Lawmakers Face Tug-of-war Over 21st Century Cures Bills
Medical research groups are urging House and Senate leadership to pass the 21st Century Cures Act when they return to work in November. In a letter to Congress, United for Medical Research (UMR) said the bill’s funding increases for the National Institutes of Health (NIH) are too important to delay any further. A similar letter from Research America says that by “applying supplemental funding for NIH and FDA and pursuing efficiencies in the R&D pipeline, the Cures initiative will empower our nation to find safe and effective solutions to health threats more quickly, and deliver those solutions to patients more efficiently.”
The calls to pass the legislation come on the heels of a letter from 13 liberal groups, including Public Citizen, Center for American Progress, and the AFL-CIO, urged lawmakers to not advance the 21st Century Cures Act during the lame duck session and instead work to improve this legislation in the next session. “Over the last year, a series of instances of price gouging by pharmaceutical corporations has led various congressional committees to look into these practices; these efforts included several high-profile hearings and Senate Finance Committee investigations,” the groups wrote. “While the Cures Act’s funding for the National Institutes of Health is a priority for many, it is critical that any legislation making changes to drug policies take steps to rein in the cost of prescription drugs.”
The liberal groups say they have several concerns about the legislation’s provisions to speed FDA approval based on limited information and to extend exclusivity periods for certain drugs. “Such provisions may undermine the agency’s ability to ensure the safety and quality of products and could reduce access to prescription drugs,” they wrote. “Moreover, these policies are generally unnecessary, given that the FDA already approves a significant share of drugs through expedited pathways. In fact, the FDA’s current extensive use of such pathways is already raising serious safety concerns. But notwithstanding these provisions, moving forward with this legislation now would be a missed opportunity to address unaffordable prescription drug prices. There is no justification for moving forward with legislation that provides substantial benefits to the drug industry without asking for something in return.”