McConnell Urges FDA Nominee to Address Prescription Opioid Epidemic

‘I had a productive meeting with Dr. Califf this afternoon, and will be reviewing the details of FDA’s proposal carefully.’

WASHINGTON, D.C. – U.S Senate Republican Leader Mitch McConnell met today with Dr. Robert Califf, the nominee for Commissioner of the Food and Drug Administration (FDA), to discuss the agency’s proposal to address the prescription opioid epidemic in Kentucky and our nation.

The FDA plays a leading role in addressing the prescription opioid epidemic through their drug approval process, where they are required by federal law to ensure that drugs are safe and effective. However, FDA has been criticized for not recognizing the severity of this epidemic and not taking steps to do more to address the problem.

During the meeting, Senator McConnell expressed concerns to Dr. Califf that he has heard from Kentuckians regarding FDA’s lax attitude toward this epidemic, and he urged Dr. Califf to commit to taking concrete steps to address the severity of the problem.

“Drug overdoses, largely driven by prescription painkillers, continue to outpace the number of fatalities from traffic accidents in Kentucky,” Senator McConnell said. “While I recognize the need to protect legitimate patient access to prescription painkillers, FDA must do better to protect our friends and families from unwanted dependence and addiction to prescription opioids. I had a productive meeting with Dr. Califf this afternoon, and will be reviewing the details of FDA’s proposal carefully.”

Senator McConnell and FDA Commissioner Nominee Califf meet in Washington, D.C.

NOTE: In 2012 and 2013, Senator McConnell sent letters to the FDA expressing concerns with generic, crushable opioids coming to market without abuse-deterrent features. As a result, in April 2013, FDA announced its decision to prohibit a generic version of a certain opioid without abuse-deterrent features from coming to market.

Last year, Senator McConnell also worked to enact and pass the bipartisan Protecting Our Infants Act, which requires a comprehensive strategy to be set in place to address the rise in prenatal opioid addiction and the infants born dependent on opioids as a result of this addiction.

And in October, 2015, Senator McConnell joined more than twenty Republicans in the Senate and House in sending a letter to OMB Administrator Howard Shelanski urging him to exercise his leadership and commitment to addressing the prescription drug abuse epidemic by ensuring manufacturers would not be disincentivized from developing abuse-deterrent formulations, which make opioids harder to crush and abuse, by having to pay additional Medicaid rebates.

Related Issues: Opioid Abuse, Nominations