FDA Policy/General

Senator Manchin to Filibuster Califf Confirmation Vote

David McFarland

— 2 min read
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As FDA commissioner nominee Robert Califf moves closer to a full Senate confirmation vote, another lawmaker has announced opposition to the appointment. This time it is Sen. Joe Manchin (D-WV), who says he will filibuster Califf’s nomination because of his strong ties to the pharmaceutical industry. Manchin says Califf is “not the champion” FDA needs to tackle the “deadly epidemic” occurring with prescription opioid products. He says he will use his time during the filibuster to read letters on the Senate floor from West Virginians who are “suffering from the devastating effects of opioid abuse themselves, in their families and in their communities.”

Earlier, Sen. Bernie Sanders (I-VT) placed a hold (see story) on FDA commissioner-nominee Robert Califf’s confirmation because of his close ties to the pharmaceutical industry and lack of commitment to lowering drug prices. A separate hold was placed by Sen. Edward J. Markey (D-MA), who called for immediate reforms to the agency’s approval process for opioid painkillers (see earlier story). And Sen. Lisa Murkowski (R-AK) has pledged to hold up the confirmation on the Senate floor until she has reassurances from FDA that genetically modified salmon will be labeled as such.

“The FDA and Commissioner’s number one priority should be public health and it is inappropriate for the FDA Commissioner to have had such close financial ties with the pharmaceutical industry,” Manchin said in a release. “We need to change the culture of the FDA, and that will not happen if the person at the helm is not a champion who is committed to pushing back against the pressure to continually approve new opioid medications given the significant risks to public health. Now more than ever, the FDA commissioner is an important figure in the fight against prescription drug abuse, something that has ravaged my state of West Virginia and the entire nation. Dr. Califf’s past involvement will have an impact on his effectiveness and leadership capabilities, and I cannot, in good conscience, allow his confirmation.”

Manchin summarized the following concerns with Califf:

  • Califf’s 2014 financial disclosure listed seven drug companies and one device maker that paid him for consulting and six others that supported his university salary. Between 2010-2014, he received money — either through his university salary or consulting fees — from 26 separate pharma companies, including opioid manufacturers.
  • Califf has served as a board member and consultant to Faculty Connection LLC. This is a firm that has worked with over 175 different pharma, biotech, and medical device firms and touts the experience of its consultants in influencing the FDA.
  • In May 2014, Califf told an audience of executives that the American system for developing drugs and medical devices was in crisis and required disruption and transformation. Toward the end of his talk, he put up a slide that identified a key barrier to change: regulation. He described regulation as a “barrier,” not a safeguard for public health.
  • In 2008, agency’s approval of new marketing claims for existing drugs was 56%. In the first 8 months of 2015, it was 88%. This includes approving OxyContin for use in children as young as 11.

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