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House probes why medical devices take longer to hit U.S. market

By

Rep. Joe Pitts

The medical device industry’ s increased juice in Washington is starting to power the Beltway agenda, as Republican House leaders take note of differences between European regulatory bodies and those in the U.S. Can Congressional hearings be far behind?

Rep. Joe Pitts (R-Pa.), the newly installed chairman of the House Energy and Commerce Health Subcommittee, signaled his intention to probe recent buzz that the European regulatory pipeline moves faster than its equivalent at the Food & Drug Administration. Throwing in his two cents in an op-ed in the The Hill yesterday, Pitts said he’s so interested in the issue that he’s looking to use his new power to get some answers.

“This week, the House of Representatives issued direction to the various committees to investigate federal government rules affect on jobs and the economy,” he wrote. “The Energy and Commerce Health Subcommittee has oversight over the FDA and, as chairman, I want us to explore why Europe has gained such a significant advantage over American companies.”

Pitts’ call for further investigation is a sure sign that the medical device industry’s public relations campaign is getting traction with its intended audience — Republican lawmakers riding the mid-term election wave.

Med-tech has pushed hard, looking to draw attention to three recent studies by PricewaterhouseCoopers, Stanford University and the Boston Consulting Group which conclude that medical innovation in the U.S. is sagging from over-regulation.

If successful, the PR blitz could undermine the federal watchdog agency’s call for stricter 510(k) regulations and even put a wrinkle in the re-authorization of the Medical Device User Fee Act set for 2012. Getting Pitts to parrot some favorite talking points is one sign that the message is sticking.

“Unfortunately, the FDA has become risk-averse in recent years,” he wrote. “Approval times have crept up, nearly doubling the time required in some cases. This means that European patients are receiving access to devices two years before American patients. In some cases, devices approved in Europe have never been legal in the U.S.”

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