Opioid Approvals by FDA Spur Senate Fight Over Nominee
The US Senate confirmed President Obama's appointment of Robert Califf, MD, to head the FDA, despite a vocal opposition and attempt by 4 senators to block confirmation. The opponents argued that the FDA has not exercised enough control over the process of getting new opioid drugs approved.
The "no" votes came from Senators Edward J. Markey (D-Massachusetts), Joe Manchin (D-West Virginia), Richard Blumenthal (D-Connecticut), and Kelly Ayotte (R-New Hampshire). Other opponents to Califf's appointment included activists from law enforcement, public health, and medicine, who are calling for reforms at the FDA to help address the prescription drug and heroin crisis. Sen. Markey's office issued a press release1 and a video of the press conference held February 22, 2016.
Democratic presidential candidate Senator Bernie Sanders (D-Vermont) also had joined the senators opposing Cardiff, according to the medical news website STAT, but Sanders was not among those voting against confirmation.2
"The FDA is supposed to be our nation's pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,"1 said Markey.
"We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers .... The FDA must begin by agreeing to convene advisory committees for all opioid approval decisions, period. We are hemorrhaging lives by the day, and reforming the FDA is the first step needed to staunch the flow of suffering and death,"1 Markey said.
Senator Manchin said, in the press release, "The FDA needs new leadership, new focus and a new culture. Dr. Califf's past involvement with the pharmaceutical industry indicates that he will not be this person. He will not have the impact or leadership capabilities that the nation needs to stem the tide of the opioid crisis. It is for these reasons that I am opposing Dr. Califf's nomination as the FDA Commissioner."1
"As a close observer of FDA's opioid decision-making for many years, I have watched the agency repeatedly put the interests of opioid manufacturers ahead of public health, even in the face of a worsening addiction epidemic,"1 said Andrew Kolodny, MD, an addiction specialist and former president of Physicians for Responsible Opioid Prescribing, and Chief Medical Officer of Phoenix House Foundation.
"The FDA's handling of opioids may be one of the best examples in history of regulatory agency failure leading to a public health catastrophe,"1 Kolodny said.
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