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Carol M. Morrissey has been the Legislative Specialist for the Washington, D. C. office of Chicago's Sidley & Austin for 11 years. She is a lawyer and legislative expert who has also authored a Congressional update column for the last 4 years.
(Archived January 1, 1998)
On November 21, 1997 President Clinton signed into law S. 830, popularly known as the Food and Drug Administration Reform bill. The press tends to highlight the negative where Congress is concerned, writing article after article about that which Congress has been unable to achieve (ie: campaign finance reform). The story of the FDA Reform bill is a telling example of how bipartisan support is necessary for the survival and ultimate passage of legislation in the 105th Congress.
Successful legislation is not born in a vacuum. The FDA reform movement has been underway since the GAO began investigating the agency back in 1978. The last major piece of FDA legislation was passed in 1962. The fact that nothing really substantive emerged until 1995 highlights the difficulty of tackling an agency whose decisions touch the lives of every American and whose importance has grown exponentially with each newly developed drug and medical device as well as with the expansion of the food industry. More importantly, the reform movement pits the safety of the consumer/patient against the demands of the market to streamline FDA review procedures.
At the end of the first session of the 104th Congress, Sen. Kassebaum (R-KS), then Chairman of the Senate Committee on Labor and Human Resources, introduced the Food and Drug Administration Accountability Act of 1996 (S. 1477). The legislation sought to streamline the FDA review process and reform the agency. It was supported by the pharmaceutical companies and the manufacturers of medical devices. Consumer organizations saw it as a blatant attempt to cater to special interests by weakening the approval process so new drugs and devices could be developed more rapidly. The bill was reported out of Committee in June of 1996, but was never voted on by the full Senate.
On June 9, 1997 Sen. Jeffords (R-VT), the current Chairman of the Senate Labor and Human Resources Committee, introduced the Food and Drug Administration Modernization Act of 1997 (S. 830), to reform and expedite the drug and device approval process and reauthorize the Prescription Drug User Fee Act of 1992 (see www.senate.gov/~labor/ for press releases and statements on the FDA Reform bill). Of the seven cosponsors of the Act, two were Democrats, Sens. Mikulski (D-MD) and Dodd (D-MA). The ranking Democratic member of the Committee, Sen. Kennedy (D-MA), opposed the legislation.
As the Chairman of the Senate Labor and Human Resources Committee prior to the Republican control of the Senate, Sen. Kennedy had supported, and Congress had passed, legislation to preserve the safety, efficacy and subsequent tracking of medical devices. (See Sen. Kennedy's webpage at www.senate.gov/~kennedy and click on FDA Reform). Now the shoe was on the proverbial other foot and Sen. Kennedy was placed in the position of trying to protect the consumer to whatever extent possible. The Senator held up the bill for months while provisions which he objected to were modified or dropped. He eventually supported the legislation, stating that the" health of the American people would be enhanced through greater and faster availability of pharmaceutical drugs and medical devices."
The resulting legislation includes many provisions which consumer and patient advocate groups find highly objectionable. The medical device provisions expand a pilot program that allows for accredited third party review of most 510(k) devices (which are those that manufacturers claim are"substantially equivalent" to already marketed devices). Risky products, such as artificial heart valves are exempted from the program. The FDA is now allowed to reduce the number of medical devices which it is required to track or the manufacturer must monitor ("unnecessary" reporting and tracking). The FDA's authority to evaluate intended uses and other claims beyond those identified in the proposed labeling has been restricted. The legislation also requires the FDA to meet with manufacturers upon request early in the review process and greatly reduces the post-marketing burden to disseminate certain product information. The FDA has apparently already created an "Implementation Task Force" in order to respond to the new requirements under the legislation. (For watching this particular issue in the future, see the webpage of the Medical Device Manufacturers Association at www.medicaldevices.org for information.)
A "Patients Coalition" which opposed the legislation, composed of such organizations as the Consumer Federation of America, Public Citizen and the National Women's Health Network is currently formulating an action plan to address the passage of the legislation. Many of the provisions of the legislation require the FDA to promulgate regulations in order to be implemented. Advocacy groups intend to closely monitor the regulatory process, providing comments and other input where necessary. Also, the Coalition will monitor legislation to be introduced next session to "clean-up" some technicalities in the final bill. The resolution which was put forth this past session to correct the technicalities failed, the House and Senate having passed different versions and subsequently being unable to reach a compromise. (The Consumer Federation of America does not have a webpage, see Public Citizen's webpage at www.citizen.org/congress/fda/home.html for more information.)
Sen. Jeffords characterized the legislation as a "win-win situation," since it initiates reforms that will help patients receive new therapies sooner without sacrificing safety or the authority of the FDA. It comes as no surprise that the legislation was heavily supported by medical device and drug manufacturers. It means less time and less money for drug and medical device manufacturers to obtain approval of new products, which translates into profits all around. For some industry comment on the legislation, see the page of the Health Industry Manufacturers Association at www.himanet.com (click on FDA Reform) and the page of the Pharmaceutical Research and Manufacturers Association at www.phrma.org/ (click on current news).
With so many diverse interests at stake and so many groups still objecting vociferously to the bill (Howard Metzenbaum, chairman of the Consumer Federation of America called passage of the bill "a dark day for the American consumer") why did it become law? The Clinton Administration was apparently intent on reaching a consensus on this legislation and it was their support which ultimately swayed reluctant Democrats to vote in favor of the bill, warts and all. (The Secretary of Health and Human Services, Donna Shalala did balk at certain provisions, and they were dropped.) It should be duly noted that the FDA does not currently have any information or comment on the legislation available on its webpage - perhaps they are withholding judgment. (For the FDA homepage, see www.fda.gov/fdahomepage.html.)