A Battle Over REMS & Samples For Generics

As the US Senate and House get ready to reconcile their differing versions of the Food and Drug Administration Safety and Innovation Act, which most people refer to as PDUFA, brand-name drugmakers and their generic rivals are squaring off over language that was recently inserted into the Senate bill concerning Risk Evaluation and Mitigation Strategies, or REMS programs.

Specifically, the behind-the-scenes squabble centers on a provision in the Senate version that calls for brand-name drugmakers to provide samples of their medicines, including biologics. Generic drugmakers and their allies, including some insurers and pharmacy benefit managers, complain that brand-name drugmakers have been using the strict distribution provisions of the REMS regulation as an excuse not to provide samples for development and testing.

"Unfortunately, these REMS programs are being used to block access to comparator products to halt generic drug and biosimilar product development and are thereby blocking fair and timely generic drug and biosimilar competition. Generic and biosimilar applicants’ access to product samples for testing purposes is critical to ensuring continued access to affordable medicines," the Generic Pharmaceutical Association wrote to House and Senate negotiators earlier this week.

"However, branded drug companies are increasingly using REMS programs established by the FDA to restrict distribution exclusively to certain entities within the supply chain and to patients, precluding distribution to generic drug and biosimilar manufacturers. In addition, many companies are using self-imposed restricted distribution programs, without a formal mandate from FDA, as a tool to restrict distribution, which also results in generic and biosimilar companies’ inability to acquire samples for development and testing" (here is the letter).

In response to their complaints, an amendment known as Section 1131 was recently added to the Senate bill (here is the bill and here is the amendment), but the House version lacks this language (here is the bill).

Instead, the House version includes a change to how the FDA must respond to Citizen's Petitions that refer to an application for a generic or biosimilar. The agency would be required to respond in 150 days, not 180 days, suggesting a copycat med might be approved 30 days earlier than otherwise, but generic drugmakers argue this is largely theoretical, since there is no way to know how many petitions would be filed and, therefore, how many medicines might be affected.

And so, the scene is set for some old-fashioned horse trading. Meanwhile, the Congressional Budget Office recently estimated that implementing Section 1131 of the Senate bill, along with other provisions, "would reduce barriers to market entry for lower-priced drugs arising from certain labeling exclusivities, would reduce direct spending for mandatory health programs by $753 million" between 2013 and 2022 (read here).

Sources tell us that PhRMA is actively lobbying to convince the House and Senate negotiators not to include the REMS language in the final version of the legislation and had, instead, encouraged the insertion of the language concerning Citizen's Petitions as a sop to generic drugmakers. A PhRMA spokeswoman declined to comment. As an aside, US Federal Trade Commissioner Tom Rosch last month failed to dissuade the Senate from including the REMS provision in its bill (read his letter here).