Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
Note: Today, the U.S. House of Representatives passed S. 204, the U.S. Senate version of the False Hope legislation passed in August 2017. Read Public Citizen’s letter to lawmakers about the legislation.
The House of Representatives’ passage of S. 204, the Senate’s seriously flawed False Hope legislation, opens the gate to a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective. The House lawmakers who supported the bill ignored pleas from four former U.S. Food and Drug Administration (FDA) commissioners, hundreds of bioethicists and several dozen patient safety, consumer and physician groups. They also disregarded the fact that H.R. 5247, although flawed, would have provided stronger safeguards for patients than those provided by S. 204.
The bill passed today will expose vulnerable patients to risks of serious harm, including dying earlier and more painfully than they otherwise would have, without appropriate safeguards. To protect patients, Public Citizen urges pharmaceutical companies to make their experimental medications available to patients who are not enrolled in clinical trials only under the FDA’s much safer Expanded Access program.