A major proposed law that alters the way the Food and Drug Administration (FDA) approves drugs and medical devices has been wending its way through Congress since 2014. Momentum is building on Capitol Hill to pass the legislation in the current “lame-duck” session of Congress.
That shouldn’t happen.
The House passed its version of the legislation—the 21st Century Cures Act (hereafter the Cures bill) —in July 2015. The Senate health committee created and passed 19 related bills, under the banner “Innovation for Healthier Americans,” this past spring.
Sen. Lamar Alexander (R-Tenn) pushed, without success, to get the legislation to the Senate floor this past summer. Now, he and proponents—which include the pharmaceutical and medical device industries and dozens of research and patient groups who get support from those industries—seek to pass the legislation in the lame-duck session.
The election of Donald Trump may add to momentum to pass the legislation now, or undermine its chances both now and in 2017. It’s not yet clear.
Proponents’ main arguments for lame-duck passage are:
(a) The need to foster innovation at the FDA and bring new drugs and devices to market sooner;
(b) The House bill would increase funding for NIH, by $9 billion over 5 years;
(c) The Obama administration’s “cancer moonshot” and precision medicine initiatives dovetail with the intent of the House legislation, and funding for both may be folded into any final legislative package;
(d) Americans expressed anger at their government in the election and Congress should pass this bipartisan legislation to demonstrate that lawmakers can work together to get things done.
Some provisions of the House and Senate bills take steps in the right direction. And I join the overwhelming chorus of voices supporting increased funding for medical research and FDA.
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