FDA’s Version of the Scarlet Letter?

May 23, 2018By Sara W. Koblitz

FDA announced last week its newest initiative to address alleged “gaming” tactics that FDA believes are used to circumvent the delicate balance of innovation and competition set forth by Congress in the Hatch-Waxman Act.  As part of FDA’s Drug Competition Action Plan, FDA has published a list identifying all drug products for which FDA has received an “RLD access inquiry” related to the limited distribution of the marketed RLD. This list includes the RLD sponsor, the drug product, the number of inquiries received, and any communication from FDA to the sponsor.

In this endeavor, FDA makes public certain information about RLDs for which would-be generic applicants have not been able to obtain samples necessary for generic drug development.  FDA cites failure of the RLD applicant to voluntarily provide such samples as an impediment to patient access to affordable generic alternatives.

In the announcement, FDA explains that it has received inquiries from prospective generic applicants about the limited availability of samples of certain RLDs for generic testing.  Only half of the RLDs listed by FDA are subject of a restricted distribution REMS, the imposition of which makes interstate shipment of the drug much more difficult.  FDA has published guidance indicating that providing the RLD to an interested generic firm would not violate a REMS, and a generic applicant can request a Safety Determination Letter from FDA directly to the sponsor stating this. Products for which a restricted-distribution REMS has not been imposed are not eligible for a Safety Determination Letter; instead, FDA refers the issue to the FTC.

FDA decided to publish this list of RLD access inquiries to provide transparency to the general public about this potential impediment to generic drug market competition. The list includes about 50 different drug products all with at least one RLD access inquiry.  Of note, a number the RLD applicants are themselves generic drug companies.  While Commissioner Gottlieb has denied that this list is an attempt to shame drug companies into providing access, it does appear that, in the absence of any statutory authority, the agency is using “transparency,” publicity, and public reaction to pressure these sponsors to change their practices.

It remains to be seen how effective such a publicity effort will be at addressing this issue. RLD applicants have little incentive to actively aid entities wishing to develop generics of their products regardless of the increased attention to the issue.

All of this said, FDA has no authority to force sponsors to cooperate with their competitors and provide access to their products – and FDA knows that. This exercise shows an FDA willingness to use its bully pulpit to speed up the availability of generic competition.  Only time will tell if this is an effective strategy, but FDA is undoubtedly attempting to be responsive to Congressional pressure regarding pricing concerns and the alleged “gaming” the system discussed in detail at last summer’s public meeting.