The United States Food and Drug Administration (FDA) has recently publicized a list of forty-one branded drug companies that have allegedly blocked access to drug samples in an attempt to obstruct the development of generic drugs.
The list includes complaints about branded drug makers improperly using Risk Evaluation and Mitigation Strategy (REMS) requirements to restrict access to samples of branded drugs that are necessary to conduct FDA-required tests to demonstrate bioequivalence. In other instances, FDA claims branded drug companies may have placed restrictions in commercial agreements that limit the ability of distributors, wholesalers or specialty pharmacies to sell samples.
This announcement comes less than a week after the Trump Administration released a broad drug pricing blueprint, American Patients First, and seems to be part of an ongoing effort from FDA Commissioner Scott Gottlieb to spotlight anticompetitive behavior in the prescription drug market.
In a statement made May 17, 2018, Commissioner Gottlieb noted that the FDA has received over 150 inquiries from generic drug developers seeking assistance in obtaining samples from brand companies. In response, he said the FDA will determine whether these products have in place a REMS program that may impact distribution – a reason frequently cited by the brand companies as the reason behind refusing to provide samples. Commissioner Gottlieb also mentioned that the FDA is notifying the Federal Trade Commission (FTC) about the inquiries and encouraged generic companies to raise their own cases with that Agency, which largely policies anticompetitive behavior.
However, as Commissioner Gottlieb noted, even in cases where the FDA confirms there is an existing REMS program with Elements to Assure Safe Use for the brand drug that impacts distribution, generic drug developers should be able to secure samples of the product. To facilitate the transfer of samples in these cases, the FDA has a voluntary process through which generic companies can submit their bioequivalence testing protocols to the agency, and evaluate these protocols to ensure that their plan for testing the product contains safety protections comparable to the brand product’s REMS program. Assuming that the generic drug developers’ plans include appropriate protections, then the generic drug developers can request that the FDA send a letter to the brand company stating that the REMS program does not mean the brand drug maker can’t sell their product to generic drug developers for comparative testing.
Samples of the reference listed drug (RLD) – also known as the brand drug – are important to prospective generic applicants because in order to obtain approval for the generic drug, the generic company must show (in addition to other things) that its version of the product is bioequivalent to the RLD. This usually requires the generic company to conduct bioequivalence studies comparing its product to the RLD, and to retain samples of the RLD used in testing after a study is complete. To conduct these kinds of bioequivalence studies, the generic company needs to obtain samples (generally between 1,500 and 5,000 units) of the RLD.
The list publicized by the FDA reflects the RLD access inquiries FDA has received from prospective generic applicants about marketed RLD products. FDA has also received RLD (or reference product) access inquiries from prospective applicants who intend to submit new drug applications under section 505(b)(2) of the FD&C Act or biologics license applications under section 351(k) of the Public Health Service Act. This webpage, however, is focused on providing transparency about the potential impact of this issue on generic drug market competition.
Generic drug makers have been pressing Congress to pass legislation, the “Creating and Restoring Equal Access To Equivalent Samples Act of 2017,” or the “CREATES Act of 2017” (S. 974), that would allow them to sue over these “gaming tactics.” Though it has bipartisan support in both chambers of Congress, it has largely stalled in the face of opposition from branded drug manufacturers.
FDA plans to update the list semi-annually.