House nears vote on 21st Century Cures bill

Dive Brief:

  • The House is expected to vote Nov. 30 on a $6.3 billion legislative package that aims to accelerate the development of new cures and treatments. The bill would give states $1 billion in grants to address opioid addiction, while also boosting funding to Food and Drug Administration and the National Institutes of Health.

  • House and Senate legislators spent the weekend trying to pull together final details of the long-stalled bipartisan bill, called the 21st Century Cures Act. 

  • Among its numerous provisions, the legislation aims to push the FDA to speed approval of new therapies, and to improve patients' access to mental-health treatment.

Dive Insight:

The heavily lobbied bill — in the works for three years — has gained support from drug manufacturers, medical device makers and others. But some patient advocacy groups and researchers worry that a speedier FDA approval process for certain drugs and devices could endanger patients. 

Similar to the Affordable Care Act in 2009, the 21st Century Cures Act has sparked intense lobbying. The Pharmaceutical Researchers and Manufacturers of America, which alone has spent $24.7 million in lobbying for the bill, is among more than 1,400 lobbyists arguing its pros and cons in this congressional cycle, reports Kaiser Health News. 

Yet some consumer advocates worry about closed-door negotiations. Diana Zuckerman, president of the National Center for Health Research, told The Wall Street Journal that the bill “reads like a wish list for pharmaceutical and device companies,” and needs careful vetting and public scrutiny.

Senate Majority Leader Mitch McConnell, R-KY, sees passage of 21st Century Cures as a priority. He said he will push for a vote before the end of December, and Barack Obama is seen as likely to sign it into law.

Rep. Fred Upton, R-MI, chair of the House Energy & Commerce Committee who helped to spearhead the legislation, is also urging its swift passage in a lame-duck Congress as the best way to ensure funding occurs in fiscal 2017.

The bill would boost NIH funding, including $1.4 billion for the Obama administration's Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden’s "Cancer Moonshot,” and $1.6 billion for the BRAIN initiative to improve understanding of diseases like Alzheimer's and accelerate diagnosis and treatment, according to a statement from the House committee. 

Filed Under: Drug Discovery Clinical Trials Regulatory / Compliance Legal
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