Mesh medical device after removal

Medical device makers want to get their products into the marketplace faster.

The U.S. Food and Drug Administration (FDA) needs more operating capital to review medical devices.

The two have formed an informal agreement that was leaked to Bloomberg on Wednesday, February 1 (here). Under the proposed plan, medical device makers would pay $595 million over the next five years, roughly double the budget of the last five years, and the FDA would provide more predictable and “transparent” medical device evaluations.

Congress still must give the pact the okay, but it represents a significant jump from the current finding of $295 million that is set to expire on September 30.

An FDA spokeswoman, Karen Riley, told Bloomberg the two sides are “close to an agreement” over the Medical Device Users Fee which would mean the agency could hire about 200 more scientist reviewers, reports AP.  The quid pro quo would mean the FDA would increase the number of meetings with industry in advance of an approval submission for a new device, presumably to smooth the transition to market.

AP reports (here) that this agreement resulted from “more than a year of closed-door meetings between industry and the FDA” which continued beyond the January 15 deadline imposed by the FDA. Background story here.

Industry complains that Europe has faster more predictable reviews, however the recent PIP breast implant scandal now rocking Europe, background here, as well as the defective synthetic mesh implants are examples of what can result with less regulation, not more.

Drugmakers pay the agency a review fee as well, about 60 percent of the cost of FDA reviews of new pharmaceuticals.

The FDA had said it needed more like $805 million while the industry offered half as recently as December.

Slow Device Reviews?

On average it took the FDA 73 days to in 2010 to review a 510(k) application which is an exchange of paperwork with the manufacturer naming a predicate device the new device is substantially similar to. The 510(k) is supposed to be used for low-to-moderate risk devices, however transvaginal mesh and metal-on-metal hip implants have both been brought to market under the 510(k) process.

The Institute of Medicine in a report issued August 2011, here, said the 510(k) process was ‘fatally flawed” and should be abolished in favor of a new tighter, regulatory system.

And Consumers Union (CU) has just launched its SafePatientProject.org to abolish the practice of using a predicate device as an entre into the marketplace, and establish patient registries requiring manufacturers to track the safety and efficacy of its devices after they are used on patients. CU says that 700 different medical devices are recalled every year since 2005 which are responsible 5,000 American deaths in 2009.

About 90 percent of the approximately 4,000 medical devices applications brought to the FDA for approval are ushered in under the 510(k) fast-track approval process. #