FDA fees rise in latest budget

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FDA WASHINGTON -- The Bush administration yesterday proposed about a $100 million increase in the Food and Drug Administration's budget for fiscal 2008 that includes the first user fee for the generic drug industry as well a big boost in fees paid by brand-name pharmaceutical companies.

The FDA said the budget increase will be devoted to improving the screening and safety of new drugs; stepped-up oversight of medical devices; strengthening of food safety in light of recent food- borne outbreaks; and more timely reviews and approvals of lower-cost generic drugs.

The President's blueprint calls for $2.1 billion in overall FDA spending during fiscal 2008, up from a projected $2 billion for the current fiscal year.

"As the FDA enters its second century of service, our focus will continue on critical public health initiatives, including ensuring the safety of the food we eat and the safety and effectiveness of the medicines we take," FDA Commis sioner Andrew von Eschenbach said.

But William Vaughan of Consumers Union said the budget increase just about equals inflation, and does not include the large ex pansion called for by a recent Institute of Medicine report that found a lack of money and staff hamper the FDA's ability to properly monitor drug safety and protect the public.

The FDA said it will increase its food safety budget by $10.6 million; drug safety operations by $11.2 million; and medical device oversight by $7.2 million.

The proposed budget includes nearly $444 million in fees from in dustries the FDA regulates, including the proposal to charge makers of generic drugs $15.7 million annu ally to review their applications for their new products.

It also includes a plan to collect an additional $23 million from laboratories and facilities that fail to meet health and safety standards and must be reinspected.

The White House said the new $15.7 million in fees from generic drugmakers will "enable FDA to reduce review times and respond to a growing number of generic drug applications."

The Generic Pharmaceutical Association neither embraced nor flatly rejected the user fee plan, but disputed the notion that it would speed drugs to market.

"The Bush administration's decision to include user fees in its 2008 budget will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry," said GPhA President and Chief Executive Kathleen Jaeger.

Jaeger said the generic industry is "open to discussing options," but added that hiring more drug reviewers by itself will not eliminate obstacles to wider generic use.

Generics represent 56 percent of the total prescriptions dispensed in the United States, but less than 13.1 percent of all dollars spent on prescription drugs.

The FDA budget also includes a plan negotiated with the major brand-name drugmakers that calls for an $87 million increase next year in industry fees, to $393 million. This money will be used for stepped-up monitoring of side ef fects of drugs after they have reached the market, as well as increasing the number of employees that will review new drug applica tions.

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