January 27, 2016

Manchin Will Filibuster FDA Nominee Robert Califf for Big Pharma Ties

Washington, D.C. – U.S. Senator Joe Manchin (D-WV) announced today that he will filibuster the Obama Administration’s nominee, Robert Califf, to be the next Commissioner of the U.S. Food and Drug Administration (FDA) because of his strong ties to the pharmaceutical industry. Senator Manchin believes that, with his long-term, significant ties to the pharmaceutical industry, Dr. Califf is not the champion the FDA needs to tackle this deadly epidemic, especially given the FDA’s failure to seriously address the prescription opioid crisis and properly weigh the risk of addiction and overdose death when approving ever stronger and more dangerous opioid drugs. Senator Manchin will use his time during the filibuster to read letters on the Senate floor from West Virginians that are suffering from the devastating effects of opioid abuse themselves, in their families and in their communities.

“The effectiveness of the FDA is a critical part of curbing our nation’s prescription drug abuse epidemic,” Senator Manchin said. “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. For this reason, I will filibuster Dr. Califf’s confirmation as the FDA Commissioner. 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.”

In 2014, 18,893 people died due to a prescription opioid overdose; that is 51 people every day. 16% more people died in 2014 than 2013. We’ve lost almost 200,000 Americans to prescription opioid abuse since 1999. Senator Manchin has made it one of his top priorities to stop this epidemic. To review a timeline of Senator Manchin’s efforts to curb opioid abuse, please click here.

Summary of Concerns with Dr. Robert Califf’s Appointment to be FDA Commissioner:

• Dr. 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.

• Dr. 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, Dr. Califf told an audience of executives that the American system for developing drugs and medical devices was in crisis and required disruption and transformation. Towards 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, the FDA’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.