Consumers Blast White House Signing Ceremony for Anti-FDA Bill
WASHINGTON, D.C. — Consumer health advocate Sidney M. Wolfe, M.D. blasted the attempt by the White House and Congress to portray the FDA Modernization Act of 1997 as beneficial to public health, calling it “the worst attack on the Food and Drug Administration?s ability to protect consumers and patients in 91 years.”
Under this legislation, which President Clinton was scheduled to sign into law at a White House ceremony on Friday (Nov. 21), Americans will be exposed to defective drugs and medical devices that Europeans, with their weaker laws, have been exposed to for a long time.
“This bill is good for corporate profits and bad for public health — period,” said Wolfe, director of Public Citizen?s Health Research Group. “Thirty-four million dollars in political contributions from the drug and medical device industries smoothed its way through Congress. President Clinton’s signature is deeply injurious. Calling it ?pro-patient? in the face of the strong opposition of a large number of national consumer, patient and public health groups adds insult to injury.”
Wolfe identified the “10 worst provisions” of the legislaton as:
1. Allowing drug and medical device companies to promote their products for unapproved purposes. A letter co-signed by 79 national medical educators urged Clinton to oppose this unprecedented breach of U.S. approval standards, which have required manufacturers to prove their product safe and effective for a particular use before marketing.
2. Permitting medical device manufacturers to select, negotiate terms with, and directly pay private for-profit firms to review their products instead of the FDA’s objective professional staff.
3. Lowering the passable number of clinical investigations required to establish a drug or medical device’s safety and effectiveness from two or more such studies to one or more.
4. Making tracking and post-market surveillance of very high risk medical devices such as heart valves optional rather than mandatory.
5. Reducing the frequency of medical device adverse incident reporting and substituting reporting by a statistical subset of device user facilities for reporting by all.
6. Allowing pharmacists to compound drugs in bulk exempt from FDA safety, effectiveness and good manufacturing practices standards.
7. Giving drug and medical device companies a privileged position in the regulatory process compared to consumers, patients and healthcare practitioners by stacking the membership of advisory panels in their favor and giving them special status and appeal rights.
8. Shifting the burden of proof and the requirement to initiate action from the manufacturer to the FDA at many points in the review process for drugs and medical devices – without giving the FDA additional funds to hire staff to do the job well.
9. Nullifying state consumer protection laws for over-the-counter drugs and cosmetics if there is any federal regulation, no matter how weak, in place for that product. Except for California’s Proposition 65, preventing states from enacting consumer right-to-know legislation.
10. Failing to give the FDA the enforcement tools it lacks — and badly needs — to effectively regulate the powerful drug, medical device and tobacco industries. Subpoena power, administrative recall authority and the ability to levy civil monetary penalties were kept out of the legislation by industry opposition.
“The drug and medical device industries held the reauthorization of the Prescription Drug User Fee Act (PDUFA) hostage to their special interest agenda all year,” Wolfe noted. “Finally, PDUFA slipped from their grasp when it was reauthorized for one year as part of the Agriculture Appropriations Act.
“Now that PDUFA is free, President Clinton should veto S. 830 instead of rewarding drug and device industry extortionists with his signature. But if he chooses to sign this special interest legislation, he ought to at least have the decency to call it what it is — a bill that puts private wealth above public health; a bill that will expose patients and doctors to far greater risk that the drugs and medical devices they rely on are unsafe or ineffective; a bill that more than 100 national consumers, patients and public health groups strongly oppose.”