In one of the most sweeping and rare bipartisan acts of this Congress, lawmakers will move this week on a $6.3 billion bill to increase funding for research into cancer and other diseases, address problems in the nation’s mental health systems and enact potentially far-reaching regulatory changes for drugs and medical devices.
House and Senate Republicans agreed over the weekend on a final version of the 21st Century Cures Act, one of the last bills on the table before the new Congress is sworn in this January.
On Monday industry groups continued to examine the 996-page draft of the new biomedical innovation package known as the 21st Century Cures Act that Republicans introduced over the weekend. A vote is scheduled for Wednesday, although tensions remain and Congress has yet to find the funding to pay for the provisions.
The bill, known as the 21st Century Cures Act, is the product of years of debates over health care policy issues, including how to track the federal drug regulatory structure with the fast-paced world of biotechnology, streamline the unwieldy mental health care system, and stem the widespread and intractable problem of opioid drug abuse.
But critics say the act contains a number of regulatory changes that could profoundly reshape the way some drugs and medical devices are approved in the United States, making the process less costly and time consuming for companies, but also potentially less safe for patients.
The 21st Century Cures Act now being refined by the lame-duck Congress is one of the most-lobbied health care bills in recent history, with nearly three lobbyists working for its passage or defeat for every member on Capitol Hill.
Despite the potential for challenges in the Senate, the House will push ahead and vote Wednesday on the $6.3 billion legislation. It would give states $1 billion to fight the opioid crisis, in addition to providing $4.8 billion for continuing three signature Obama administration research programs over the next 10 years: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative.
The Cures Act, which passed the House by a landslide in July 2015, has been the focus of dozens of congressional hearings and endless debate among Republicans and Democrats over the past three years.
Leaders from both parties have called passage of the Cures bill the most important thing Congress could do this year. Both Alexander and Upton consider it their legacies. Although Alexander will remain chairman of his committee next year, Upton will have to step down.
But there has been a major sticking point: While the House version of the bill included funding for medical research, which the Democrats required for their support, Senate Republicans on the HELP committee would not approve funding without an agreement over where the money would come from.
The lack of financing caused a stalemate until the unexpected happened: The Affordable Care Act was mortally wounded by the election of Donald Trump. With huge chunks of Obamacare now likely to be repealed, Democrats have agreed to underwrite the Cures Act with some money from the ACA, and some to be generated by sales of part of the Strategic Petroleum Reserve.
“What we have in the 21st Century Cures Act is an innovation game changer, a transformational bill to bring our health infrastructure light years ahead,” said Upton and Alexander.
The Democrats have been silent on the so-called final version of the Cures Act. They have long been worried about provisions to speed the Food and Drug Administration’s approval process — concerns that have increased with the election of Trump, who has said he plans to reduce government regulation.
Three years in the making, 21st Century Cures is designed as a broad investment in medical research and development at the National Institutes of Health and the U.S. Food and Drug Administration, coupled with the loosening of bureaucratic red tape and regulatory restrictions. Its authors have tinkered with the sources of funding and the language of the legislation. And, in the process, they’ve encouraged lawmakers to offer their support by adding specific, popular provisions to the final product.
One of those provisions was funding to tackle the opioid epidemic, a development that seemed unlikely to transpire as recently as several months ago.
Deaths from opioid overdoses have continued to rise in many communities across the country, and existing treatment systems are outdated and ill-equipped to address the influx, making the need to address the crisis a political imperative. Over the summer, President Barack Obama had signed the Comprehensive Addiction and Recovery Act into law, a bipartisan bill that contained several hopeful developments, such as expanding access to medication-assisted treatments — but included essentially no funding to implement the proposals.
So earlier this month, Sens. Jeanne Shaheen (D-N.H.) and Ed Markey (D-Mass.) began a push to include opioid-related funding in the 21st Century Cures legislation, reminding lawmakers that Congress has yet to help states contain the growing crisis. Last week, they were joined by Sens. Tammy Baldwin (D-Wis.) and Joe Donnelly (D-Ind.) in writing a letter urging Senate Majority Leader Mitch McConnell (R-Ky.) and Minority Leader Harry Reid (D-Nev.) to take action.
“As the end of the year fast approaches, it is past time for Republicans and Democrats to come together to provide emergency funding and increase investments in prevention and treatment services for opioid use, misuse, and use disorders,” the letter read. “Until we do, our job is not done and our communities will continue to hurt.”
FDA reforms, along with new funding for the National Institutes of Health, were the core of the bill when it was first considered in 2015. The latest iteration includes $500 million over 10 years to help the FDA speed the approval of drugs and medical device, which the pharmaceutical industry has cheered. Consumer advocates, however, say the changes will expose patients to products that haven’t been appropriately vetted.
Mental health advocates praised the potential inclusion of legislation from Rep. Tim Murphy (R-Pa.) to reform mental health treatment. The House will vote Wednesday on whether to include several provisions from the Mental Health Reform Act with the Cures Act.
These include creating the position of assistant secretary for mental health and substance abuse within HHS’ Substance Abuse and Mental Health Services Administration and efforts to improve coordination and oversight of mental health programs. It also would add several grant opportunities for states and communities.
John Snook, president of the Treatment Advocacy Center, said the Cures Act will likely now include several important mental health and substance abuse provisions that show Congress is acknowledging there is a mental health crisis that needs to be addressed.
“The overarching message is that we’re really pleased that the focus on severe mental illness has continued,” he said.
Snook said he was particularly pleased to see included aspects of the Mental Health and Safe Communities Act from Sen. John Cornyn (R-Texas) that would help create and expand programs that divert people away from incarceration and toward treatment for mental illness and substance abuse.
“We don’t want to lose this momentum,” Snook said. “There’s so much to do, and with a new Congress you never know what’s going to happen.”
But while the opioid funding has helped draw Democrats to support 21st Century Cures, other provisions, including the removal of a mandatory funding stream for medical research investments, have driven some lawmakers away.
Among the bill’s major opponents is Sen. Elizabeth Warren (D-Mass.), who on Monday announced that she will not vote for the bill, despite supporting much of its content, because it has been one of the most heavily lobbied health care bills.
Warren said Senate Republicans “let Big Pharma hijack the Cures bill” and accused them of “trying to buy off Democratic votes one by one by tacking on good bipartisan proposals that senators in both parties have worked on in good faith for years.”
“This final deal has only a tiny fig leaf of funding for NIH and for the opioid crisis,” she said on the Senate floor. “And most of that fig leaf isn’t even real. Most of the money won’t be there, unless future Congresses pass future bills in future years to fund those dollars. So why bother with a fig leaf in the Cures bill? Why pretend to give money to NIH or opioids? Because this funding is political cover for huge giveaways to giant drug companies.”
One concession to drug companies had Sen. Chuck Grassley (R-Iowa) joining Warren in opposing the bill in its current form. Grassley said he would object to taking up the bill in the Senate unless exemptions to the Physician Payments Sunshine Act he co-authored were removed. The Sunshine Act, part of the Affordable Care Act, created a database of drug and device company payments to physicians. The Cures Act would remove the reporting requirement for continuing medical education, or CME; medical journal reprints; and textbooks, as well as exempt doctors who receive indirect payments for speaking fees.
“With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever,” Grassley said in a statement. “Watering down sunshine provisions is counterproductive and goes against the trend in healthcare to have more transparency, not less.”
“This is all in the category of dumbing down the criteria for drug approval,” said Dr. Jerry Avorn, a professor of medicine at Harvard. “It’s a lower bar and shorter race.”
Democrats, conceding the legislation makes more changes to regulations than they sought, note that the bill has fewer changes than an earlier version out of the House, and far fewer than they would expect in the next Congress. People who support the bill say it simply codifies quicker pathways that the Food and Drug Administration was already using.
Beyond the pharmaceutical industry, the bill’s supporters include universities, medical schools and groups representing them, as well as patient groups funded by drug and device companies, said Diana Zuckerman of the nonprofit National Center for Health Research, which has not lobbied the bill but has launched a campaign to convince Congress to “fix” it.
Hospitals and medical schools, which oppose rising drug costs, supported the bill because the NIH funding could propel grants to medical and research institutions, Zuckerman said.
Johns Hopkins Medicine called enhanced biomedical research funding “long overdue.” Spokeswoman Jania Matthews said in an email that the bill would also “provide new tools at the FDA to accelerate the approval of new therapies and medical devices.”
The House is expected to vote on the 21st Century Cures Act on Wednesday, and the Senate will consider it next week.
For more, read:
“$6.3 Billion Measure Aims to Cure Ailing Health Care Policies,” NY Times, 11/28/16
“Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes,” STAT News, 11/27/16
“In A Stunning Development, Congress Drops A Billion Dollars On The Heroin Crisis,” The Huffington Post, 11/28/16
“‘Cures’ bill gains momentum with wish-list provisions,” Modern Healthcare, 11/28/16
“‘Cures’ Act in Congress Heavily Influenced by Lobbyists,” Kaiser Health News, 11/29/16
“A Bipartisan Victory for Medical Research in Congress,” The Atlantic, 7/13/15
“This Bill Increases Funding for NIH and FDA, So Why Doesn’t Everyone Love It?,” NBC News, 7/10/15