Commissioner Scott Gottlieb recently announced the formation of a new working group for the Food and Drug Administration (FDA). The group will focus on modernizing the Hatch-Waxman Act and promoting competition and access to generic drugs, and it will examine many different issues in order to promote that competition.
In his announcement, Gottlieb described the goal of the working group as “to think beyond our current policy proposals; find new ideas for greater generic drug access.” Members of the group include Elizabeth Dickinson (FDA attorney and former Chief Counsel), Grail Sipes (director of the Office of Regulatory Policy at the Center for Drug Evaluation and Research) and Maryll Toufanian (deputy director of the Office of Generic Drug Policy).
The FDA’s working group will focus on several areas. The members will likely look at REMS (risk evaluation and mitigation strategies) that brand companies abuse to prolong negotiations and to extend exclusivity periods for their drugs. Members of Congress have already introduced a bill, the CREATES Act, to put an end to these abuses. The working group will also probably promote greater knowledge of the requirements to get abbreviated new drug applications (ANDAs) approved and to make it easier for drug-device combinations to be approved.
Additionally, the group could examine how ANDA applications are prioritized and make reforms. Two of the proposed options are promoting increased competition among existing generic drugs to dramatically lower prices, or encouraging development of generic drugs in situations where there are only brand drugs and no generic competitors. Finally, the group will likely focus on citizen petitions, which are abused by brand drug companies to delay generic drugs. The FDA accepts less than 10% of citizen petitions, and it could impose penalties on companies that file frivolous petitions.
This working group is not the first step the FDA has taken in recent weeks to promote generic drug access. It has started work on a drug competition action plan, held a July 18th public meeting on abuse of regulations and generic drug access (where we gave a presentation), published a list of off-patent branded drugs that don’t yet have approved generics, announced the publication of two new documents to help companies get through the drug approval process, and issued a new policy to promote faster review of generic applications.
While the FDA has limited authority to affect drug prices, it can promote generic drug competition and access, and we are pleased that it is taking such an active role.