Reworked '21st Century Cures Act' to get vote in House

A new version of legislation aimed at speeding up regulatory approval for medical devices and drugs will get a vote in the House this week.

The 21^st Century Cures Act had passed the House by a wide margin in 2015, but never advanced in the Senate as the chamber broke the bill into separate pieces of legislation. The revamped proposal is now described as a $6.3 billion “medical innovation package” including increased funding for the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Obama administration’s Precision Medicine Initiative.

“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 to best match the incredible breakthroughs that are happening by the day. And it is critical to remember that passing 21st Century Cures is the best way to ensure some of this funding occurs immediately in Fiscal 2017,” sHouse Energy and Commerce Committee Chairman Fred Upton, R-Michigan, and Senate Health, Labor, Education and Pension (HELP) Committee Chairman Lamar Alexander, R-Tennessee, said in a statement.

Along with the research funding, the package includes $1 billion for state grants to address opioid abuse and programs to improve mental health care, such as screening pregnant women for depression.

While Upton and Alexander promised a House vote on the bill Wednesday, Senate Democrats are still negotiating what its own version of the legislation would like, according to STAT News. Despite the changes made to the bill, some interest groups are still against it, citing the potential danger of expediting FDA approval of devices and using so-called “real world evidence” over the results of clinical trials.

“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, said to STAT News. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”

There was intense lobbying both for and against the earlier version of the bill. According to Kaiser Health News, more than 1,450 lobbyists representing more than 400 organizations working for its passage or defeat. Pharmaceutical Manufacturers and Research of America (PhRMA) alone spent about $30 million pushing the bill.