Device CEOs Fear New FDA Resources Will End Up On Food’s Plate

Full article reprinted from "The Gray Sheet" - June 1, 2009 

With congressional scrutiny of food safety at an all-time high, medical device executives are worried that FDA's newfound resources will be diverted from devices toward the food sector. Find out more...

Device CEOs Fear New FDA Resources Will End Up On Food’s Plate

Full article reprinted from "The Gray Sheet" - June 1, 2009 

With congressional scrutiny of food safety at an all-time high, medical device executives are worried that FDA's newfound resources will be diverted from devices toward the food sector.

Lawmakers have acknowledged that FDA needs more resources to fulfill its complex duties regarding food and medical product safety. The agency received a major funding boost in 2008, a 19% increase in 2009, and could potentially see a 15% gain in the coming fiscal year ("The Gray Sheet" May 11, 2009, p. 3).

The new funds are encouraging, says Edwards Lifesciences CEO Michael Mussallem, but "we're not confident that that ends up in the medical device side of FDA."

Recent public discourse by the FDA leadership team reinforces the point.

Food safety dominated a May 21 dialogue between FDA Deputy Commissioner Joshua Sharfstein and several members of Congress ("The Gray Sheet" May 25, 2009, p. 6). And medical devices are barely mentioned, while a number of specific food and drug issues get play, in a recent New England Journal of Medicine editorial penned by newly sworn-in FDA Commissioner Margaret Hamburg and Sharfstein.

"There's probably a lot of [the funding] that ends up in the food side," Mussallem, chair of AdvaMed's board of directors, said May 25 at an international device conference in Rome co-sponsored by AdvaMed and several international trade associations.

"We have to be realistic," agreed James Mazzo, AdvaMed board member and president of Abbott Medical Optics, at the May 25-27 meeting. Food safety is "the highlight on the President's agenda."

A large portion of FDA's budget will also probably go toward additional foreign inspections of food, drug and device manufacturers, and toward opening additional FDA offices abroad, B. Braun Medical chief executive Caroll Neubauer predicted.

Industry supports more resources for CDRH, in part as a means to achieve and maintain an efficient pre-market review process.

"One of our concerns is to make sure that the medical technology side, where there are continued increased burdens, is adequately funded," Mussallem stressed during the meeting. "That's a constant challenge."

The President's budget proposal for FY 2010 does set targets for how much funding would be set aside for FDA's various centers. Under the proposal, CDRH would see a 19% increase from last year to $371 million, including user fees.

However, Mussallem questioned how rigorously those spending targets would be enforced.

"We sure are worried," he told "The Gray Sheet," though he noted that Congress remains fairly concerned about device safety, as well.

FDA does have some flexibility in how it actually ends up spending its Congressional appropriations. However, user fees paid to FDA in the fiscal budget cannot be diverted from device center activities.

About 15% of the 2010 budget for CDRH is user-fee funded ($56 million).

"CDRH has done quite well in the last few years," AdvaMed CEO Steve Ubl emphasized.

Food Safety Could Become Our Problem - CEO

The Edwards CEO also suggested that widespread criticism of FDA over outbreaks of food-borne illness - salmonella in peanuts and pistachios, for instance - will result in an increasingly cautious agency.

That criticism "puts a tremendous amount of pressure on the FDA and, in general, probably causes them to be even more cautious and conservative than they might have been before," Mussallem said. "Does that wash over? Yeah, I'd say general scrutiny of the FDA is probably pressing them to be more conservative in their interpretation."

- Jessica Bylander  

Companies included in this article: Abbott Medical Optics, B. Braun Medical, and Edwards Lifesciences

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