In the last few years, the GAO has criticized the FDA for failing to protect our food supply, assure the quality and safety of drugs produced abroad and detect emerging adverse event trends in post-marketing drug surveillance.
So forgive those who barely batted an eye when the GAO called out the agency once again last week, this time for fumbling its fundamental responsibility to assure the safety and efficacy of medical devices.
That pacemaker your Uncle Harry received last week? Almost certainly, it received nothing more than casual look-see from the agency.
The FDA approval process begins by assigning medical devices to one of 3 classes which in turn drives the degree of regulatory scrutiny they recieve.
Reading glasses, tongue depressors and the like are Class I devices, usually exempt from review. Mercury thermometers are Class II, worth at most a quickie.
Class III devices include the good stuff: pacemakers, MRI machines and heart valves for example.
But according to a Congressionally approved 1976 process, Class III products also receive perfunctory reviews if they are found to be essentially similar to devices already on the market.
Or, as Memorial Sloan Kettering physician Peter Bach told the New York Times. “The manufacturer wheels in their new Ferrari and says, ‘Look, it’s just like the Model T,’ ” which is essentially enough to guarantee FDA approval.
“Then they say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without (necessarily improving) outcomes,” Bach told the New York Times.
In its report, the GAO emphasized “it is imperative that FDA take immediate steps” to put a more rigorous approval process in place for medical devices.
FDA officials insisted to GAO investigators that updating the rules was a priority. But “when asked for their time frame for doing so, the officials did not provide one,” according to the report.