U.S. Lawmakers Tackling Revamped 'Cures' Bill In Lame-Duck Session

Lawmakers from both chambers of the United States Congress, during an upcoming lame duck session, seek to advance a stripped-down version of a key bill that will overhaul current regulatory practices of the U.S. Food and Drug Administration (FDA) and increase research funding for the National Institutes of Health (NIH).

The U.S. House of Representatives, in July last year, passed the 21st Century Cures Act, which is designed to streamline the FDA's review of drugs and devices to advance medtech and biomedical innovation, as well as bring life-saving therapies to patients faster. It also earmarked $8.75 billion worth of investments in NIH grants over the next five years, which proponents say is needed to jumpstart stagnant U.S.-based research.

The measure, however, transitioned in the Senate to a “biomedical innovation” bill with 19 different pieces of companion legislation, and most recently came to a standstill because of a disagreement over funding, according to the Regulatory Affairs Professional Society (RAPS). The pieces of legislation were advanced earlier this year by the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, but have not been put on a vote by the whole Senate.

Senate Majority Leader Mitch McConnell (R-Ky.) and Speaker Paul Ryan (R-Wis.) said in late September that the "Cures" legislation will be a top priority in the lame-duck session after the election, reports The Hill. House Minority Leader Nancy Pelosi (D-Calif.) later also said she thinks the bill will pass.

“My own personal priorities are funding the government and the 21st Century Cures bill, which I think could end up being the most significant piece of legislation we pass in the whole Congress,” McConnell reportedly said in a press conference. “The president’s interested in it, precision medicine; the vice president’s interested in it, cancer moonshot; I’m interested in it, regenerative medicine. There are a lot of us who are deeply invested in that, and I think that will be a top priority in the Senate in the lame-duck as well as funding the government.”

The nearly $9 billion proposed funding for NIH remains the main stumbling block against the bill's passage. Opposing Republican senators have said that NIH needs to restructure its budget first before receiving additional funding.

A new version of the legislation, which Energy and Commerce Chairman Fred Upton (R-Mich.) said would be released this month, is still likely to include funding for NIH in order to bring Democrats on board, albeit with a lowered amount, reports RollCall.

Also, about a dozen patient advocacy and union groups said last week that the legislation should not be considered in the upcoming lame-duck session, but instead be reworked to include provisions that address rising prescription drug prices, according to Modern Healthcare.

Ellie Dehoney, VP of policy and advocacy at Research America, told the publication that prescription costs should be addressed in separate legislation, so that bipartisan-backed provisions in the 21st Century Cures Act — that have been in the works for years — can be put into law as soon as possible.

The Hill reports that Republicans on the Energy and Commerce Committee still are working on a new version of the contentious legislative package. A committee spokesperson reportedly said last week, "We're proud that the original 21st Century Cures Act that passed the House with overwhelming bipartisan support would deliver safe and affordable cures — and we continue working closely by the day with our House and Senate Republicans and Democrats counterparts, as well as the White House, to ensure the final package achieves these important goals. “We are making great progress – and working together, we will follow through in delivering hope.”