21st Century Cures May Be on Fast Track
[Report by John Hope] Congressional observers see the possibility that a lame duck session of Congress opening 11/14 will fast-track approval of the 21st Century Cures legislation that has made its way in companion bills through both the House and Senate. With Republican control of both the House and Senate now assured for the next two years, lawmakers may be ready to pass what they see as a signature piece of legislation for the current Congress, despite calls at the end of October from politically liberal and progressive groups that action on it should be deferred until the new administration is in place, calls likely based on an assumption that Hillary Clinton would be president-elect and that there would be a shift in the power balance in Congress. The 13 groups that spoke out said they wanted to see the measure reworked to tackle rising prescription drug costs. They also raised concerns about bill provisions to speed FDA approvals based on what they consider to be limited information and to undermine exclusivity periods for certain drugs.
Advocates for organizations who are eager for the additional funding for research included in 21st Century Cures argued that the measure should be passed now and the question of prescription drug prices held for legislative action in the next Congress.
The complex measure has been controversial since its introduction, particularly due to provisions that critics say would endanger public health by speeding approvals of drugs and medical devices too much. A 2015 analysis in Nature Medicine said that the bill could relax processes in place to require scientific evidence for drug and device approvals. “The 21st Century Cures Act aims to accelerate the delivery of drugs and devices to patients,” it said, “and this is important and laudable. But valuing speed over safety and efficacy gives cause for concern.” The article quotes FDA officials as saying that the bill’s language must strike a balance between making new products available to those who need them while also preserving the agency’s high standards.
But some critics, such as former FDA commissioner David Kessler aren’t so sure. In a 2015 New York Times op-ed, Kessler raised the possibility that the bill could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death. “While the legislation does not mandate this approach,” he wrote, “it opens the door to it.”
Before the election recess, Senate majority leader Mitch McConnell (R-KY) indicated that his personal priorities in a lame-duck session would be funding the federal government for the fiscal year that began 10/1 and passing the 21st Century Cures Act, which he said “could end up being the most significant piece of legislation we pass in the whole Congress.” House speaker Paul Ryan (R-WI) was quoted before the election as saying that the legislation would be among “very important key initiatives” that he wanted to see completed in November.
Senate HELP Committee chairman Lamar Alexander (R-TN) has said he is “committed to getting a result this year that will lead to lifesaving medical breakthroughs and advance President Obama’s precision medicine initiative and Vice President Biden’s cancer moonshot.”
For the bill to become law, the Senate will have to approve its version and then join with the House in a conference committee to resolve differences.
American Medical Informatics Association vice president of public policy Jeff Smith said that while there is good reason to be optimistic that the bill will be considered and approved due to increased chatter about it coming up in the lame duck session and the support of McConnell and Ryan, funding issues could slow progress on it. “Passing a large bill with a significant price tag before a larger spending package that will be needed to avoid a shutdown [of the federal government] does not look good on paper,” he said.
Public comments on President-elect Donald Trump’s views on the legislation could not be found. He has spoken about rolling back some FDA regulations, especially in the area of food safety, and has complained about high prescription drug costs. Observers say that any large-scale changes to FDA would not come until several months into a Trump presidency at the earliest.
Early reports on the day after the election indicate that pharmaceutical and biotech stocks gained markedly as investors took comfort from the fact that Democrats would not be able to pursue action on drug pricing. A concern that there might be drug price controls has been lifted, observers said.