FDA aiming to speed OK of medical devices

“This is a complex world,’’ said Margaret Hamburg of FDA.
“This is a complex world,’’ said Margaret Hamburg of FDA.

CHICAGO – Under fire from the industry for being too slow to approve medical devices and diagnostics, Food and Drug Administration Commissioner Margaret A. Hamburg told a medical technology trade group Tuesday that her agency is working on ways to get new products to market faster.

FDA officials are streamlining reviews “to make sure really promising products can move through the system swiftly but with a robust regulatory process,” Hamburg told more than 1,500 executives at the annual conference of the Advanced Medical Technology Association, known as AdvaMed.

Among other steps, the agency has proposed an expedited approval process for devices aimed at treating life-threatening or irreversibly debilitating diseases or conditions for which there are no other products available, Hamburg said.


But she acknowledged the FDA has fewer programs to fast-track experimental medical equipment and diagnostics than it does for experimental drugs.

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“This is a work in progress,” Hamburg said. “We all know that change does not happen overnight. . . . We still have some challenges in being able to recruit and retain all the people we need” to review products.

Industry representatives said the FDA is working to address what they described as a more than three-year gap between when many medical products are approved in Europe and their launch in the United States. But with financing for early stage medical technology companies in decline, many have begun moving clinical trials out of the United States — or even starting companies abroad in more business-friendly locales.

“The horse has already left the barn,” warned Mark Deem, managing partner of the Foundry LLC, a medical device startup incubator in Menlo Park, Calif. “It’s gotten to the point where entrepreneurs are just moving all their early stage medical device activities lock, stock, and barrel overseas.”

While the number of new drugs approved has been on the rise, the number of medical devices entering the market under the FDA’s “pre-market approval” process tumbled from 41 in 2012 to 23 last year. The number approved under a separate process geared to improvements on products already on the market fell from 3,185 to 3,085 during that same period, according to market intelligence firm Evaluate MedTech.


Lisa McGiffert, manager of the Consumers Union Safe Patient Project in Austin, Texas, said it was important for the FDA to continue to balance the safety of patients against pressure to speed up approvals.

“From the consumer perspective, we have concern about how the [FDA] system is constructed,” McGiffert said. “We don’t have the infrastructure to do safety testing up front and [don’t] have a national monitoring system in the post-market setting.”

Hamburg said the FDA has begun initiatives to get more feedback from patients as well as entrepreneurs to help regulators better understand the risk-benefit trade-offs of new medical technology. “Clearly, this is a complex world,” she said. “Science and technology are advancing at a pace that would have been unthinkable only a few years ago.”

But she cautioned industry leaders not to hold up Europe as a regulatory model, noting safety concerns there have prompted a reassessment of review processes.

“It’s not really a race as to who’s first,” Hamburg said. “It’s to get great products to individuals.”


Earlier on Tuesday, executives at the AdvaMed conference were welcomed to Chicago by Mayor Rahm Emanuel, who suggested they spend as much money here as possible and consider setting up shop in the city’s emerging health care business hub.

“The medical technology industry in the Midwest is a juggernaut.” Emanuel said. “I want you to see Chicago in your future.”

Emanuel said Chicago is making a push to expand its medical technology sector, inviting venture capitalists from both coasts to an upcoming forum and opening a health care business incubator downtown in the city’s historic Merchandise Mart.

The mayor, a Democrat and former White House chief of staff, worked for passage of President Obama’s health care overhaul. It included an excise tax on medical gear that, for obvious reasons, is unpopular with many medical devices executives.

“I didn’t know if I should go into a witness protection program,” Emanuel joked before he spoke.

Also during the conference, US Representative Peter J. Roskam, an Illinois Republican and chief deputy whip in the House, called on executives to push for tax code changes that would eliminate the medical device tax and make it more competitive for companies to keep their corporate headquarters in the United States.

“No one can defend the status quo,” he said. “There’s a national consensus that our tax code has got to be reformed.”

Roskam praised the innovations created by medical technology companies, noting his father has a hearing aid and his mother has “knees and hips and all kinds of things that you people make, and she’s skipping around like a teenager.”

Robert Weisman can be reached at Follow him on Twitter @GlobeRobW.