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Eliminate FDA’s Dependency on Drug Industry Money, Public Citizen Tells Congress

May 4, 2007

Eliminate FDA’s Dependency on Drug Industry Money, Public Citizen Tells Congress

Letter Urges Lawmakers Not to Reauthorize the Prescription Drug User Fee Act

WASHINGTON, D.C. – Congress should not reauthorize the user fees at the core of the Prescription Drug User Fee Act (PDUFA) because of the unacceptable conflicts of interest the fees create at the Food and Drug Administration (FDA), Public Citizen said today in a letter sent to all members of Congress. The organization urged lawmakers to abolish the user fee system and resume funding this critical public health function entirely from the federal treasury. However, the letter stated that this should not preclude the passage of various amendments currently being considered by Congress that would strengthen the agency’s drug safety functions.

As the gatekeeper for America’s prescription drug supply, the FDA is tasked with reviewing all prescription drug applications. This work can be done only by an agency that is beholden only to the public and cannot be swayed by the business concerns of companies seeking product approval. But the current bill, S. 1082, would allow for one-fifth of the FDA’s budget, $393 million, to come from user fees from pharmaceutical companies. This is up from $305 million in fiscal year 2007, and would force the FDA to become even more dependent for its funding on the very industry over which it has regulatory authority.

Since PDUFA was passed in 1992, the FDA has treated the drug industry more as a stakeholder and client than a business to be regulated. The result has been a decline in safety standards at the FDA and a record number of drug withdrawals – totaling more than a dozen – for safety reasons. In 2002, the General Accounting Office found that a higher percentage of drugs had been pulled from the market due to safety concerns after PDUFA was passed.

“User fees have left behind a trail of banned drugs – and patients who have been needlessly killed or injured by them,” the letter states.

Numerous scientists, regulatory experts and senior FDA staff oppose the user fee program and have concluded that the money saved by taxpayers through industry funding of the FDA is insignificant compared to the injuries and deaths caused by dangerous drugs allowed onto the market.

“Although the almost-$400 million in user fees now sought in some PDUFA reauthorization bills is critical to the agency, it is not a sum that would make much of a dent in the federal budget,” the letter concludes. “We urge you to return the agency’s funding source to those to whom the agency is supposed to be accountable: the American taxpayer.”

The letter was written by Dr. Peter Lurie, deputy director of the Health Research Group at Public Citizen; Laura MacCleery, director of Public Citizen’s Congress Watch division; and Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen. To read the letter, click here.