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Michael Causey

FDA Compliance

Congress Crawls Out of 20th Century to Push Bipartisan ‘Cures’ Legislation

The 21st Century Cures Act improves the regulatory process

Published: Tuesday, June 9, 2015 - 11:41

Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big after all.

It’s called the 21st Century Cures Act, and it’s getting a lot of device and drug makers excited. It’s been under development since April 2014. Amazingly, the version Congress released recently is almost 50-percent shorter than the earlier draft. In a city full of bureaucrats who write memos about memos, that’s a pretty incredible feat.

Fresh off a May 15 Congressional vote moving the law closer to passage, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), praised subcommittee chairman Joe Pitts and ranking member Gene Green for their bipartisan work “recognizing the importance of medical technology innovation in answering the pressing challenges facing America’s healthcare ecosystem.”

Joining AdvaMed, among others, Leahy applauded legislation he says “provides substantive proposals to improve the regulatory process, while addressing ongoing challenges in obtaining adequate reimbursement for the cures and treatments that patients need.”

Among myriad potential changes, the 21st Century Cures Act would clarify the standardization of eligibility information currently found in clinicaltrials.gov, and spur the Dept. of Health and Human Services to forge ahead with additional public/private partnerships using grants to promote patient advocacy groups and research disease causes, especially rare diseases.

According to the folks at Hyman, Phelps, and McNamara, the new version is broader in terms of qualification of drug development tools. For example, “it now addresses biomarkers, surrogate endpoints, and other drug development tools; the first discussion draft focused primarily on surrogate endpoints,” reports the firm’s Law Blog. “On the other hand, it is narrower because it does not affect devices. The section also removes many of the formal procedures and timelines from the first discussion draft and provides the FDA with more discretion in the development of the program.”

There’s still a lot to dissect from the act, and although passage appears likely, some provisions could still be tweaked or cut entirely. But one thing is clear: Congress is probably going to shock a lot of us by actually pulling together a relatively bipartisan piece of legislation and placing it on President Obama’s desk before the end of the year.

Who’d have thought, right? Now, maybe these distinguished men and women can take a hard look at our nation’s infrastructure, tax code, and maybe a few dozen other issues that would also benefit from some good, old-fashioned bipartisan discourse.


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.