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Medical innovation bill sails through Congress

Legislation authorizes increases in funding for NIH, FDA with caveats

by Britt E. Erickson
December 8, 2016

Photograph shows buttons with the #cures logo
Credit: House of Representatives, Energy & Commerce Committee
Proponents of the 21╔st╔ Century Cures Act sported buttons around Capitol Hill this year to promote the bill.

In one of their last moves of the year, U.S. lawmakers in the House of Representatives and the Senate cleared legislation designed to boost medical innovation and stem the growing opioid abuse crisis. The 21st Century Cures Act (H.R. 34) now heads to President Obama, who is expected to sign the bill into law.

21st Century Cures by the numbers


$6.3 billion authorized, but no guarantees.

Where the funding would come from …

$3.5 billion from a special fund established under the Affordable Care Act to promote prevention of diseases

$1.4 billion from changes to Medicaid and Medicare

$1.0 billion from sales of the Strategic Petroleum Reserve

$464 million from rescission of funding for territories under the Affordable Care Act

… and where it would go:

National Institutes of Health: $4.8 billion over 10 years

$1.4 billion for a precision medicine initiative aimed at unraveling the genetic, lifestyle, and environmental variations of disease

$1.8 billion for cancer research

$1.6 billion to better understand diseases of the human brain such as Alzheimer’s

U.S. states: $1 billion over two years to deal with opioid addiction and mental health issues

Food & Drug Administration: $500 million over 10 years to modernize the U.S. drug and device approval process and to increase size of FDA staff

The bipartisan legislation authorizes $6.3 billion over 10 years to be funneled to the National Institutes of Health, the Food & Drug Administration, and states. But the money is not guaranteed. Congress would still need to approve the funding each year.

About $4.8 billion of the money is authorized for NIH to fund a cancer initiative, a genomics-based precision medicine effort, and research on the human brain. Another $1 billion would go to states to help deal with opioid addiction. The remaining funds are slated for FDA to accelerate the approval of new drugs and devices and to hire new scientists, doctors, and engineers.

Spearheaded by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), H.R. 34 aims to include patient experiences in the drug approval process and bring cures to patients faster. To do so, it reduces the amount of data pharmaceutical companies need to provide to FDA to support the approval of certain new drugs. For example, the legislation allows FDA to accelerate the approval of regenerative therapies, and in some cases use data summaries in lieu of full clinical trial data. It also allows drug companies to market their products “off label” for uses that have not been approved by FDA.

Opponents of the legislation are calling such provisions a huge giveaway to the pharmaceutical industry, which pushed hard for their inclusion. “The legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices,” says Michael Carome, Director of the Public Citizen’s Health Research Group, a consumer advocacy organization.

Sen. Elizabeth Warren (D-Mass.) and a few other Democrats in the Senate fought the bill, emphasizing that it does not include sufficient money for NIH for medical research. “Most of the money won’t really be there unless future Congresses pass future bills in future years to spend those dollars,” Warren says.

On the House floor, Rep. Rosa DeLauro (D-Conn.) also opposed the legislation. “It reduces the already weak regulations on medical devices, allows drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

The pharmaceutical industry is welcoming the passage of the bill, even though companies did not get everything they wanted, including a provision to give manufacturers longer market exclusivity for some drugs.

“The legislation includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development,” says Pharmaceutical Research and Manufacturers of America CEO Stephen J. Ubl. “It also increases FDA’s regulatory capabilities to foster the timely review and approval of new treatments for patients.”


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