Oct. 18, 2002
WASHINGTON, D.C. – Legislation approved Thursday by the U.S. Senate will compromise the U.S. Food and Drug Administration’s (FDA) ability to protect consumers from dangerous medical devices, Public Citizen said today.

The legislation, already approved by the U.S. House of Representatives, is designed to speed up the approval of new medical devices by allowing device companies to partially fund safety reviews, putting pressure on the FDA to approve devices that may be dangerous to patients. The bill also allows private contractors hired by industry to inspect manufacturing facilities for compliance with good manufacturing practices and review some devices for approval – a blatant conflict of interest.

Under the legislation (H.R. 5651), the FDA would agree to a timeframe for the approval of new devices in exchange for the additional industry revenue. The danger of such a program is that it will put pressure on the agency to give the industry’s concerns for speedy approval of devices special attention at the expense of the public’s need for protection from dangerous devices.

This is what appears to have happened as a result of a similar program for the approval of new prescription drugs, the Prescription Drug User Fee Act (PDUFA), enacted in 1992. The rate at which drugs have been approved and then withdrawn for safety reasons has increased in the period after PDUFA’s passage. According to the General Accounting Office, 5.34 percent of drugs approved from 1997 to 2000 were withdrawn for safety reasons, as opposed to 1.56 percent of drugs approved from 1993 to 1996.

The medical device legislation also would create a system in which device manufacturers would designate private contractors to inspect their facilities for compliance with good manufacturing practices and continue a program under which private contractors review some devices for approval. Currently, the FDA conducts all plant inspections. Under H.R. 5651, inspectors and reviewers would be dependent for business on manufacturers who would decide which inspectors or reviewers to hire and how much to pay them. A desire for repeat business on the part of inspectors and reviewers will give them an incentive to go easy on manufacturers. "

This legislation creates a system in which the fox would be guarding the hen house," said Frank Clemente, director of Public Citizen’s Congress Watch. "We should not be entrusting vital public health functions to firms dependant on the device industry for their business.

"Experience with the user fee program for drugs indicates the dangers that come with a user fee program for medical devices. PDUFA, which was reauthorized this year, allows the FDA to collect user fees from drug companies to fund the new drug approval process. Although the average review times for new drugs has dropped since its passage, evidence shows that the FDA may be compromising safety standards in response to pressure to approve new drugs too quickly.

In its study, the GAO noted that seven drugs approved from 1997 to 2000 (Baycol, Raplon, Lotronex, Rezulin, Raxar, Duract, Posicor) have been withdrawn because of safety concerns, as opposed to two drugs (Propulsid and Redux) in the period immediately following PDUFA’s passage (1993-1997).

Further, since PDUFA’s passage, FDA officials have been quoted in the press saying that they feel under increased pressure to approve drugs. And FDA officials have been precluded from presenting data adverse to drug approvals at FDA Advisory Committee meetings. An internal survey of FDA drug review personnel found that one third did not feel comfortable voicing a scientific opinion if it differed from others in the agency. A number of those surveyed felt that drug approval decisions are too heavily influenced by industry instead of science.

If a user fee program for devices is enacted, we can expect the same effect on agency personnel charged with reviewing devices, Clemente said. They will feel increased pressure from the industry and may approve devices that otherwise would not have been approved.

The FDA is required by law to inspect medical device manufacturing facilities for compliance with good manufacturing practices every two years. However, because of inadequate financing, the FDA is able to inspect manufacturers only approximately every five years. This is far too infrequent to adequately protect the public from poorly manufactured devices. The proponents of H.R. 5651’s third-party inspection program argue that it will lead to more frequent inspections. This may be true, but we do not need to follow the approach of this legislation to address the problems of the FDA’s current inspection system, Clemente said.

"Instead of relying on private inspectors, the FDA’s inspection program for device manufacturing facilities should be fully funded by general federal revenues, so there will be no confusion about whose interests inspectors will be serving," said Ben Peck, legislative representative for Public Citizen’s Congress Watch.