FDA's Hamburg Calls for Generic-Drug User Fees

US Food and Drug Administration Commissioner Margaret A. Hamburg spoke at the Generic Drug User Fees Public Meeting last Friday, Sept. 17, 2010, about enacting user fees for the generic-drug sector. The agency called the meeting to gather public input on the development of such a program.

Although more than 70% of the prescriptions written in the United States are for generic drugs, the approval process for these drugs faces many challenges, she told the audience. For example, there has been a significant increase in abbreviated new drug applications (ANDAs) submitted to the agency for review. The number of new and foreign ANDA applicants has grown as well, and generic-drug applications are increasingly including “more complex dosage forms.”

The generic-drug sector’s growth has potential to strain the agency’s review system, and there is a chance that the agency will not be able “ to assure that generic versions of drugs are ready to be distributed to American consumers on the first day that they may legally be marketed,” said Hamburg at the meeting. “I want to be clear: we are not in crisis now. But we may soon be…. We need the resources to promote the health and well-being of all Americans. And we need them as soon as possible.”

The solution proposed is generic-drug user fees. User fees are already collected for innovator prescription drugs, medical devices, and veterinary drugs (including generic versions). Hamburg noted that Congress provided the agency with $10 million to address the ANDA backlog (50 additional scientists were or are being hired), but more resources are still needed.

She also stressed out that generic-drug user fees could help advance regulatory science by providing FDA with the capacity to issue additional guidance and standards for the generic-drug sector.  “Above all, though, there must be commitment and collaboration from both our agency and the generics industry,” concluded Hamburg. “ We hold a joint stake in moving our respective efforts forward and developing a well-constructed Generic Drug User Fee Program.”

The Generic Pharmaceutical Association (GPhA) presented at the meeting as well and released a statement in support of a user-fee program. “We are eager to continue working with the agency in developing a user fee program that provides increased certainty in the generic application review process. This includes assuring timely inspections and expanded opportunities for communications between industry and FDA,” said GPhA’s Vice-President for Regulatory Science Gordon Johnston in the statement.

FDA and industry negotiations about a generic-drug user-fee program are ongoing. Comments on the agency docket are due Oct. 17, 2010.  In related news, the agency and industry are also working on reauthorizing user fees for innovator drugs under the Prescription Drug User Fee Act (PDUFA), version V. PDUFA version IV is set to expire in September 2010.