California Gov. Brown Rejects Right to Try Bill
Democratic California Gov. Jerry Brown vetoed a bill that would have allowed drugmakers to make experimental therapies available to terminally ill patients if recommended by two doctors, saying the FDA’s compassionate use program should be given a chance to work.
Brown agreed that patients with no other options should be able to try investigational drugs, but said the FDA’s February draft guidance streamlining its CU program already allows this to happen. Under the revised guidance, physicians could apply for a patient to access a firm’s compassionate use program in 45 minutes, rather than the current 100 hours.
If that process was still too slow for emergency situations, a phone call could be made to an appropriate FDA review division, which would provide authorization over the phone.
Right-to-try laws have been adopted in 24 states. The Goldwater Institute, which designed the California law, issued a statement expressing disappointment with Brown’s veto.
In July, Rep. Matt Salmon (R-Ariz.), introduced federal RTT legislation. That bill, H.R. 3012, has been referred to the Energy and Commerce Committee health subcommittee and the Judiciary Committee’s subcommittee on crime, terrorism, homeland security and investigations. — Kellen Owings