Long-Stalled FDA Reform Sits on Senate’s Lame-Duck Calendar

“Let’s do it now,” said Marc Boutin, CEO of the National Health Council, a nonprofit that represents about 50 patient-support and disease organizations and gets funding from drug and device companies. “This legislation will enhance research, speed cures to market and benefit public health.”

The Obama administration had previously been supportive of lawmakers’ work, as long as the final package were to include funding for its “cancer moonshot” and Precision Medicine Initiative. The White House Tuesday declined to comment on the legislation’s current progress.

Some congressional leaders say the legislation is an opportunity for Republicans and Democrats to show they can work together after a divisive election. Senate Majority Leader Mitch McConnell, R-Ky., and House Speaker Paul Ryan, R-Wis., said earlier this month that the measures are a priority during the lame-duck session.

“Congress should not squander this rare opportunity to get a result on behalf of millions of patients who are waiting for us to deliver on the promise of 21st Century Cures,” Sen. Lamar Alexander, R-Tenn., said in a statement. Alexander chairs the Health, Education, Labor & Pensions (HELP) Committee and has led the Senate’s supporters.

But Sen. Patty Murray, D-Wash., the committee’s ranking member, and other Democrats are pushing for even broader legislation. They would include more funding for opioid addiction treatment under a law passed in July and mental health reform approved in the House and by the HELP committee but not yet taken up by the full Senate.

Both could complicate agreement on FDA changes and NIH funding, essentially making the bill into an omnibus health care measure. Paying for the legislation remains an issue; the House would fund it partly by selling oil from the nation’s Strategic Petroleum Reserve. Republicans in the past have insisted that the final package’s cost be fully offset and subject to annual appropriations. Democrats have balked at that and argued for a firmer long-term funding commitment.

Meanwhile, some Senate Democrats have also reportedly asked for a larger increase in FDA resources than the House bill proposes, arguing that $550 million over five years is not enough to cover the agency’s greater responsibilities.