December 14, 2021

Manchin: How Many More Americans Have To Die Before We See A Culture Change At The FDA

Washington, DC – Today, U.S. Senator Joe Manchin (D-WV) released the following statement ahead of Dr. Robert M. Califf’s appearance before the Senate Health, Education, Labor and Pensions (HELP) Committee. Dr. Califf has been nominated to be Commissioner of the Food and Drug Administration (FDA).
“It is abundantly clear the FDA has failed to keep Americans safe. I can’t fathom why we would confirm someone whose actions failed to swiftly curb the tide of the opioid epidemic and protect the public’s health, especially someone who has already helmed FDA as its Commissioner. More than 500,000 Americans have died since the FDA first approved Oxycontin in 1995. During Dr. Califf’s previous tenure as FDA Commissioner, drug related overdoses went up. Five years later, they are up again, this time at a record number: there were more than 100,000 overdose deaths in the United States last year. Furthermore, Dr. Califf has indicated he plans to keep Dr. Janet Woodcock, who has led the FDA and directly overseen the approval of numerous highly addictive drugs to market, as part of FDA leadership. We need a leader who is ready for reform in pursuit of improving public health outcomes and Dr. Califf is not that candidate. How many more Americans have to die before we see a culture change at the FDA? If there was ever a time for a change in leadership at the FDA, an institution with such direct impact on the American people, it is now.”