›FDA Commissioner, Generic Drug Executives Support Industry Fees
FEBRUARY 18, 2011, 12:35 P.M. ET By Thomas Gryta
NEW YORK (Dow Jones)--U.S. Food and Drug Administration Commissioner Margaret Hamburg backed the idea of drug companies paying fees on their product applications, a move that would provide more resources for their review and help relieve a huge backlog of generic drug applications.
Hamburg's speech at the annual meeting of the Generic Pharmaceutical Association in Orlando, Fla., comes as the agency's Office of Generic Drugs is dealing with a backlog of thousands of applications and the average time to get approval of a generic exceeds two years.
Such a fee structure would be similar to that used for branded drug companies, which pay a stipend for product reviews, under the Prescription Drug User Fee Act that gives substantial resources to the agency in exchange for stable decision timelines on a marketing application.
The makers of generic drugs have indicated a willingness to help the agency increase the speed of not only reviewing applications but also for increasing overseas inspections of manufacturing facilities at foreign drug makers.
"We are willing to step up and pay fees to give the FDA the resources that are necessary," said Heather Bresch, president of Mylan Inc. (MYL).
The FDA plans to meet with industry representatives on the subject later this month. Bresch said the changes will likely take 12 to 24 months to complete and will likely require the involvement of Congress.
Hamburg stressed that it is a "critical time" to make changes to the review of generic drugs, which make up more than 70% of all U.S. prescriptions. The FDA won't be able to make ends meet under its current funding, she said, and that will lead to more applications being delayed.
"Uncertainty and delays are costly to consumers, costly to industry and hurtful to the public's health," she said. "Without generic use fees, we simply cannot achieve for the public what we otherwise could."
She said the FDA looks forward to "building up capacity" to ensure that generic drugs are able to come to the market in a timely manner. She added that the agency would begin discussions in the coming months for creating a user fee for biosimilars, which are essentially generic versions of complex biologic drugs.
Hamburg's appearance immediately followed a panel discussion of generic industry CEOs who threw their support behind the measures. Executives appearing included those from Watson Pharmaceuticals Inc. (WPI), Teva Pharmaceutical Industries Ltd. (TEVA), Momenta Pharmaceuticals Inc. (MNTA), Actavis Inc. and Novartis AG's (NVS) Sandoz unit.
Mylan's Bresch said that proper inspections, along with data collection on imported drugs, can help ensure that "all drugs being sold in the United States meet the same standards."
A government report in 2010 said about 64% of 3,700 foreign drug facilities may never have been inspected by the agency, and the number of overseas inspections remains far lower than those done in the U.S.
Plant inspections are a contributor to the application delays because the FDA must certify that a factory is following good manufacturing practices. Hamburg agreed that more inspections are necessary and that generic facilities need to be reviewed as often as those that make branded drugs.
The enacting of a user fee program for generics would allow for regular inspections, she said, something that should quicken the application review because the FDA "may not need to conduct another inspection" to approve the product.‹
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