5 Things to Know About the 21st Century Cures Act

In a show of bipartisanship, the House of Representatives overwhelmingly passed the 21st Century Cures Act on November 30 by a vote of 392-26. The bill includes funding for President Barack Obama’s Precision Medicine Initiative (PMI) and Vice President Joe Biden’s Cancer Moonshot, as well as prevention, treatment, and recovery programs for substance abuse and mental health disorders.

Here are 5 things to know about the legislation.

1. The bill has been in development for more than 2 years

The US House Energy and Commerce Committee kicked off the development of the Cures Act with the 21st Century Cures Initiative in April 2014. One of the founding ideas was to speed up the pace of drug approvals for diseases that do not have cures. In May 2015, the committee approved the bill, which is co-authored by Fred Upton, R-Michigan, and Diana DeGette, D-Colorado.

2. The bill provides funding for 10 years to PMI and the Moonshot

The bill includes provisions to support the Moonshot and PMI. The Moonshot was initially launched with $1 billion, but its future is dependent on continued funding from Congress that will come through the Cures Act.

3. Both parties are trying to get the bill passed

The Cures Act is one of those few efforts with broad bipartisan support. And with the uncertainty that came after Donald Trump’s election, the House and the Senate seemed determined to pass the bill before the end of the year.

Senate Majority Leader Mitch McConnell, R-Kentucky, said before the election that he was committed to passing the bill in the lame-duck session.

4. However, there may be some resistance in the Senate

The bill may have passed the House, but now it goes on to the Senate, where Elizabeth Warren, D-Massachusetts, is pushing back. She claimed that the pharmaceutical industry has “hijacked” the bill and she would not support the legislation.

Still, the bill is expected to pass the Senate, too.

5. There are concerns over the quicker FDA approval process

While the bill is trying to ensure patients have faster access to innovative treatments, there are some groups that are concerned the tradeoff may be patient safety. The bill does include clauses to keep the approval standards of the FDA intact, but in a Health Affairs blog, 2 experts raised concerns that the bill’s provisions could lead to “widespread use of new and costly treatments before they are shown to work or before their risks to patients are adequately known.”