FDA’s Woodcock to Congress: Pass the GDUFA and BsUFA Reauthorizations

Regulatory NewsRegulatory News | 02 March 2017 |  By 

Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, was in the hot seat on Thursday taking questions from the House Energy & Commerce Committee and urging the representatives to pass re-authorizations of the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA).

While stressing the successes of the first GDUFA, Woodcock told the committee that this next iteration will provide more funding to FDA for even faster generic drug reviews (in some cases there will be eight-month priority reviews) and more interactions between the agency and generics developers working on complex generics. The details of both the GDUFA and BsUFA re-authorizations have already been agreed to and need to be signed off on by Congress before the end of September so that FDA, over the next five years, can continue to receive the necessary funds to ensure the products are reviewed in a timely manner.

When the conversation with the committee on Thursday shifted to rising pharmaceutical prices, Woodcock noted that currently there are 182 drugs that no longer have patent protection but also do not have any marketed generics. She also said there were more than 500 drugs with only one marketed generic but that FDA prioritizes the reviews of such sole-source generics.

When asked why there are so many drugs without patent protection or competition, Woodcock said she believes it is because of the low return on investment for companies in the generic industry.

But Woodcock also made clear that FDA cannot speed up the review of generic drugs too much faster than this eight-month timeline because of the need to schedule and inspect manufacturing facilities.

A reorganization of FDA’s field force via its Office of Regulatory Affairs is also expected to come in May, Woodcock added, noting that reorganization will mean more inspectors that only work on pharmaceuticals, "so we hope to have a close relationship with them and worked out a new process and hope that the payoff is more consistency on how they operate."

On the biosimilar side, FDA has approved four biosimilars over the past two years but significantly more are expected. Woodcock said the agency is working on 64 biosimilar development programs that will provide competition for 23 biologics.

She also made clear FDA is working to further educate the generic and biosimilar industries on how to improve their applications, which on the generic side often go through multiple cycles at the agency and linger for years. But often these generic delays are necessary, she said, offering examples of bad actors switching test samples so results look positive and other cases where drugs were released based on made up specifications.

Testimony of Janet Woodcock

Examining FDA’s Generic Drug and Biosimilar User Fee Programs


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