Bills OKd to Accelerate FDA Approval Process

Swiftly following action by the Senate, the House on a voice vote Tuesday resoundingly approved legislation aimed at streamlining the Food and Drug Administration’s approval process for new drugs and medical devices.

Like the Senate bill, the measure establishes new programs to try to accelerate the review of experimental medical devices and drugs, as well as to expand the access of unapproved therapies to desperately ill people who have no other alternatives.

The two measures also would renew the popular Prescription Drug User-Fee Act, a popular program in which drug companies contribute to a fund used to hire extra personnel to prevent drug-review logjams. The program already has resulted in a speedup in the agency’s review process.

The one significant difference between the House and Senate versions involves the question of unapproved uses of medical devices.

The House bill would permit the FDA to determine if a medical device is likely to be used for a purpose other than declared on the label. If so, and if that use is found harmful, the agency can require the maker to specify that the product is not authorized for the secondary purpose.

The Senate bill would prohibit the agency from reviewing so-called off-label uses of devices. That provision had delayed Senate action on the legislation for weeks and prompted a veto threat by President Clinton.

A statement from the administration hailed the change made by the House. As a result, it said that the bill “represents a significant step toward accomplishing the mutual goal of assuring the [FDA’s] optimum performance while protecting the health of the American public.”

A conference committee of House and Senate members now must resolve the differences between the two bills.

Efforts to change the FDA initially were spurred by the 1994 Republican takeover of Congress. GOP leaders accused several public health and safety agencies, including the FDA, of “over-regulation.”

Attempts to pass a tougher bill--which many Democrats and public interest groups maintained would weaken the FDA--fizzled during the last session.

Rep. Henry A. Waxman (D-Los Angeles) was one of those steadfastly opposing efforts to reform the FDA in ways that he believed would hurt the agency. Commenting on the current House bill, he said that it was “a compromise that makes no one completely happy.”

More effusive about the bill was Rep. Thomas J. Bliley Jr. (R-Va.), chairman of the House Commerce Committee. “We have built a stronger, better, more efficient FDA,” he said. “We’re going to help a lot of people. Medicines will be approved faster. Medical devices will reach people faster. When you’re sick, when you’re suffering, every minute counts.”

Both the Senate and the House measures attempt to address this by expanding a pilot program to allow most experimental medical devices to be reviewed by outside experts chosen and paid for by the manufacturer. The FDA, however, would certify these reviewers in advance and make final decisions.

Also, these outside reviewers would not be permitted to review the riskiest devices, such as heart valves and other implantable items.

The two measures would give terminally ill patients access to experimental drugs and devices that are still under study, even if the patients are not part of formal clinical trials or do not qualify for such studies.