A bill the House passed overwhelmingly allowing for accelerated drug approvals is expected to pass the Senate next week despite some lingering opposition in that chamber.
The 21st Century Cures Act sailed through the House Wednesday Nov.30 with overwhelming bipartisan support, building momentum for a vote in the Senate.
The strong support in the Senate is the result of a combination of debate and appeasement. The bill had been stuck in the Senate since last year following the House's blessing on a 344-77 vote. The legislation, which at the time was 352 pages, got sidetracked as both Republicans and Democrats stood their ground on issues they disagreed with while adding on to the bill in a manner which resembled hanging ornaments on a Christmas tree. The bill that passed out of the House yesterday was 996 pages long.
That version was rolled out earlier this week after Democrats allowed changes at the Food and Drug Administration over accelerated approvals but also insisted on inclusion of a funding package for the National Institute of Health and the FDA. Deficit hawks across the aisle said the increased funding was out unless there were provisions stipulating where the cash came from. The money will now come from sale of the oil from Strategic Petroleum Reserve as well as prevention programs contained in the Affordable Care Act.
Moving on a 392-26 vote, the legislation had something for everyone. The Obama administration saw a trio of its research programs funded over the next decade. Vice President Joe Biden's high profile cancer moonshot, the Precision Medicine Initiative and the BRAIN Initiative all will receive support via $4.8 billion earmarked for the National Institute of Health. Another $1 billion is included to fund opioid abuse, which has become a health crisis in states like West Virginia, Kentucky and New Hampshire. And the Food and Drug Administration picks up $500 million that will go in part for additional staffing in the hopes that it can hire talent from the private sector and that the process by which drugs and medical devices are examined can be accelerated.