Hatch, FDA officials address MDMA

Washington, D.C. -- A bevy of medical device execs gathered in the nation's capital last week for the annual meeting of the Medical Device Manufacturers Association to hear hot topics affecting the industry. And among those in attendance was Sen. Orrin Hatch (R-UT), who took the FDA to task for its device clearance process, which he called fraught with uncertainty.

The medical device clearance process is unnecessarily lengthy, said Hatch, and this could prove problematic for the U.S., which could see an increasing number of jobs leave the country--as well as patients seeking the medical care they need elsewhere. He also took the FDA to task for its suggestion that the EMA was allowing unsafe products on the market; the agency had no proof to make such an assertion, Hatch maintained. Earlier this year, CDRH head Jeffrey Shuren criticized the faster European review system before Congress, suggesting that if the U.S. adopted it, there would be congressional hearings featuring testimony from patients who got hurt."There is significant under-reporting of safety problems in some European countries, and it takes longer to identify safety problems in Europe," he said at the time.

But Hatch's remarks could have some resonance with industry. Recently, results from a Northwestern University survey indicated that roughly two-thirds of small medical device and diagnostic companies are obtaining clearance for new products in Europe first, delaying the availability of those products in the U.S.

Furthermore, the FDA is becoming more risk-averse, and he is concerned about how the agency might implement certain aspects of 510(k) reform without needed congressional approval.

Hatch also urged industry to work together to defeat the medical device excise tax, which he says has been forced on industry in an "aggressive and hostile way," adding that attendees should "talk to your Democratic senators and House members" about how unfair the tax is.

FDA head Margaret Hamburg followed with her remarks, greeting Hatch as he exited the room. She thanked him for an "interesting start" and proceeded to assure the audience that the agency and Congress were working well together. Hamburg emphasized that the U.S. medical device industry was performing well despite the global economic downturn. However, she also cautioned against complacency. For example, venture capital funding for small- to medium-sized device companies has been constrained. Typically, funding doesn't come until later in the development cycle. This is clearly "not a good situation," she said.

She also pointed out that it is difficult to compare the FDA's device approval system with the one Europe has adopted. The European system lacks the requirement that a device be proven effective, and she has great concerns about adopting the EU approval model.

CDRH Director Jeffrey Shuren also made an appearance at the event to discuss what the agency is doing to help industry. He urged companies that have a problem to tell him or one of his representatives about it. He provided the example of NuVasive, which had a very productive meeting after coming in to speak about a specific problem.

Shuren also spoke about some of the problems facing CDRH, including turnover. Roughly 47 percent of reviewers in the center have four years or less of experience--but the workload has increased 26 percent since 2007, he said. And managers are lured away to other FDA centers, where they receive more pay. - Liz Hollis (email | twitter)