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Drug safety reforms urged in FDA user-fee proposal

67% Americans Concerned About Drug Industry Funding FDA; Drug-Safety Reforms Urged in User-Fee Proposal

CU testifies Tuesday at House hearing on PDUFA reauthorization

Click here to read Vaughan’s complete written testimony.
(Washington, D.C.) – Consumers Union will testify Tuesday before the House health subcommittee that more than two-thirds of Americans are concerned that much of the Food and Drug Administration’s funding comes from the pharmaceutical industry, and that 8 in 10 agree the drug industry has too much influence over government regulators.
“The public knows that whoever pays the piper calls the tune, so when the drug industry funds the Food and Drug Administration, that’s not good government,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.
The House Health Subcommittee is considering renewal of the Prescription Drug User Fee Act, passed in 1992 to speed up drug approvals by having the industry help fund the approval process. The proposal calls for industry to pay $393 million annually to FDA.
A new Consumer Reports poll released this week found that 67 percent of consumers are concerned that much of the FDA’s funding comes from the drug industry, with 54 percent “very concerned” about that financing arrangement. It also found that 84 percent of consumers agree that the drug industry has too much influence over regulators. Click here to learn more about the poll
Vaughan said if budget realities require industry user fees to keep the FDA operating, the funds should be put in the general Treasury and re-distributed to the agency (HR 2090, Rep. Hinchey) without industry-set performance goals or strings attached.
“The user fee arrangement damages the image, morale and public service culture of the FDA, and ultimately damages the public because it compromises the safety of the drugs we rely on,” Vaughan said. “The industry funds should not have strings attached.”
Click here to read Vaughan’s complete written testimony.
Vaughan also said that PDUFA should not be reauthorized this year without significant reforms in drug-safety laws, as well as more dedicated funding to drug safety. PDUFA legislation should include safety deliverables similar to those in HR 1561, the Waxman-Markey bill, giving the FDA increased authority to act on unsafe drugs, and the ability to hold drug companies accountable when they don’t perform requested safety studies or other measures.
“Congress should match the high-speed of drug approvals it provides the industry with a high-speed, high-quality safety system that makes sure the drugs we take each day are as safe and effective as possible,” Vaughan said. “If drug-safety reform legislation is not included in this user-fee package, we will miss a huge opportunity to protect Americans from unsafe drugs.”
For more information, contact Susan Herold, Bill Vaughan, 202-462-6262