Very soon a bill (S. 830) that would effectively gut the federal Food and Drug Administration's (FDA) ability to assure the safety and effectiveness of prescription medications and medical devices will come to the floor of the U.S. Senate. Please call your senator as soon as possible as the bill may be set for a vote as early as Thursday, July 24th, but could be delayed until early the following week. The message: a simple and resounding "Vote No!" See detailed talking points below.
Right wing Republican members, captive to corporate campaign funding, have marked S. 830 as a top priority for passage in this Congress. It is being rammed through Congress while the public is distracted by other issues; not a single hearing has been held on this proposal which has the potential of affecting every single American medical consumer! (Only "informational" hearings were held on the FDA review and approval process, not on the bill before us.) Typical for this right wing-led Congress is its contempt for public debate and avoidance of careful scrutiny of legislation which so obviously caters to profit-making interests.
The bill, deceptively entitled the Food and Drug Administration Modernization and Accountability Act of 1997, would turn over to manufacturers key responsibilities that should rightfully be held by a publicly-accountable governmental agency, like the FDA. The people who stand to profit the most from sales of their products will be making life and death decisions about which drugs and devices are safe for you and your family to use! Your immediate assistance is needed to oppose this legislation, which poses a serious threat to women who, by and large, utilize more prescription medicine. We know how important a strong regulatory system is from past public health tragedies such as the Dalkon Shield which maimed thousands of American women and the DES fertility drug that produced reproductive system deformities in thousands of daughters of DES users.
One very serious drawback of the proposed legislation is the "third party" review of new devices -- like highly complex digital mammography equipment. Companies would hire evaluators from an FDA-approved list, pay (and presumably influence) the for-profit reviewing firms and then submit the results to a constrained FDA approval process in which very little independent scrutiny is possible.
Among the bill's major flaws are the following provisions:
A special problem exists in that a number of Democratic senators who ought to be opposing this bill are prepared to support it even though it is obvious that the legislation undermines important public health protections. Why these usually consumer-oriented senators would support S. 830 is unknown, except several of them are up for re-election in 1998 and at least one of them aspires to run for president. There is a perception that the public mood has swung to the right on many issues, even though this is yet to be demonstrated in the area of public support for food and drug regulation.
Senators who especially need to hear from activists include Barbara Mikulski, Tom Harkin, Jim Jeffords, Patty Murray, Ted Kennedy, Ron Wyden, and Christopher Dodd -- but all Senators should get the message that you will not tolerate their willingness to seriously compromise women's health and safety. Activists should note: If this bad bill is passed by the Senate, an even more dangerous version will emerge from the more extremist House.
Please be advised that a stealth amendment will be offered from the floor. Known as the "killer fen-phen amendment", the proposal would make it legal for companies to promote drugs and medical devices for unapproved uses. This is an especially bad idea, backed by the American Medical Association (the same folks who backed the D & X abortion ban bill), which would permit the prescribing of drugs in untested combinations. The fen-phen (fenfluramine) combination, used for weight reduction, produced damage to heart valves in 33 women and potentially in several hundred other unreported cases. Six of those women needed open-heart surgery to repair the damage.
1. Not a single major provision of S. 830 enhances public health or increases consumer protections (except for re-authorization of the Prescription Drug User Fee Act - PDUFA) S. 830 is both unnecessary and dangerous. Women, especially, stand to be hurt by a poorly regulated pharmaceutical industry.
2. Rather than lowering standards for FDA review and approval, these should be strengthened. There is no reason to believe that the public interest will be protected by removing regulatory authority from a public agency and turning it over to for-profit drug manufacturers -- which is exactly what S. 830 does.
3. The idea that companies' contracting with their own reviewers will produce rigorous evaluations of medical devices is absurd. The built-in conflict of interest is obvious and simply not acceptable.
4. Strict postmarket monitoring and enforcement programs are absolutely essential for tracking medical devices and should be maintained, not undermined as S. 830 promises to do.
5. False and hyped claims for drugs and other products make it difficult for consumers to exercise informed choices. The removal of prohibitions against false claims is a bad idea and will expose poorly informed consumers to exploitation.
6. The legislation will reverse nearly a century of consumer and medical safety progress and will result in a chaotic and unsafe market where "Consumer Beware!" is the watchword. The United States has one of the best drug and medical device review and approval processes in the world. It should be maintained.
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