FDA Reform Bill in Congressional Committee

WASHINGTON—The House and Senate have each passed bills revising the process by which the Food and Drug Administration approves new drugs and medical devices. But what happens in the conference committee that resolves a significant difference between the two measures may well decide whether President Clinton signs or vetoes the final bill.

For the most part, the House and Senate reform bills contain similar provisions aimed at streamlining the FDA’s operations and practices. These include creating a fast-track approval system for drugs aimed at serious illnesses, allowing doctors greater access to experimental drugs to treat patients with life-threatening diseases, and permitting independent reviewers to study new medical devices.

The major difference between the two bills lies in the authority they give the FDA in dealing with certain medical devices, such as biopsy needles.

The Senate measure would prevent the agency from testing medical devices for uses other than those the manufacturer claims on its labeling. Consumer groups contend that this strips the FDA of any power to move against dangerous off-label uses.

The House version would allow the agency to request additional data and warning labels if it appears likely the devices might be used for potentially harmful purposes.

White House staff have expressed concern about the Senate bill and indicated that President Clinton would veto the final measure if it contains the Senate version of the medical device provision.

Both bills also would reauthorize the 5-year-old Prescription Drug User Fee Act. This allows pharmaceutical companies to pay extra fees that enable the FDA to hire additional drug reviewers and thus cut the time needed for approval.

Although members of both political parties portrayed the bills as significantly reforming the FDA’s regulatory processes, some observers see them adding little to the reforms initiated in recent years by the agency itself.