Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
Note: Over the weekend, the U.S. House of Representatives Energy and Commerce Committee announced the release of revised “False Hope” legislation.
Public Citizen strongly opposes the newest version of the “False Hope” Act (the “Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018”). Although the legislation has several improvements over the U.S. Senate-passed version (S. 204), the bill still has fundamental flaws that would put vulnerable patients at risk and undermine their rights.
In particular, the bill still would offer false hope to patients by creating a dangerous pathway for access to experimental medications and biological products that bypasses the U.S. Food and Drug Administration’s (FDA) existing Expanded Access program. That program provides for FDA review of experimental therapies used outside the context of a clinical trial, thereby helping to ensure that proposed uses of the treatments do not pose unacceptable risk.
The bill also would broadly immunize from liability manufacturers, sponsors, physicians, clinical investigators and hospitals for a wide range of conduct related to the provision of experimental medications to patients, including provision of such medications under the FDA’s existing Expanded Access program. In this way, the bill would bar suits in a variety of situations in which state law might reasonably impose liability and would eliminate a strong incentive for manufacturers and health care providers to act responsibly and in the best interests of patients.
Public Citizen urges House lawmakers to reject this newest legislation and go back to the drawing board.