Press Release: 2022-01-14

Senator Markey Outlines Opposition to FDA Commissioner Nominee Dr. Robert Califf, Calls for Reforms at FDA to Address Failures That Lead To, Worsened Opioid Epidemic

Senator Markey Outlines Opposition to FDA Commissioner Nominee Dr. Robert Califf, Calls for Reforms at FDA to Address Failures That Lead To, Worsened Opioid Epidemic:

January 13, 2022

Washington (January 13, 2022) – With data showing that the opioid epidemic has only worsened during the COVID-19 pandemic, Senator Edward J. Markey (D-Mass.) today outlined his ongoing concerns with the Food and Drug Administration (FDA) failures to effectively regulate addictive opioids and his opposition to FDA Commissioner nominee Dr. Robert Califf.

In his letter, Senator Markey highlighted how, over 25 years, the FDA repeatedly rubberstamped new prescription opioids that increased the risk of misuse and dependence and failed to limit the broad availability of these drugs, acted too slowly to remove them from the market or place restrictions on their labels, and continued to approve powerful new opioids either over the express objections of its advisory committees or without convening an advisory committee at all. In 2019, the FDA issued a draft guidance on risk assessment for opioid analgesic drugs.  However, Senator Markey notes that the guidance does not explicitly require data on comparative effectiveness and safety of new opioids or discuss consideration of diversion in opioid approvals, nor has the FDA taken further steps either to improve or finalize this critical guidance.

Making the case that stronger regulation of prescription opioids continues to have a role in controlling the epidemic, Senator Markey highlighted several key steps the FDA needs to take in order to show necessary leadership:

  • Undertake a full, comprehensive review of all approved opioids

  • Strengthen the 2019 draft guidance on including public health factors in risk analysis of opioid analgesics by requiring specific data on the comparative effectiveness and safety of the drug

  • Finalize the draft guidance within the next six months, and abstain from approving any new opioid analgesics until this draft guidance is finalized and applied to these drugs

  • Enhance post-market surveillance of opioids, including by conducting regular, formal reviews of opioid approvals

Senator Markey met with FDA Commissioner nominee Dr. Califf in December 2021 to discuss his concerns with the FDA’s efforts to regulate opioids, asking Dr. Califf to make commitments on the draft risk assessment guidance, mandatory prescriber education, and the role of independent advisory committees for opioid approvals. Senator Markey opposed Dr. Califf’s nomination to be FDA Commissioner in 2016.

“During our meeting, Dr. Califf did not commit to the decisive and comprehensive action necessary to ensure reforms that the FDA, under his leadership, would implement on opioid regulation. After years of agency failures and in the midst of a worsening opioid epidemic, we need FDA leadership that is fully committed to utilizing the agency’s full oversight authority to protect public health,” writes Senator Markey in his letter to Acting FDA Commissioner Janet Woodcock. “We continue to live with the consequences of the FDA’s failure to effectively regulate opioids. I remain alarmed that the agency has not done enough to account for or reform its processes for reviewing these supercharged painkillers.”

A copy of Senator Markey’s letter to the FDA can be found HERE.

Senator Markey is a Congressional leader in the effort to combat the opioid crisis. He has passed several pieces of legislation to fund and expand opioid addiction prevention and treatment programs, as well as introduced legislation mandating education on safe prescribing for any prescriber of opioid medication. In 2016, he succeeded in getting the Food and Drug Administration to agree to his request to reassess the way it considers the risks of addiction and misuse when it evaluates the safety of new opioids. In April 2021, Senator Markey led Senators Elizabeth Warren (D-Mass.), Sheldon Whitehouse (D-R.I.), Tammy Baldwin (D-Wisc.), and Cory Booker (D-N.J.) in introducing the Support, Treatment, and Overdose Prevention (STOP) of Fentanyl Act to combat the fentanyl overdose crisis.  He is the author of the Addiction Treatment Access Improvement Act and the Eliminating Opioid-Related Infectious Diseases Act and has also introduced legislation with Senator Mike Braun (R-Ind.), the Lessening Addiction by Enhancing Labeling (LABEL) Opioids Act, which calls for labeling of prescription opioid bottles with a consistent, clear, and concise warning label on the potential of the drugs for dependence, addiction, or overdose.