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FDA Proposes New User-Fee Program For Generic Drugs February 5, 2007

Posted by notapundit in US News.

WASHINGTON (Dow Jones)–The White House’s 2008 budget request for the Food and Drug Administration includes a proposed separate fee program for generic drug makers to help the agency deal with an increasing number of generic drug applications.

The overall FDA budget request seeks $2.1 billion in fiscal year 2008, an increase of $105.8 million from the 2007 request, or a 5.3% increase for the agency. The FDA also charges pharmaceutical companies a fee when they submit applications for the agency to review new brand-name drug and medical devices. The 2008 fiscal year starts Oct. 1.

The FDA said it received 307 applications for generic drugs in 2002 and 753 in 2006, and that it can act on 55% of applications within 180 days.

The agency is seeking $5.6 million in appropriations from Congress and $15.7 million from the proposed user-fee program to hire 34 more people to review generic-drug applications in order to boost the amount of applications it can review within six months.

However, the Generic Pharmaceutical Association, which represents generic drug makers said user-fees won’t bring generic drugs to the market any faster. While the association said it’s open to discussion, any legislation would also need to address other “barriers” such as petitions filed with the FDA that can be used to delay entry of generic drugs to the market and the marketing of authorized generic drugs by the original brand-name manufacturers.

The budget request also includes a $10.6 million increase to fund various food safety initiatives, including the development of better methods to detect and find the source of outbreaks of food borne illness. The FDA noted that recent illnesses associated with spinach and lettuce at Taco Bell restaurants “highlight the need for increased resources to strengthen food safety.”

The agency is also requesting an increase of $11.2 million to fund drug-safety programs, including hiring more people to evaluate public and private databases that contain information about side effects.

The FDA is also seeking $21.8 million to fund cost-of-living increases for FDA employees and $42.9 million to pay for the agency’s continued consolidation into one location near Silver Spring, Md. The agency currently has offices in several locations in Montgomery County, Md.

By Jennifer Corbett Dooren, Dow Jones Newswires


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