Markey: Until There is Reform At FDA, the Opioid Addiction and Overdose Crisis Will Continue

Senator led effort with Senator Manchin in opposition to nomination of Dr. Robert Califf to head agency

Washington (February 24, 2016) – Senator Edward J. Markey (D-Mass.) released the following statement today after voting against the nomination of Dr. Robert Califf to head the Food and Drug Administration (FDA), the agency responsible for the safety of all prescription drugs in the United States. Last month, Senator Markey placed a hold on the nomination of Dr. Califf, calling for the agency’s commitment to convene advisory committees for any future opioid-approval questions and to rescind the approval of OxyContin for kids and convene an advisory panel to provide direction as it reconsiders that decision. As a result of the pressure from Senator Markey, in its recent “Opioid Action Plan,” the FDA announced that it would only convene advisory committees for opioids that are not abuse-deterrent. But an analysis by Senator Markey found that of eleven opioids with abuse-deterrent properties that the FDA has approved since 2010, the agency convened advisory committees for only four of them. In many cases, the FDA approved so-called abuse-deterrent opioids despite warnings from the medical community about the potential for abuse and addiction.

“We will not solve the prescription drug crisis with an FDA that operates with business as usual and continues to turns its back on external experts. The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive opioid painkillers without limits, without supervision and without consequence. The FDA needs to welcome outside expert advice and must convene expert advisory committees for all opioid approval decisions.

“As the Senate prepares to debate comprehensive substance abuse legislation, I am committed to strengthening the bill so that it puts in place real protection for the American people. That includes mandating education for anyone who prescribes opioid painkillers, expanding access to lifesaving medication-assisted therapies, and holding Big Pharma accountable for the consequences of opioid painkiller addiction.

“Prescription drug and heroin addiction is a crisis the likes of which we have never seen in America. A decade from now, we will all be asked what did we do to help end this epidemic. That’s why I voted no on Dr. Califf’s nomination and why I will continue to stand up and fight for the solutions to end this scourge.”

 

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