The Senate Health, Education, Labor and Pensions Committee on April 25 overwhelmingly approved the Food and Drug Administration Safety and Innovation Act, which includes American Hospital Association-supported provisions to help alleviate critical drug shortages. Sen. Bernie Sanders (I-VT) was the sole dissenter. The bill reauthorizes the law permitting FDA to collect user fees from makers of prescription drugs and medical devices, and allows the agency to begin collecting user fees for generic drugs.
In a letter on April 24, AHA and 14 other organizations representing clinicians, hospitals and patient advocacy groups voiced support for the drug shortage provisions, which strengthen requirements that drug makers report production interruptions and discontinuations to the FDA and give the agency other authority to prevent shortages and better communicate with stakeholders. “We remain hopeful that we can continue to work with the committee to address the lingering issues of Drug Enforcement Administration quotas, effective enforcement of the early notification requirement, and ensuring FDA has the resources it needs to maintain the supply of safe, effective medications that our patients rely on,” the groups said.
The House Energy and Commerce Health Subcommittee plans to mark up its version of the user fee reauthorization bill on May 8.