Revamped '21st Century Cures' Bill Up For House Vote

A bipartisan-backed new version of the 21st Century Cures Act, designed to accelerate medical device and drug approvals and boost research spending, is up for a crucial vote in the U.S. House of Representatives this week.

The House had passed the measure in July 2015, but disagreements over funding and persistent clamor against the landmark bill stalled it in the Senate. After much wrangling in the past year, House and Senate leaders announced late last week that they finally worked out a deal to pass a reworked bill, according to STAT.

Some details of the measure are still being hammered out to appease Senate Democrats, but a final version is expected to be put to a vote on Wednesday.

“America’s patients are waiting on us and we will deliver,” Republican Senator Lamar Alexander (R-TN), chairman of the Committee on Health, Education, Labor and Pensions (HELP), and Representative Fred Upton (R-MI), chairman of the Energy and Commerce Committee, said in a joint statement. “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."

The legislation provides the Food and Drug Administration (FDA) with $500 million over ten years to facilitate its regulation of drugs, devices, and biologics, and to beef up its workforce in the process. This requires FDA, among other things, to consider "real-world" evidence in lieu of "gold standard" clinical studies, as basis of product approvals.

The Act also earmarks $4.8 billion in funding over ten years for the National Institutes of Health (NIH) to boost research, including President Barack Obama's Precision Medicine Initiative, Vice President Joe Biden's Cancer Moonshot, and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

It also provides $1 billion over two years to address the opioid epidemic, as well as important provisions to increase access to mental health treatment.

"Policy improvements such as those contained in the revised 21st Century Cures legislative package will help strengthen that ecosystem and support the development of life-changing medical technology," Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), said in a statement supporting the new version of the 'Cures' bill.

“The package includes a number of important improvements to FDA’s medical device premarket program designed to increase the efficiency, predictability and transparency of the agency’s review process. The most significant of these builds on initiatives already underway within FDA to help create an expedited pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening or irreversibly debilitating diseases or conditions who have no or limited alternative treatment options," he added.

The majority of the legislation will be paid for with funds from the Prevention and Public Health Fund, and more than $1 billion in funding will be drawn from the Strategic Petroleum Reserve, according to Regulatory Affairs Professional Society (RAPS).

Consumer and patient advocacy groups who oppose the 'Cures' bill contend that "the medical research money is buying the Democrats’ acquiescence on important FDA safety matters," reports STAT.

“While there are positive aspects of this legislation, many provisions would severely weaken the FDA’s drug and medical device approval standards and seriously harm rather than help patients,” Jack Mitchell, director of government relations for the National Center for Health Research, which advocates for patient safety, told STAT. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”

After the House vote on Wednesday, both chambers of Congress could potentially pass the bill during the upcoming lame-duck session.

According to U.S. News and World Report, Senate Majority Leader Mitch McConnell (R-KY), has described the bill as "the most important legislation Congress will consider this year," and said the Senate will act after the House and before the end of December. President Obama reportedly is likely to sign the bill into law.

President-elect Donald Trump has vowed to work with Congress in "cutting the red tape at the FDA" and many sections of the 'Cures' bill are designed to streamline FDA's regulatory processes.

"I expect some type of FDA reform will likely surface once the Trump administration comes in, along with a certain level of continuity of initiatives begun under Obama, such as the Cancer Moonshot, and key Califf initiatives such as EvGen/RWE [evidence generation/real-world evidence]," writes Nancy Bradish Myers, president of Catalyst Healthcare Consulting, and a Washington, DC-based attorney with deep expertise in health care law and regulation, policy development, and government relations.