Senator Bernie Sanders (I-Vt.) and Edward Markey (D-Mass.) placed a hold on the appointment of prominent cardiologist and researcher Robert Califf, MD, as the FDA commissioner.
Markey said in a statement that he wanted immediate reforms to the FDA’s approval process for opioid painkillers. He asked for the FDA to convene advisory committees for opioid-approval questions, consider addiction, abuse and dependence when determining if opioids are safe and rescind the approval of OxyContin for children.
“While people in every community across the country are dying every day from opioid overdoses, the FDA continues to operate as if safety just means the right dose when it should include all the dangers of these painkillers,” Markey said. “Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs. The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination. Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family.”
Sanders said in a statement that he was concerned with Califf’s ties to the pharmaceutical industry. Before joining the FDA in February 2015, he served as vice chancellor of clinical and translational research at Duke University, a cardiology professor at Duke and founder of the Duke Clinical Research Institute, the world’s largest academic research organization.
“I share Sen. Markey’s concerns that the FDA must change the way it approaches addiction. Too many Americans are dying from what has become an opioid epidemic,” Sanders said. “I also strongly believe that at a time when millions of Americans cannot afford to purchase the prescription drugs they require, we need a leader at the FDA who is prepared to stand up to the drug companies. We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.”