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21st Century Cures Act must also protect patients from harm

Usually not much is accomplished during a lame-duck session of Congress, but a major piece of health care legislation is on deck this week.

The 21st Century Cures Act is a sweeping bill that would boost National Institutes of Health funding for translational research, and speed up the Food and Drug Administration's ability to approve life-saving drugs and medical devices, among many other things.

But the deadly trouble with this bill is that it adds regulatory laxity to a medical device approval process which already suffers for need of more adequate safety regulations.

You can read all 1,000 pages of this bill here – including the medical device provisions aimed at accelerating approval, under the guise of innovation and efficient marketing of life-saving devices, starting on page 233. This bill is sausage laced with poison.

Among the  voices sounding an alarm on this safety deficit is U.S. Rep. Mike Fitzpatrick (R-PA), who has worked closely with us and other advocates on this problem.

In July 2015, when the House was considering the 21st Century Cures Act, Fitzpatrick called for amendments that would address the problem. But his colleagues, including a prominent ex-physician turned congressman, effectively killed these amendments.

Still, Fitzpatrick  voted "Nay" on the Cures Act in 2015, and then gathered a bipartisan coalition to attack the problem.

First, the "Fitzpatrick 12" triggered an investigation by the Government Accountability Office into the FDA process, which had allowed a dangerous medical device to harm women, undetected by FDA for nearly 20 years. This report is due from the GAO any day now.

Second,  Fitzpatrick rallied the support of a colleague from across the aisle to propose the Medical Device Guardians Act (H.R. 5404), which requires "self-reporting" of design flaws and complications associated with their use. Though this is a mandate of the American Medical Association's Code of Medical Ethics, it is not required by law.  The legislation has been collecting dust on the House docket since last June.

Now a massive lobbying effort is underway to make 21st Century Cures one of the 114th Congress' final acts, regardless of the threat posed by  its liberal medical device provisions.

Likely this week, the 21st Century Cures Act is poised to go back through the House of Representatives on its way to the Senate. The House is likely to invoke a "suspension of the rules" a maneuver that's supposed to be for noncontroversial bills. If so, and if no one objects, it will go directly to the Senate for passage.

As advocates for patient safety, we call on  Fitzpatrick and his colleagues who grasp the danger of the Act's medical device provisions to raise those objections.

Securing the medical device regulatory space efficiently may be a tall order for a Congress in gridlock. But passage of the Medical Device Guardians Act, which enjoys the support of harmed patients and their advocates, not big money interests, will be an even taller one.

Still, our best hope lies with Fitzpatrick, who soon will be leaving Congress. He has clarity enough on this problem to rise once again and object to leaving unsuspecting Americans in harm's way. Fitzpatrick knows that Congress can add the provisions of H.R. 5404 into the 21st Century Cures Act –to provide FDA with the real-time public health data it needs to defend patients from unsafe medical devices.

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