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Michael Causey

FDA Compliance

Lawmakers’ Silly Season No Laughing Matter for Device Industry

Medical device firms are always one recall away from increased scrutiny

Published: Wednesday, March 28, 2012 - 10:29

Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012, and that will only increase if President Obama is reelected in November.

The climate is not great for medical device firms, which are always one recall away from increased scrutiny. Add to that a recent poll from Consumer Reports that says the public wants more medical device regulation and less risk.

The poll was released just as House and Senate committees have issued draft legislation to reauthorize the statute governing medical devices, and at a time when the FDA’s process for reviewing new implants has come under intense criticism.

The House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight and should be rejected by Congress, according to Consumers Union, the policy and advocacy arm of Consumer Reports. Although the Senate Health, Education, Labor, and Pensions Committee’s draft bill provides some additional protections for patients once devices are on the market, it misses the opportunity to enact a clear process for preventing unsafe devices from being sold in the first place, the consumer group claims.

“Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective,” says Lisa Swirsky, senior policy analyst for Consumers Union. “Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements, but it should be strengthened to require stricter safety testing of new implants and life-sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available.”

Consumers Union says the medical device industry has been pushing Congress to scale back oversight of implants and other devices, which it claims is necessary to promote innovation and make it easier to get new devices approved. But according to the new Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

In his FDA Matters blog, Steven Grossman advises us not to take our eyes off the User Fee Authorization Process in 2012, which must be renewed by Sept 30, 2012.

Grossman sees three levels to watch: “the MDUFA reauthorization itself, including FDA-industry agreement on goals for the review process; a core of changes to the medical-device review process that has consensus support but not necessarily agreed-upon legislative language; and a group of more far-reaching changes to the medical device review process that are considered controversial.”

And, “There will be continued efforts to roll back or repeal the device tax imposed by the health reform act,” he also tells us.

I’ll have more to say on this subject as the silly season gears up.

This article first appeared in the March 26, 2012, edition of the AssurX Blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.