U.S. House passes 21st Century Cures Act; Senate OK seen likely

The U.S. Senate is likely to approve the $6.3 billion 21st Century Cures Act next week after their counterparts in the U.S. House voted 392-26 yesterday to enact the sweeping healthcare legislation.

Supporters say the bill will spur medical innovation, speed access to new devices and drugs, expand access to mental health treatment and battle the opioid epidemic. Although the bill has widespread bipartisan support, including from the White House, critics say it gives massive handouts to the medical device and pharmaceutical industries and cuts public health programs and Medicare.

The measure, which has been bouncing around Capitol Hill for 2 years, consists of 19 core bills, including provisions to advance personalized medicine, shorten device and drug review times at the FDA and boost Alzheimer’s and cancer research.

“The Senate should promptly pass this bill so that the president can sign it,” the administration said in a statement after yesterday’s vote.

“As with any piece of legislation that is passed by a Republican Congress and signed into law by a Democratic president, it’s going to require some compromise,” added White House press secretary Josh Earnest, according to the Wall Street Journal. “There are some elements of the bill that the administration doesn’t support. I’m confident that there are some parts of the bill that some Republicans don’t support either. But at the end of day, I think the bill will get overall support from Democrats and Republicans.”

Sponsored by Rep. Fred Upton (R-Mich.), the 21st Century Cures Act would give the FDA $500 million to streamline the clinical trial process and hire new staff. The act would also fund the National Institutes of Health to the tune of $4.8 billion over 10 years. It would put $1 billion over 2 years toward battling opioid and heroin abuse and $1.8 billion toward Vice President Joe Biden’s Cancer Moonshot.

Critics of the legislation, including Sens. Elizabeth Warren (D-Mass.) and Jeff Merkley (D-Ore.) and Rep. James McDermott (D-Wash.), have said those funds are subject to separate appropriation bills and might not materialize. But the act’s changes to the FDA’s regulatory authority would be law; critics say those provisions would lower approval standards 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 told the House, adding the bill would open the door for companies “to push out any drug they want.”

“The money is subject to appropriations,” McDermott told his colleagues, according to Xconomy. “Everybody says, ‘Oh, well, there’s commitments made.’ Anybody who believes in the tooth fairy will believe that money is going to go to the NIH.”

Sen. Dick Durbin (D-Ill.) told the Senate yesterday that he is “totally underwhelmed by the amount of money in this bill” for the NIH, according to the Journal, and lamented that some $3.5 billion of the bill’s funding would come from a public health and disease-prevention portion of the Affordable Care Act.

‘Game-changer’

The bill’s cost 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 Obama 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 (R-Wis.) 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 at the behest of Sen. Charles Grassley (R-Iowa), 1 of the architects of the Physician Payment Sunshine Law.

“This is good news for transparency and the public,” Grassley said in prepared remarks this week. “With drug prices through the roof, the way drug and device makers spend money is of more public interest than ever.

“Watering down sunshine provisions is counterproductive and goes against the trend in health care to have more transparency, not less,” he said.

Material from Reuters was used in this report.

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