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Sid Wolfe Opposing the Killer Phen-Fen Amendment

June 9, 1997

The Honorable Jim Jeffords
Senate Labor and Human Resources Committee
430 Dirksen Senate Office Building
Washington, DC 20510

? RE: S. 830, the “Food and Drug Administration Modernization and Accountability Act of 1997”

Dear Senator Jeffords:

I am writing to express our strong opposition to S. 830, the FDA legislation you introduced on June 5.

Proponents of S. 830 are attempting to characterize this year’s bill as a moderate, consensus, “modernization” measure. Nothing could be further from the truth.

S. 830 is in many ways even more damaging than last year’s bill. It would substantially weaken the FDA’s ability to protect public health by:

1. Lowering the standard to prove drugs and medical devices safe and effective by:

– Weakening the definition of what constitutes “substantial evidence” of effectiveness for both drugs and medical devices by changing the statutory presumption that one clinical trial instead of two would be adequate (see attached Washington Post editorial);

– Eliminating the requirement that a supplemental use be scientifically proven effective before drugs can be marketed on-label for that use; and

– Limiting the FDA’s authority to review medical devices’ for safety and effectiveness to the specific use proposed in the manufacturer’s labeling, even in cases where the product appeared likely to be used for broader purposes.

2. Introducing inherent conflict-of-interest into the medical device review and approval process by establishing a system of third-party review for Class I and Class II devices, even for those in the latter category that require clinical trials:

– Instead of submitting their products to the FDA for review of safety and effectiveness, manufacturers could themselves choose their reviewer from an FDA-supplied list; and

– Terms and amount of payment would be negotiated directly between the manufacturer and the reviewer. The decision whether to use that reviewing firm again would be the manufacturer’s.

3. Repealing mandatory device tracking and postmarket surveillance, two essential components of the postmarket “early warning system” for medical devices, that were placed in the law in 1990 in response to preventable tragedies caused by faulty devices.

S. 830 doesn’t stop there:

– Under the guise of making new drug therapies for critically ill patients and humanitarian devices more readily available, the bill would permit drug and device companies to widely sell experimental drugs and devices.

– It would authorize drug companies to make unproven “health economic claims” about their products to large purchasers such as HMOs. There are no standards to wall off claims about “economic” benefits from claims about unproven “safety and effectiveness” characteristics.

– It would shift the FDA’s role in the medical device review process from that of a “regulator” to a “collaborator.” For example, FDA staff would be mandated to inform medical device companies in writing how their applications should be drafted in order to insure that their products would “require an approval.” Reviewers would be instructed to use the “least burdensome” method to the manufacturer, rather than the method that best protects the public health.

– The bill would exempt recognition of national or international standards from the Administrative Procedures Act. This provision could be used to permit weaker international standards to supplant U.S. public health protections, without even the safeguards of public notice and the right to comment.

Despite the fact that S. 830 seriously weakens the Food, Drug, and Cosmetic Act, which is one of the most important public health and consumer protection laws in the U.S., no case has been made for why these changes are necessary. There has been no public hearing on the bill, and none is scheduled; mark-up without a hearing is set for Wednesday, June 11.

This legislative fast track is being justified by the fact that S. 830 links these major, controversial changes in law to the unrelated issue of reauthorizing the Prescription Drug User Fee Act (PDUFA). We support the timely reauthorization of PDUFA, which has successfully expedited the review and approval of new drugs. But there is no reason for Congress to rush consideration of the other major changes in the bill.

What is needed, but missing from the bill, are measures to strengthen the FDA’s enforcement powers. Among the items we favor are subpoena power for drug and other related industry records; civil monetary penalties for any drug-related violation of the Food, Drug, and Cosmetic Act; broadening FDA inspection authority to include over-the-counter drugs; and giving the FDA authority to require mandatory recalls, be promptly notified of voluntary ones, and inspect drug testing laboratories.

We urge you to reconsider this one-sided and harmful legislation and to limit the legislative fast track to reauthorizing PDUFA.

If you have any questions, please call or have your staff contact me at 588-7735 or Legislative Advocate Maura Kealey at 546-4996 ex.371.


Sidney M. Wolfe, M.D.

Director, Public Citizen Health Research Group




Washington Post editorial, “An FDA with Teeth,” June 9, 1997

“Popping Contributions: The New Battle for the FDA,” The American Prospect, July – August 1997