FDA “Scales Back Enforcement” of Quality Controls on Medical Devices

The Project on Government Oversight, an independent watchdog group that exposes problems in government, has learned that the Food and Drug Administration (FDA) has quietly reduced their enforcement of federal quality regulations at laboratories that develop medical devices. The FDA’s inspections of “good laboratory practices” dropped dramatically in the past few years: from 33 in 2005, to seven in 2007, to one in 2008, with no inspections at all planned for 2009.
The testing of medical devices, which range from stents to pacemakers to complex imaging machines, is overseen by a division of the FDA called the Center for Devices and Radiological Health. Shockingly, the division’s own scientists have revealed that managers squelched debate, which in turn led to the approval of devices that were of questionable effectiveness and were perhaps not entirely safe.
The Society of Quality Assurance, a group representing scientific researchers, said in a letter to Congress that FDA’s decision to reduce inspections and enforcement “may result in an irreversible cascade of adverse consequences to the protection of the public.”
Concern over faulty medical devices was heightened this January when a federal judge dismissed hundreds of lawsuits against Medtronic, the maker of a faulty cardiac device—a slender electrical cable that connects an implanted defibrillator to a patient’s heart. The judge made the ruling based on last year’s Supreme Court decision that bars lawsuits against medical device manufacturers if the FDA has approved their sale.
Many see this as an intolerable “Catch-22”: The FDA has scaled back enforcement and inspections of medical devices, which may allow more faulty products to be approved; then, because the FDA has approved them for sale, all lawsuits over death or injury from the faulty devices are prohibited. As one Georgetown University law professor puts it, “Consumers face the worse of all possible worlds. The FDA has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can’t sue companies for redress.”
Reps. Henry Waxman (D-CA) and Frank Pallone, Jr. (D-NJ) plan to reintroduce legislation that would nullify the Supreme Court decision. A similar bill in the Senate, sponsored by Ted Kennedy (D-MA) and Patrick Leahy (D-VT), is expected to be introduced in the coming months. Waxman and Kennedy’s solution to the problem is just to open the floodgates for more litigation, which already is a major factor driving up medical costs. Of course, the trial lawyers are major donors to Democrats especially. But perhaps Waxman and Kennedy, in addition to allowing lawsuits, could also address the underlying problem, which is at the FDA. Too bad it isn’t possible to sue the FDA for damages—that would get action! For now, if you have not already signed our petition at ReformFDA.org, please do so today.