More on Policy and Legislation

House passes 21st Century Cures Act by landslide, expected to pass Senate next week

Bill would bring new medicines to market, authorize billions in new funding for Precision Medicine, Cancer Moonshot, BRAIN initiatives.

Jeff Lagasse, Associate Editor

The U.S. House of Representatives this week passed the 21st Century Cures Act, 392 to 26, in bipartisan support of a bill that would speed new medicines to market and authorize an additional $4.8 billion in spending for medical research.

That extra funding will primarily be split between three research programs: the Precision Medicine Initiative, the BRAIN initiative, and Vice President Joe Biden's cancer moonshot, all of which were backed by the Obama administration.

The bill would also dole out about $1 billion to states to fight the ongoing opioid crisis. An additional $500 million would go to the U.S. Food and Drug Administration.

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The bill has drawn praise as well as criticism. Proponents have touted provisions that will fund mental healthcare programs, and lauded the effort to tackle cancer and the opioid epidemic; detractors worried it would weaken regulations on medical devices and allow the approval of drugs despite a lack of evidence regarding safety.

[Also: 21st Century Cures bill marked by historic amount of healthcare lobbying]

Originally passed by the House last year, the new version of the bill is a compromise, partly funding the research by selling some of the Strategic Petroleum Reserve and siphoning off funds from the Affordable Care Act's prevention programs.

Congressman Michael C. Burgess, MD, R-Texas, Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, said in a statement that the bill "has been a long time coming" and makes "government an ally, rather than an obstacle, in the cycle of medical innovation."

America's Essential Hospitals, meanwhile, said the bill "moves us closer to ensuring hospitals keep the resources they need to help their patients overcome homelessness, hunger, and other obstacles to good health."

Marc Scheineson, partner and leader of Alston and Bird's Food and Drug Law Practice, said it "will move U.S. life sciences into the modern age, allowing the U.S. to better compete with reforms already made by our foreign competitors. It modernizes and improves the U.S. regulatory framework while preserving full FDA regulatory authority and the safety and efficacy of U.S.-marketed products."

[Also: House to vote Wednesday on Cures Act]

Earlier versions of the bill would have made it easier for drug companies to obscure their financial contributions to hospitals and doctors under the Physician Payments Sunshine Act, a part of the ACA, but that was stricken from the version of the bill passed this week.

The bill heads to the Senate for a vote early next week, where lawmakers expect it will pass.

Twitter: @JELagasse