Wanted: Common sense reforms at FDA

September 1, 2009 by Karin Gregory

We watch to see the outcome of the hearings and discussions from the Congressional activities that have stemmed from the U.S. Supreme Court’s February 2008 decision in Riegel v. Medtronic Inc. Congress is rushing to enact the Medical Device Safety Act of 2009 to reverse the preemption bar for those injured by medical devices that have been approved for use via the pre-market approval process of the Food & Drug Administration.

According to the bill's sponsors, Frank Pallone Jr. (D-NJ) and Henry Waxman (D-CA), the Court’s decision "left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages" ... and it left the incentive to maintain product safety and disclose latent defects to physicians and patients.

This activity is of concern to the industry on a variety of levels. First, most medical devices on the market today are not PMA devices, but are cleared for use by the FDA via the 510(k) pre-market clearance process. Those devices, about 5,000 per year, are on the market as a substantial equivalence standard. Of these, 2 percent to 5 percent may be required to submit clinical data or other confirmatory information as to their safety and efficacy beyond identifying a predicate device. There is no federal preemption for devices on the market through the 510(k) process. The Court acknowledged that the FDA's process was not as rigorous for those cleared devices as it is purported to be for the PMA approved devices.

Second, this type of rush to correct a wrong may make the men and women in Congress feel vindicated, but why not focus on the FDA process, the staffing at the FDA, the rulemaking at the FDA and the leadership at the FDA?

A General Accounting Office report (PDF) released earlier this year found that 228 medical devices were cleared as 510(k), even though they were Class III. That does not speak to more complex legislation, but to new FDA processes and clearer regulatory pathways for industry to follow.

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