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World & Nation

Senate passes $6.3-billion medical research bill and sends to Obama

FDA
The U.S. Food and Drug Administration campus in Silver Spring, Md.
(Associated Press)

Sprawling legislation to increase federal support for medical research, mental healthcare and controlling the opioid epidemic cleared the Senate easily Wednesday and is headed to President Obama’s desk for his signature, delivering a rare bipartisan breakthrough in the waning days of his presidency.

The $6.3-billion bill — known as the 21st Century Cures Act — won large majorities in the House and Senate despite warnings from some consumer groups that industry-sought provisions to speed approval of new drugs and medical devices jeopardize patient safety.

Obama, who strongly endorsed the bill, said it “could help unlock cures [for] Alzheimer’s, end cancer as we know it, and help people seeking treatment for opioid addiction finally get the help they need.”

The 94-4 Senate vote followed several years of lobbying by patient advocates and powerful industries, including drug manufacturers. The bill cleared the House last week by a 392-26 vote.

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“Finding solutions for deadly and debilitating health threats and combating insidious public health threats should be a dual imperative for our nation, and this legislation could well usher in an era of unprecedented progress on both fronts,” said Mary Woolley, president of Research!America, a coalition of more than 350 academic research organizations, disease advocacy groups, drug makers and other industries.

The bill would provide $4.8 billion to the National Institutes of Health to support research efforts, such as the so-called Cancer Moonshot initiative championed by Vice President Joe Biden.

Food and Drug Administration will receive an additional $500 million to streamline its review of new drug therapies.

The legislation also advances federal initiatives that have languished for years, including new funding sought by public health departments to combat the opioid epidemic.

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Other parts of the bill would support steps designed to strengthen the nation’s mental health system by coordinating treatment research, supporting community efforts to reduce homelessness and keeping mentally ill patients out of the criminal justice system.

Advocates say substantial additional funding is needed beyond what is provided in the bill.

The legislation has generated concerns among many consumer advocates, who have warned that provisions that would speed federal regulatory review of new drugs and medical devices could expose patients to new risks.

“The bill has been sold erroneously as a common sense, bipartisan compromise that enables scientific innovation and medical breakthroughs for America,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “But in reality, 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.”

Several leading liberal lawmakers have also blasted the legislation for including what Sen. Bernie Sanders (I-Vt.) last week called “corporate giveaways that will make drug companies even richer.”

The White House acknowledged that it has issues with parts of the legislation, but Obama noted that the trade-offs were worth it.

“Like all good legislation, it reflects compromise,” the president said during his weekly radio address Saturday.  

Hospitals and insurance companies successfully lobbied for the bill to include provisions shielding them from cuts in what the federal Medicare program pays them.

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Another provision favored by industry would exempt some payments that physicians receive from drug and device makers from federal reporting requirements designed to alert patients to potential conflicts of interest.

Conservative activist group Heritage Action for America opposed the bill because it will add to federal spending.

The bill’s spending is offset with cuts in Medicare payments for drug therapies and medical equipment, other spending reductions and the sale of 25 million barrels of oil from the nation’s strategic petroleum reserve.

Twitter: @noamlevey

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