Major FDA reform bill heads to Obama’s desk
The Senate overwhelmingly approved a sweeping medical innovation package Wednesday afternoon, pledging billions of new dollars for research and long-delayed resources for combating the nation’s deadly opioid epidemic.
The $6.3 billion 21st Century Cures Act, which funds some of the outgoing Obama administration’s top research priorities, has been relentlessly driven by House Energy and Commerce Chairman Fred Upton for nearly three years.
The bill, approved in a 94-5 vote, also includes a host of industry friendly reforms to FDA’s drug and medical device review process — some controversial — in addition to the research and opioid funding that drew a majority of Democrats to support it. It also provides a major update to mental health care policy, but provides no new funding for those programs.
The bill includes $1.8 billion for the Cancer Moonshot Initiative. The program aiming to speed up the pace of cancer research on Monday was renamed for Vice President Joe Biden’s son, Beau, who died of brain cancer last year.
The bill passed the House last week, following months of intense negotiations between White House officials and a bipartisan group of top health care lawmakers in both chambers. With Congress expected to wrap up its work for the year this week, the vote will help send lawmakers out of town on a high note, after a divisive election and ahead of a brutal fight to repeal Obamacare next year.
President Barack Obama is expected to quickly sign the legislation — one of the final bills of his administration, cementing a health care legacy that extends beyond the Affordable Care Act. The stopgap government funding bill introduced in the House on Tuesday night would provide $872 million for Cures this fiscal year.