Drugs.  Such drug products on this second list can include those that are more appropriate for the 505(b)(2) abbreviated approval pathway, those for which there are "regulatory complexities," and those that are proteins and may be transition products pursuant to the BPCIA.  No NDA drug products that have been approved in the past year have been included, and the FDA suggests that it will update the list every six months.

The second document was an updated "Prioritization of the Review of Original ANDAs, Amendments, and Supplements," as found in the Manual of Policies and Procedures for the Office of Generic Drugs.  The accompanying "Change Control Table" indicates that the revisions found in this version were to "include prioritization of generic products for which there are fewer than three ANDAs approved for the reference listed drug (RLD) and updated certain external references."  Nevertheless, this prioritization appears to be contingent on there being no blocking patents.  For submissions that contain Paragraph IV certifications, additional criteria were provided before expedited review could be received.

These documents related to the expediting of certain ANDAs were released about a week after newly appointed and confirmed Commissioner Gottlieb posted to his blog, the FDA Voice.  In this blog post, Commissioner Gottlieb indicated that the FDA was working on a Drug Competition Action Plan to address "some of the scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs."  The post, however, explicitly excluded patent and statutory exclusivity periods from these obstacles.  The only example of "gaming" the system provided was the alleged "increasing unavailability of certain branded products for comparative testing," either through restrictions placed on distributors, or the adoption of voluntary Risk Evaluation and Mitigation Strategies (or REMS) by the NDA holder.  The Commissioner also indicated that the FDA would be looking at how best to coordinate with the FTC to identify and publicize anti-competitive practices.  Finally, he announced a July 18 meeting, in which the FDA would seek input from the public about ways in which the current rules were no having their intended effects.  Of course, this post reverses a long-standing principal of the FDA to not get involved in issues of drug pricing.  We will continue to monitor any updates from the FDA or the current administration on any policies related to generic drugs.