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21st Century Cures Act Passes House, but Faces Senate Critics

The 21st Century Cures Act cleared a House vote with flying colors, but the precision medicine and medical innovation bill has not satisfied critics of its drug deregulation provisions.

By Jennifer Bresnick

- The 21st Century Cures Act passed a House vote by a wide margin Wednesday, and will head to the Senate for what may be a bit of a difficult fight to the President’s desk. 

21st century cures act for precision medicine passes the house

The bill, which provides the possibility of around $5 billion in funding for precision medicine and cancer research, also contains some more controversial provisions related to deregulation of the FDA’s drug approval process that have attracted protests from leading voices in the Senate.

“This critically important legislation will get states the resources they need to fight the heroin and prescription opioid epidemic,” the White House added in a press release lauding the 392-26 House approval of the bill.

“It invests the $1 billion the President has repeatedly said is necessary to help communities that have seen far too many overdoses. H.R. 34 also takes important steps to improve mental health, including provisions that build on the work of the President's Mental Health and Substance Use Disorder Parity Task Force.”

While the original bill offered billions in funding for the National Institutes of Health (NIH) and FDA with few strings attached, the newest version of the legislation would require Congress to vote each year to allocate $2.8 billion to NIH and $430 million to the FDA to support the Precision Medicine Initiative, BRAIN Initiative, and Vice President Biden’s Cancer Moonshot, leaving the future of these programs less than certain.

READ MORE: 21st Century Cures Act for Precision Medicine Set for House Vote

Some Senate opponents of the bill, including Democrats Elizabeth Warren (D-MA) and Bernie Sanders (I-VT), do not believe the potential for research funding outweighs the negative implications of FDA deregulation.

“For more than two years, Congress has been working on legislation to help advance medical innovation in the United States,” Warren said during a speech to the legislature before the House vote. “Medical innovation is powerfully important, and I have spent as much time working it as any other issue during my time in the Senate.”

“But…this final deal has only a tiny fig leaf of funding, for NIH and for the opioid crisis.  And most of that fig leaf isn’t even real,” she added, referencing the yearly vote requirement to secure the research funding.

“This funding is political cover for huge giveaways to giant drug companies.”

Warren’s dissatisfaction stems from provisions that would allow drug companies to sell medications for off-label uses, effectively bypassing the complex and length approvals and safety testing process.  The bill also allows some additional exclusions from the Sunshine Act, which requires physicians to publically disclose funds or gifts from pharmaceutical companies.

READ MORE: FDA to Streamline Regulations in Light of 21st Century Cures Act

Sanders also raised objections.  “At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices,” he said.  “This is a bad bill which should not be passed in its current form.”

But the wide-ranging bill, which also contains provisions adjusting Medicare payments, expanding health data interoperability, and improving the potential for telehealth coverage, has generally garnered enthusiasm and approval from lawmakers and many industry groups.

“The Association of American Medical Colleges (AAMC) is pleased that today the House passed the 21st Century Cures Act by a strong, bipartisan vote of 392-26, said President and CEO Darrell G. Kirch, MD in a statement emailed to journalists. “We are grateful the House has confirmed its commitment to medical research and other patient care issues vital to improving the health of all Americans. We urge the Senate to pass this critical legislation.”

Congressman Pat Tiberi (R-OH), who included several provisions related to Medicare and hospital reimbursements, also praised the House’s commitment to the bill.

“This bipartisan and bicameral bill is another example of how the House is delivering the patient-focused solutions Americans deserve,” he said.  “Let’s pass 21st Century Cures on a bipartisan basis and put America back in the driver’s seat on medical innovation while also providing needed relief, more choices and access for our nation’s seniors, small businesses, providers and families.”

READ MORE: Sen. Alexander Teases “Most Important” Precision Medicine Bill

Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), also applauded the deal.

“With today’s overwhelming bipartisan vote, we took a giant leap forward on the #Path2Cures,” they said.

“21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need. The White House has expressed its enthusiastic endorsement of this critical legislation. So it’s now on to the Senate, where we are just one final vote away from delivering #CuresNow.”

The legislation now heads to the Senate, which may vote on the package within the next two weeks. 

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