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Making Drugs Safe and Available without the FDA
Reform Efforts
To reduce drug development and approval times, various administrative and
legislative reforms have been enacted or proposed.
User Fee Act.
The first major reform bill enacted, the 1992 Prescription
Drug User Fee Act, allows the use of unapproved drugs for such serious conditions
as AIDS and cancer before clinical trials are complete. For other drugs,
the act spells out user fees manufacturers can pay to provide resources
that speed up application reviews. It also mandates that the FDA meet goals
for improving its performance. It is required to review progressively higher
percentages of new drug applications within one year - which is still longer
than the statutory six-month limit for reviewing applications.
FDA Initiatives.
Before his resignation in November 1996, even FDA
Commissioner Kessler saw the need for change or at least the congressional
threat to the FDA. Kessler had stated, "[W]e are working hard to make
the FDA more efficient," and "[W]hen it comes to getting needed
therapies to dying patients, the riskiest thing we can do is be unwilling
to take risk."26 Thus in 1994 the FDA exempted from approval requirements
several hundred low-risk medical devices that are substantially equivalent
to devices already on the market.27 By January 1996 the FDA had exempted
a total of 572, nearly three-quarters of the lowest-risk devices.28
In August 1996 the FDA initiated a pilot study of a European-style review
system for low- to moderate-risk devices. For the study, the FDA has accredited
outside reviewers to test the design, performance and safety of at least
10 categories of devices. Unlike the European system, where only certification
by an independent reviewer is necessary before a device is marketed, the
U.S. pilot study requires the outside reviewer to make a recommendation
to the FDA, which makes the final decision.29
Senate Proposal. Sen. Nancy Kassebaum's FDA reform bill S.1477, The FDA Performance and Accountability Act, passed the Senate Committee on Labor and Human Resources on a bipartisan vote of 12 to 4.30 It contained common-sense reforms reining in FDA power and reducing the regulatory burden on manufacturers without substantially altering FDA methods. A revised bill with fewer reforms was reported out of the committee on June 20, 1996. The 104th Congress took no further action but the new Congress may consider similar legislation.
S.1477 would have required the FDA to establish an in-agency appeals system with scientific review groups to examine disputes. It would have required the FDA to allow the use of one clinical investigation, instead of two, to demonstrate the safety and efficacy of a drug.31 It also would have required the FDA to make experimental therapies more readily available to patients. The Senate bill also included provisions for these more fundamental changes at the FDA:32
- Performance Standards. The FDA would be required to develop
and publish quantifiable performance standards for its own review process.
- Product Performance Standards and Reasonable Data Requirements.
The FDA would be required to recognize appropriate device performance standards
set by certified, independent organizations. The FDA also would be required
to establish criteria for data that must be included in applications.
- Scientific Review Groups. The FDA would have to expand its
existing expert review system. The advisory committees would have more independence,
and the FDA would respond to their recommendations in a timely manner.
- Third-Party Review. The FDA would have to establish requirements for a third party to become an outside reviewer. Manufacturers could seek third-party review and recommendation for approval of medical devices. The FDA would then have to accept or reject the third party's recommendation.
The major difference between the Senate bill and the House bills was the role of third-party certifiers. In the House bills, manufacturers could take their drugs or devices to the independent certifier without first seeking FDA approval. The drugs and devices would be assumed approved if the FDA did not respond to the third-party recommendation within 60 days. If the FDA vetoed a recommended approval, it would have to explain why.