House Passes Bill to Speed Up Drug Approvals

By | December 1, 2016

The U.S. House of Representatives on Wednesday passed a sweeping, $6.3 billion bill that supporters say will spur medical innovation, speed access to new drugs, expand access to mental health treatment and battle the opioid epidemic.

The 21st Century Cures Act had widespread bipartisan support, including the backing of the Obama administration, although critics have said it gives massive handouts to the pharmaceutical industry while making cuts to public health programs and the Medicare health insurance program for seniors.

Two years in the making, the legislation contains 19 core bills, including measures to advance personalized medicine, shorten drug approval review times and boost Alzheimer’s and cancer research. The House passed the bill by a vote of 392-26. The Senate is expected to vote on it next week.

The White House said in a statement after the House vote: “The Senate should promptly pass this bill so that the President can sign it.”

The bill, sponsored by Republican Representative Fred Upton of Michigan, authorizes $4.8 billion to the National Institutes of Health and $500 million to the Food and Drug Administration to streamline the clinical trial process and hire new staff.

It also envisions $1 billion over two years to battle opioid and heroin abuse and $1.8 billion to support Vice President Joe Biden’s Cancer Moonshot initiative, designed to speed research into new cancer therapies.

Critics of the legislation, including Democratic Senators Elizabeth Warren of Massachusetts and Jeff Merkley of Oregon, and Democratic Representative James McDermott of Washington, have said the funds may not ultimately be forthcoming as they must be appropriated by separate funding bills.

In the meantime, changes to the FDA’s regulatory authority would be law. Those changes, critics said, would lower standards for drug approvals and jeopardize patient safety.

“We put the FDA in the position of protecting the American public and then we cut them out at the knees,” McDermott said before the vote, adding the bill would open the door for companies “to push out any drug they want.”


Money to pay for the bill would be offset by reductions in other spending, including Medicaid payments for some medical equipment and through the sale of oil from the Strategic Petroleum Reserve, something the administration said “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”

House Speaker Paul Ryan said the measure “is going to be a game-changer,” adding: “It will fundamentally transform the way that we treat and cure diseases in this country.”

A provision that would have made it easier for companies to conceal payments to doctors under the guise of continuing education was dropped at the last minute. Republican Senator Charles Grassley of Iowa had opposed the provision.

“This is good news for transparency and the public,” Grassley said in a statement on Tuesday. “With drug prices through the roof, the way drug and device makers spend money is of more public interest than ever.”

Patient advocates support the bill, which requires that their voices be brought more formally into the drug approval process. Patients have increasingly put pressure on the FDA to approve drugs even if evidence that they work is slim.

The bill expands access to mental health treatment and services. Vern Buchanan, Republican representative from Florida, called the provision “a breath of fresh air after decades of flawed policies.”

(Reporting by Toni Clarke; Additional reporting by Richard Cowan; Editing by Tom Brown and Peter Cooney)

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