House passes sweeping health innovation bill with $1 billion for opioids

WASHINGTON—The House approved a sweeping health policy bill on Wednesday aimed at sparking medical innovation, strengthening mental health services, and curbing the nation’s deadly opioid epidemic.

The measure, called the 21st Century Cures Act, would channel nearly $4.8 billion over the next decade to the National Institutes of Health for cutting-edge research on everything from Alzheimer’s disease to cancer to traumatic brain injury. It would also increase funding for the Food and Drug Administration, speed up approval for new drugs and medical devices, and provide $1 billion in new funding over the next two years for opioid addiction prevention and treatment programs.

"This is going to be a game-changer," House Speaker Paul Ryan, R-Wis., said at a news conference Wednesday. "It will fundamentally transform the way that we treat and cure diseases in this country."

The bill cleared the House with broad bipartisan support, 392-to-26, despite a pocket of opposition from hard-line conservatives who said it was a legislative goodie bag loaded with special-interest surprises. It will now go to the Senate, where supporters expect it to pass by next week despite opposition from some Democrats who say it's a giveaway to the drug industry.

"When American voters say Congress is owned by big companies, this bill is exactly what they are talking about,” said Sen. Elizabeth Warren, D-Mass., in a Senate floor speech Monday.

Proponents of the bill in both parties brushed off such criticism.

"We’re voting to put vital innovations in biomedical research within reach, potentially saving countless lives," said Diana DeGette, D-Colorado, who worked on key portions of the bill.

Rep. Fred Upton, R-Mich., chief sponsor of the bill and chairman of the House Energy and Commerce Committee, said the Cures legislation would ensure the U.S. health system kept pace with major advances in science and technology. "The clock is ticking for patients and their families," Upton said during an emotional pitch for passage.

In a statement released Tuesday night, the Obama administration also strongly endorsed the bill and noted that it includes a bevy of the president's priorities.

In addition to the boost to NIH funding, the legislation would:

* Devote $1.8 billion to support Vice President Joe Biden's "Cancer Moonshot" initiative, which aims to accelerate research into new cancer therapies and expand prevention and early detection;

*Modernize the FDA's drug approval process and help the agency recruit top scientists;

*Establish a mental health and substance abuse "policy laboratory" to promote better prevent and treatment of those diseases;

*Strengthen existing laws requiring insurers to cover mental health the same way they cover other medical issues.

Supporters hailed the mental health reforms as the most significant changes in decades.

“For far too long Americans suffering with mental illness have been stigmatized and left in the shadows,” said Rep. Vern Buchanan, R-Fla.. “This bill helps stop Americans from falling through the cracks."

On top of all the big-ticket items, the 996-page bill also includes a raft of smaller provisions dealing with electronic medical records, suicide prevention, and substance abuse. Critics said it had ballooned into a big-government spending bill and was being rushed through before lawmakers adjourn for the year.

"Backroom negotiators have turned the Cures bill into a Christmas Tree, loaded with handouts for special interests, all at the expense of the taxpayer,” Heritage Action for America, a conservative advocacy group, said in a statement urging the bill’s defeat.

One of the most controversial items in the measure would allow some regenerative medicine treatments, which use adult stem cells to repair damaged tissue and organs, to hit the market without clearing all the usual Food and Drug Administration hurdles.

Warren said these treatments could be marketed to “desperate people without a final FDA determination that those therapies are effective or safe.” She suggested the provision was a gift to GOP mega donor Ed Bosarge, a Texan who has invested in regenerative medicine. Bosarge has given nearly $1.5 million to GOP candidates and committees since 2012, according to campaign finance records, and one of his companies has spent more than $600,000 lobbying on the Cures bill over the last two years.

“Now he wants his reward,” Warren said. And the Cures bill “delivers a special deal so people can sell these treatments without meeting the FDA gold standards for protecting patient safety.”

Bosarge did not return a message seeking comment left at his Houston company. But others dismissed Warren’s complaints, saying the Cures bill will not undermine FDA standards or controls on experimental treatments.

Michael Werner, executive director of the Alliance for Regenerative Medicine, said FDA changes will put the U.S. on equal footing with other countries that have already recognized the transformative power of these new treatments.

The mental health provisions and opioid money won over many Democrats who had been clamoring for congressional action on those two issues. The opioid issue in particular has reached into every corner of the country, with nearly 80 Americans dying every day from opioid overdoses. Such deaths have quadrupled since 1999.

Addiction treatment advocates hailed the Cures bill as a potential turning point in the fight against this crisis.

“This legislation can help create real change for the millions of Americans impacted by the opioid crisis,” the Coalition to Stop Opioid Overdose said in a statement on the eve of House passage.

To cover the bill's $6.3 billion price tag, negotiators would tap the U.S. strategic petroleum reserve and raid a pot of money created under the 2010 Affordable Care Act for disease prevention.


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