- The U.S. Senate on Wednesday passed the 21st Century Cures Act by a bipartisan vote of 94 to 5 in favor, sending the sweeping legislative package to the President's desk a week after the House of Representatives green lit the bill in a similarly overwhelming vote.
- President Obama has said he plans to quickly sign the bill into law, highlighting the $4.8 billion in new funding for the National Institutes of Health as well as the roughly $1 billion in grants to States to fight the opioid overdose epidemic.
- Despite the widespread support, the bill is not without controversy. All that money, which is spread across 10 years, is not guaranteed and will have to be appropriated by Congress each year. Reforms aimed at speeding drug approvals through the Food and Drug Administration have also sparked concern.
The Senate's passage of 'Cures' on Wednesday marked a close to more than two years of legislative wrangling over the biomedical bill.
With President-elect Donald Trump set to take office in January, 'Cures' will be one of the last pieces of legislation President Obama will sign into law.
Obama secured investments in many initiatives sponsored by his administration, such as $1.8 billion towards Vice President Joe Biden's Cancer Moonshot. Roughly $3 billion will go towards the BRAIN and Precision Medicine projects.
A major point of contention, however, is the provisions designed to reform the FDA approval process. Supporters argue the bill will help get cutting-edge advancements to patients faster, while critics have raised concerns the bill will undermine the FDA's standards for establishing drug efficacy.
For example, Section 3022 orders the Department of Health and Human Services (which oversees the FDA) to establish a program to evaluate the potential use of real world evidence to support approval of a new indication of an already approved drug. The HHS Secretary must set up a draft framework for implementing such a program no later than 2 years after the Act is enacted.
In this case, real world evidence is defined as data derived from sources other than randomized clinical trials, which some believe de-emphasizes the so-called "gold standard" by which the FDA has typically evaluated drugmakers' products.
Former Democratic presidential candidate and Senator Bernie Sanders, I-VT, blasted the bill as cop-out to the pharmaceutical industry, re-iterating his calls for legislation addressing high prescription drug prices.
Senator Elizabeth Warren, another vocal critic, acknowledged the bill moved forward many helpful initiatives but tweeted her disappointment that to secure NIH funding Democrats had to compromise on regulatory standards.
Republicans concluded that bipartisan medical innovation in the #CuresAct would require a raft of giveaways to giant drug companies.— Elizabeth Warren (@SenWarren) December 8, 2016
Still, not many of Sanders and Warren's Democratic colleagues joined in their opposition to Cures. Only 5 Senators voted against the bill: Sanders; Warren; Mike Lee, R-UT; Ron Wyden, D-OR; and Jeff Merkley, D-OR.