FDA Commissioner Gottlieb Forms FDA Working Group Focused on Generic Competition

FDA Commissioner, Scott Gottlieb, MD, has created a new FDA working group of senior agency staff who will investigate ways to increase generic drug competition.

The agency has already taken steps to address what Gottlieb calls “gaming” of the regulatory system by some drug makers who seek to delay the approval of generic drugs. Thus far, the agency has begun work on a Drug Competition Action Plan, held a public meeting on the administration of the Hatch-Waxman Amendments, published a list of off-patent branded drugs that do not yet have approved generics, announced upcoming publication of 2 new documents designed to help generics companies navigate the Abbreviated New Drug Application process, and announced a new policy to expedite the review of generic drug applications.

The new initiative, Gottlieb said on Twitter, will expand upon the goals of the agency’s Action Plan:

The working group will also develop proposals to address ongoing difficulties in administering the Hatch-Waxman Amendments:

Yet the new initiative also seeks to move beyond those current efforts, and to identify new ideas and approaches that will improve access to generic drugs:

BioCentury reports that the working group’s membership includes Elizabeth Dickinson, JD, an FDA attorney in the Office of the Chief Counsel; Grail Sipes, JD, director of the Office of Regulatory Policy at the agency’s Center for Drug Evaluation and Research (CDER), and Maryll Toufanian, JD, deputy director of CDER’s Office of Generic Drug Policy.

The formation of the new working group follows Gottlieb’s recent congressional testimony, during which he highlighted barriers to competition in the pharmaceuticals marketplace. Among the barriers Gottlieb identified were restricted distribution systems and access to drugs for bioequivalence testing; single, shared systems for risk evaluation and mitigation strategies (REMS); citizen petitions, drugs not yet addressed under the 2006 Unapproved Drugs Initiative; and so-called “pay-for-delay” agreements, in which generics companies resolve patent disputes by agreeing to delay market entry in exchange for a sum of money.

Since his confirmation as FDA Commissioner in May, Gottlieb has made drug pricing a focus of the agency’s attention, and the formation of the working group suggests that these efforts to increase competition and drive down drug costs will only continue.