A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH

Posted 31 October 2016 | By Zachary Brennan 

A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH

With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes.

Last month, Senate Majority Leader Mitch McConnell (R-KY) and House Speaker Paul Ryan (R-WI) put the bill on its lame duck priority list, with McConnell going so far as to call the bill, if passed, “the most significant piece of legislation we pass in the whole Congress.”

The massive bill was known first as the 21st Century Cures Act when it passed the House in July 2015, but then it transitioned in the Senate to a “biomedical innovation” bill with 19 different pieces of companion legislation, and most recently came to a standstill because of a disagreement over funding.

What it Would do

Among other changes, the Senate bill in its most recent iteration would amend FDA’s reviews of device trial data, exclude certain types of software from FDA’s purview, expand FDA's priority review voucher programs and add other new restrictions and requirements to FDA’s workload.

The House bill, meanwhile, includes several device “regulatory process improvements,” including expediting the review of breakthrough devices (which FDA has since developed policies on), and allowing devices to be approved based on registry data, studies from peer-reviewed journals and data collected in countries other than the US, as well as new provisions to speed the review of certain Class I and II devices.

What’s Happening Now

Most recently, the Center for American Progress, AFL-CIO, Public Citizen and others have called on House and Senate Democrats not to move the bill forward during the lame duck session unless it's reformed and deals with drug pricing issues, which industry lobbying group PhRMA said it would oppose. PhRMA has been lobbying on behalf of the bill's passage.

Despite the pushback from the groups on reforming the bill, House Democrats have said they are still working on an agreement and House minority leader Nancy Pelosi (D-CA) predicted earlier this month that the bill will pass in the lame duck session.

As far as the drug pricing demands, according to Politico, a watered-down version of the CREATES Act, which aims to stop anticompetitive practices brand companies often use to thwart or delay the entry of less-expensive generic versions, could be included in the final version of a new Cures bill.

Meanwhile, some researchers are calling for the bill’s passage, though a draft of its latest iteration has yet to be released. United for Medical Research and others on Friday called on House and Senate leadership to push the bill through, arguing in favor of a hike in NIH funding.

Categories: Regulatory News

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