McConnell Says Confirming FDA Nominee First Step to Ensure Agency Takes Greater Action to Address Opioid Epidemic

WASHINGTON, D.C.U.S. Senate Majority Leader Mitch McConnell made the following statement today regarding the Senate vote to proceed to confirmation of Robert Califf to be the Commissioner of the Food and Drug Administration (FDA):

“Drug overdose deaths, driven largely by prescription painkillers, continue to outpace the number of fatalities from traffic accidents in Kentucky. While I recognize the need to protect legitimate patient access to prescription painkillers, the FDA must do more to help us fight back in the midst of today’s prescription-opioid epidemic.

“The FDA plays a leading role in addressing this epidemic through its drug-approval process, in which it is required by federal law to ensure the safety and effectiveness of all drugs. However, the FDA has been rightly criticized for not recognizing the severity of this significant problem and for not taking greater action to address it.

“Over the years, I’ve heard from many Kentuckians concerned about FDA’s lax attitude in this area, with many of the belief that the agency simply has not taken its role in fighting the prescription opioid epidemic seriously.

“To try and push the FDA in the right direction, I contacted the agency in both 2012 and 2013 to warn of the problems with allowing generic, crushable opioids to be made available without the introduction of abuse-deterrent features. As a result, the FDA announced in April 2013 that it had decided to prohibit a generic version of a certain opioid that lacked abuse-deterrent features.

“I also co-sponsored a measure in the last Congress that aimed to push the FDA to encourage the development and use of abuse-deterrent formulations of prescription opioids, which make them harder to crush and abuse.

“Additionally, I joined more than 20 Senate and House members last October in a letter to OMB’s Administrator of Information and Regulatory Affairs, Howard Shelanski. We urged him to help us tackle the prescription-drug abuse epidemic by taking down barriers in the Medicaid repayment system that actually discourage manufacturers from developing the very same abuse-deterrent formulations that I’ve been pushing the FDA to encourage.

“I recently met with Dr. Robert Califf, the FDA Commissioner nominee we’ll consider this evening. We had a productive meeting in which I expressed my concerns about the agency’s past insensitivity to the opioid crisis, along with my desire to see the FDA play a more prominent role in addressing this prescription-opioid epidemic. Dr. Califf shared his proposed plan to reassess the agency’s approach to approving and regulating prescription painkillers. Dr. Califf also acknowledged that a cultural shift will be needed within the FDA if the potential for addiction and abuse of prescription opioids is to be taken more seriously. He assured me that as head of this important agency, he would be the kind of leader our country needs when it comes to confronting this growing epidemic.

“I believe Dr. Califf understands the dire nature of the opioid epidemic and, accordingly, I believe he is today the right person to lead the FDA in a new direction. That said, confirming Dr. Califf will be just the beginning of a much longer and enduring effort on everyone’s part; he and the FDA should expect continued rigorous oversight in the way the agency deals with prescription opioids moving forward.”

Related Issues: Opioid Abuse, Nominations