January 29, 2016

Opposition Grows Against Nomination for FDA Chief

Presidential candidate Sen. Bernie Sanders (D-Vt.) is the most prominent of three Democrats and a Republican in the Senate to announce formal holds on the nomination of Robert Califf, MD, as the next commissioner of the Food and Drug Administration (FDA).

Sanders announced his opposition Jan. 26 based on concerns about Califf’s ties to the drug industry and his alleged lack of public commitment to lower pharmaceutical prices. Lower drug prices for all Americans are a key theme of Sanders’ 2016 presidential campaign platform. Califf currently serves as deputy commissioner of the FDA Office of Medical Products and Tobacco.

Sen. Joe Manchin (D-W. Va.) and Sen. Ed Markey (D-Mass.) also placed formal holds on the Obama administration nominee this week. Manchin said he was also motivated by Califf’s pharmaceutical industry ties as well as questions about FDA’s oversight of prescription painkillers.

Markey’s formal hold is intended to pressure the FDA to reverse its recent decision to allow doctors to prescribe OxyContin to children. The Massachusetts senator believes over-prescribing of OxyContin and other addictive opioids is a primary contributor to a growing heroin epidemic gripping the nation. He is concerned this recent regulatory decision will exacerbate the problem, especially among younger patients.

Sen. Lisa Murkowski (R-Alaska) was the first senator to place a hold on Califf’s nomination. She said her action stems from the agency’s reluctance to require labeling of genetically modified salmon.

Although the Health, Education, Labor, and Pensions (HELP) Committee approved the Califf nomination by voice vote earlier this month, his confirmation by the full Senate now faces an uphill struggle because of issues raised by Sanders, Manchin, Markey and Murkowski. Senators often use formal holds to force specific legislative concessions. Presidential nominations cannot be put forward for a vote in the Senate until all formal holds are released.

Members of the American College of Radiology (ACR) are urged to closely monitor the Advocacy in Action newsletter for the latest developments surrounding Califf’s pending nomination.