Senator Markey Cites Concerns Over Opioid Crisis, Need to Reform FDA in Opposition to Nominee Scott Gottlieb
Gottlieb has expressed opposition towards FDA process for ensuring safe use of opioids and other prescription drugs
Washington (March 15, 2017) – Senator Edward J. Markey (D-Mass.) released the following statement today in opposition to President Donald Trump’s nomination of Scott Gottlieb as Commissioner of the Food and Drug Administration (FDA) and calling for reforms to the agency’s oversight of opioid painkillers, which are fueling a public health epidemic. Specifically, Senator Markey is calling for the FDA’s commitment to convene advisory committees for all opioid-approval questions, to fully and consistently implement its Risk Evaluation and Mitigations Strategies (REMS) for opioid drugs, and to remove the so-called “abuse deterrent” opioid drug Opana ER from the market given recent concerns about the drug’s safety.
“The FDA is our nation’s pharmaceutical gatekeeper, but it has been granting unfettered access to Big Pharma and its addictive opioid painkillers that are killing people across the country,” said Senator Markey. “Unfortunately, Scott Gottlieb’s record shows that he doesn’t support using the tools that the FDA has at its disposal to minimize the risks to public health from the misuse of prescription opioids.
“Scott Gottlieb has supported rushing drugs to market with less safety data. He has publicly stated his opposition to the risk plans known as REMS, which are one of the FDA’s most important tools to immediately address the safety of opioid painkillers and other prescription drugs. Even as tens of thousands die in the opioid epidemic, Scott Gottlieb has questioned the value of DEA’s enforcement efforts intended to prevent prescription opioids from entering the illicit market.
“We need a leader at the FDA who recognizes the dangers of these supercharged opioid painkillers, who will stand up to Big Pharma, and who will reform the FDA to prevent addiction before it takes hold. Unfortunately, Scott Gottlieb’s nomination signals a continuation of the FDA policies that have cultivated and fueled the opioid epidemic, and which Republican efforts to repeal health care and addiction treatment for millions of Americans will only worsen.
“Until Mr. Gottlieb commits to reforming the way the FDA approves and manages prescription opioids, I will vigorously oppose his nomination.”
This week, an FDA advisory committee ruled that the risks of Opana ER, a prescription opioid that has been linked to a 2015 HIV outbreak in Indiana, outweigh the benefits. Opana ER was reformulated to be “abuse-deterrent” to deter abusers from snorting the drug, but it is now being injected, leading to overdoses, blood infections and deaths. Last year, Senator Markey released an analysis of the FDA opioid approval decisions that found that the agency has repeatedly bypassed advisory committees when considering opioids with abuse-deterrent claims. In the report, Senator Markey highlighted Opana ER as a drug approved without the benefit of an FDA advisory committee.