Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Just when we’d all decided Washington lawmakers couldn’t do much more than enjoy 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 its got 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% 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 health care 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 a myriad of potential changes, the Act would clarify the standardization of eligibility information in clinicaltrials.gov, and spur the Department of Health and Human Services to forge ahead with additional public/private partnerships with grants to promote patient advocacy groups and research of disease causes, especially for rare diseases.

SixGroupsAccording 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 FDA with more discretion in the development of the program.”

There’s still a lot to dissect from the Act, and, while passage appears likely, some provisions could still be tweaked or cut entirely. But one this is clear: Congress is probably going to shock a lot of us by actually pulling together a relatively bi-partisan 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.

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Congress Crawls Out of 20th Century to Push Bi-partisan 'Cures' Legislation
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Congress Crawls Out of 20th Century to Push Bi-partisan 'Cures' Legislation
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Just when we’d all decided Washington lawmakers couldn’t do much more than enjoy 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.
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