FDA Gets Its Funding – But Without Any Patient Safety

If you blinked you may have missed this news item but it’s important to understand how government inaction hurts its citizens and this is a prime example.

On Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds the U.S. Food and Drug Administration’s oversight of medical devices for the next five years.

The device makers actually fund about 20 to 30 percent of the FDA’s budget to hire the scientific researchers who review medical devices for safety before they are approved.

Industry has been pressuring Congress to get MDUFA reauthorized as soon as possible.

Even though the budget is about $595 million in medical device user fees, almost doubling the budget from the last five years, industry wants something in return. The medical device makers, through their lobbying organizations, will require the FDA to adhere to tighter approval times and less stringent rules for approval. The money sounds good until you consider that industry wants to increase the actual number of medical devices that make it to the market, so tripling the work of the FDA is not compensated by a doubling of its budget.

Seeing the writing on the wall, Rep. Edward Markey (D-MA) introduced the Sound Devices Act. H.R. 3847, proposed to close a major loophole in the device approval by giving the FDA the authority to stop the approval of a medical device that names as its “substantial equivalent,” an earlier devices that’s been found defective or has been recalled.

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Naming a substantial equivalent is the way thousands of medical devices make it to U.S. consumers every year. No science required, just a predicate device selected and named.

Would the auto industry have used the Ford Pinto as a model car upon which to design a generation of cars to follow?  Of course not, but that is exactly what happened with synthetic surgical mesh. The ProteGen mesh made by Boston Scientific was recalled in 1999 after it was found to be defective. Regardless, because a generation of meshes used in women to treat pelvic organ prolapse and incontinence named as a predicate the ProteGen mesh.

And the FDA has no authority to stop it.

Rep. Markey expressed his disappointment when the Sound Devices Act was rejected by his fellow lawmakers in their markup of MDUFA. Without giving the FDA the ability to reject devices that are modeled after defective devices, the safety of untested devices will continue to be a question that is only answered by the ultimate clinical trial – using U.S. consumers as the guinea pig.

Patients have suffered irreparable and avoidable harm from metal-on-metal hips (approved based on a predicate), as well as synthetic surgical mesh, and defective defibrillator leads among the 3,000 medical devices fast-tracked onto the marketplace with no assurances required of the manufacturers for patient safety.

It was a safety loophole that Rep. Markey tried to close.

Instead, the MDUFA contains no mention of patient safety but plenty about the growth of jobs in the industry and bringing medical devices to the marketplace quicker. That does not square with what the American people say they want.

Consumers Union found in its recent poll that 82 percent of respondents believe preventing harm to consumers is a more important role for the FDA than encouraging innovation by limiting safety testing on devices.

Unfortunately, now the FDA is legally obligated to clear a new medical device if it’s similar to an earlier model, even if that model was recalled for serious safety problems. The industry exerts its control and the FDA limps ahead with its hands tied.

The MDUFA and PDUFA (prescription drug funding) approvals are part of the Food and Drug Administration Reform Act H.R. 5651 which now moves onto the full House and Senate for approval and on to the president for his signature likely to happen before the summer recess.