Friday, January 16, 2009

GAO Criticizes FDA

The New York Times reports that the Government Accountability Office recently criticized the Food and Drug Administration's device approval process. Here's an excerpt:

Created in 1976, the F.D.A.’s process for approving devices divides the products into three classes and three levels of scrutiny. Tongue depressors, reading glasses, forceps and similar products are called Class I devices and are largely exempt from agency reviews. Mercury thermometers are Class II devices, and most get quick reviews. Class III devices include pacemakers and replacement heart valves.

Congress initially allowed many of the Class III products to receive perfunctory reviews if they were determined to be nearly identical to devices already on the market in 1976 when the rules were changed. But the original legislation and a companion law enacted in 1990 instructed the agency to write rules that would set firm deadlines for when all Class III devices would have to undergo rigorous testing before being approved.

The agency laid out a plan in 1995 to write those rules but never followed through, the accountability office found. The result is that most Class III devices are still approved with minimal testing.

Agency officials told the accountability office investigators that writing the new rules was still important.

“When asked for their time frame for doing so, however, the officials did not provide one,” the report stated.

Dr. Susan Alpert, the chief regulatory officer of Medtronic, the leading maker of heart devices, said that many of the Class III devices that currently receive less scrutiny before approval would, once the agency completed its overhaul, be reclassified as less risky Class II devices.

“So the impression that F.D.A. is approving new technologies with little review is erroneous,” Dr. Alpert said.

Still, she said, “there is no question” that F.D.A. needs to fix its reclassification process.


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