Further Problems Reported with FDA Medical Device Approvals

F.D.A. Criticized on Device Approvals
By GARDINER HARRIS
Published: January 15, 2009
WASHINGTON — Nearly two decades after Congress mandated that all high-tech medical devices undergo thorough reviews before being sold, the Food and Drug Administration still approves most such devices after minimal testing and perfunctory reviews.

In F.D.A. Files, Claims of Rush to Approve Devices (January 13, 2009) In a report released Thursday, the Government Accountability Office recommended that the F.D.A. fulfill promises it made 14 years ago to fix its system for approving complex medical devices. The report, mandated by Congress in legislation passed in 2007 to reform the F.D.A., comes in the midst of a near-rebellion among nine scientific reviewers within the agency’s device division.

Like the accountability investigators, the nine scientists have insisted that complex and potentially risky medical devices should be thoroughly tested before they are approved for widespread use. The scientists have written letters to both Congress and President-elect Barack Obama seeking significant changes at the F.D.A., and investigations into their claims are ongoing both at the F.D.A. and on Capitol Hill.

Most medical devices are given quick approvals with minimal testing because manufacturers tell the F.D.A. that the products operate just like older, already-approved devices.

“So on the one hand, the manufacturer wheels in their new Ferrari to the F.D.A. and says, ‘Look, it’s a car just like the Model T,’ ” said Dr. Peter B. Bach, a pulmonary physician at Memorial Sloan-Kettering Cancer Center and a former senior adviser to Medicare and Medicaid. “Then they go out in the marketplace and say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without any necessary actual improvement in outcomes.”

Created in 1976. the F.D.A. process for approving devices divides the products in to three classes and three different levels of scrutiny. Tongue depressors, reading glasses, forceps and similar products are called class I devices and are largely exempt from agency reviews. Hearing aids and mercury thermometers are class II devices, and most get quick reviews.

Class III devices include pace makers and replacement heart valves. Congress initially allowed many of the Class III risky 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 passed 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 and then never followed through, the accountability office found. The result is that most Class III devices are still approved with minimal testing. F.D.A. officials told investigators for the accountability office that writing the new rules was still important.

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

The accountability office recommended that the F.D.A. “expeditiously take steps” to change this situation.

As Reported in The New York Times 1/15/09