FDA commissioner reaches out to small businesses

AP News
Posted: Jul 15, 2011 2:01 PM
FDA commissioner reaches out to small businesses

The head of the Food and Drug Administration pledged Friday to work more closely with small medical technology companies, which have spent the last year alleging that the agency is needlessly slowing approvals of new drugs and devices.

In a speech before Cleveland business owners, FDA Commissioner Margaret Hamburg announced plans to invite medical entrepreneurs to train agency scientists on how to work with small businesses. Under the "entrepreneurs-in-residence" program, small business executives would serve as ambassadors between the FDA and the small business community.

That program and several other initiatives appear designed to offer an olive branch to some of the agency's toughest critics, who have lobbied Capitol Hill that FDA's review process is slowing development of new therapies and forcing companies out of business.

"When I meet with small business owners, they often have quite a bit to say, and much of what they share about how they view FDA is not all that flattering. And that truly concerns me," Hamburg told attendees at the City Club of Cleveland.

Republicans in Congress have held multiple hearings this year to air concerns from medical device makers that the FDA's review process has become too slow and burdensome. They point to some device companies that are launching their products in Europe first, where the bar for approval is lower. One widely-circulated figure by industry lobbyists estimates that new devices reach the U.S. market two years after they launch in Europe on average.

Faced with criticism from the business community and Capitol Hill, the FDA is slowly rolling out a campaign focused on innovation, highlighting ways the agency can help accelerate development of new therapies. As part of that effort Hamburg said the agency will begin paying more attention to small medical technology companies, most of which have fewer than 50 employees.

"After speaking at length with a number of small business owners, I understand that many of them feel very vulnerable in the face of what can seem like an extremely intimidating process to those who are unfamiliar with it," Hamburg said. "I am committed to taking steps to help ease the burden for small companies trying to navigate the FDA review process."

Along with the entrepreneurs-in-residence program, the FDA will offer fellowships to business and science students interested in starting their own companies. The agency is also looking for ways to collaborate with the Small Business Administration.

Advocates for small medical technology companies commended Hamburg for reaching out to small businesses, but reiterated their concerns.

"While we welcome efforts to improve interactions between industry and FDA, the core concerns of small and mid-sized medical technology businesses are the shifting requirements from FDA during a product review that are driving U.S. innovations overseas to the detriment of patient care and our economy," said Mark Leahey, president of the Medical Device Manufacturers Association.