The U.S. Senate voted 94-1 to approve two pieces of health-care legislation: one that continues the U.S. Food and Drug Administration’s (FDA) authority to collect user fees and another that expands access to experimental treatments for patients with terminal illnesses.
The bipartisan HR 2430 bill, known as the FDA Reauthorization Act of 2017, reinstates the FDA’s fee-collection authority (which was set to expire September 30, 2017). The fees comprise nearly $2 billion of the FDA’s annual $5 billion budget and help pay for the federal review of drugs and medical devices. The bill also included a proposal to limit price increases for established prescription drugs that have no competition and require companies to provide data on how drugs for adult cancer patients could treat children. Though the White House administration pushed Congress to renegotiate and increase the fees, President Trump is expected to sign the bill into law.
The “Right to Try” bill will introduce national standards and methods to help patients with terminal illnesses access drugs that aren’t yet approved by the FDA. Current compassionate use laws allow patients to access these drugs, but pharmaceutical companies often refuse requests for fear of liability.
Sources: The New York Times, August 3, 2017; STAT News, August 3, 2017.