The Food and Drug Administration has created a "regulatory Frankenstein that it has no hope of controlling" and has failed to protect the public from defective medical devices ranging from pacemakers to tampons, a House subcommittee charged in a report being released today.
The report said that the implementation of the Medical Device Amendments of 1976 has been "astounding" because the FDA designated so many devices to be regulated that it could not possibly complete the work necessary to regulate them all.
"It can be fairly concluded that. . . the agency has known it was creating an impossible situation for itself . . . ," the report said.
The FDA had no comment on the report. But a spokesman noted that officials have publicly criticized the law regulating medical devices and have advocated changing it.
The law required the FDA to establish a system through which companies could report deaths, illnesses and other adverse reactions from medical devices, to classify devices according to three categories of hazard, and to establish standards of safety and effectiveness for devices when the agency deemed it necessary.
But after seven years, the report said, the FDA has failed to carry out any of the three key features of the law. It said:
* No adverse-reaction reporting system has been proposed, although an agency spokesman said that one may be proposed soon.
* Of the 41,000 medical devices to be classified, only about 800 have received final classification.
* No safety and effectiveness standards have been established for any of more than 1,000 devices that the FDA has said need such standards.
The subcommittee's investigation turned up "shocking examples of bureaucratic ineptitude and neglect" that exposed the public to "unnecessary risks," said Rep. John D. Dingell (D-Mich.), chairman of the House subcommittee on oversight and investigations, which produced the report. At the same time, he said, the FDA has denied Congress access to critical information to assess those risks.
The FDA tentatively has classified about 1,100 devices as those that need to be regulated, but that do not need to be approved by the agency before they go on the market. But some FDA officials, including John Villforth, director of the agency's National Center for Devices and Radiological Health, have said that it will take 44,000 worker-years to establish standards for those devices, not to mention the 40,000 devices that have not yet been classified.
The report suggested that the law could be made more flexible, but criticized the FDA for its "astounding lack of action" and its failure to consult with Congress to seek solutions.