Senator Markey outlines opposition to FDA nominee Commissioner Dr. Robert Califf and calls for reforms at the FDA to fix mistakes that are leading to a worsening opioid epidemic

WASHINGTON (January 13, 2022) — With data showing that the opioid epidemic has only gotten worse during the COVID-19 pandemic, Sen. Edward J. Markey (D-Mass.) today outlined his ongoing concerns about food and Drug Administration (FDA). Failure to effectively regulate addictive opioids and his opposition to FDA nominee Commissioner Dr. Robert Califf.

In his letter, Senator Markey highlighted how, for 25 years, the FDA has repeatedly approved new prescription opioids that increase the risk of abuse and addiction, failed to limit the wide availability of these drugs, and acted too slowly to address them removing restrictions on their labels from market or location, and continued to approve powerful new opioids either against the express objections of its advisory committees or without even convening an advisory committee. In 2019, the FDA released draft guidance on risk assessment for opioid analgesics. However, Senator Markey notes that the guidance does not specifically require data on the comparative efficacy and safety of new opioids, nor does it discuss the consideration of diversion in opioid approvals, nor has the FDA taken additional steps to improve or finalize this important guidance.

Senator Markey argued that greater regulation of prescription opioids continues to play a role in controlling the epidemic, and highlighted several important steps the FDA must take to provide the necessary leadership:

  • Conduct a full and comprehensive review of all approved opioids
  • Strengthening of the 2019 draft guidance on the inclusion of public health factors in the risk analysis of opioid analgesics by requiring specific data on the drug’s comparative efficacy and safety
  • Complete the draft guidelines within the next six months and refrain from approving new opioid analgesics until this draft guideline is finalized and applied to those drugs
  • Improve post-market surveillance of opioids, including by conducting regular, formal opioid regulatory reviews

Senator Markey met with Dr. Califf, the FDA commissioner-nominee, to discuss his concerns about FDA efforts to regulate opioids and urged Dr. Califf to make commitments on the draft risk assessment guidelines, mandatory training for prescribers and the role of independent advisory committees for opioid approvals. Senator Markey opposed Dr. Califf’s appointment as FDA Commissioner in 2016.

“During our meeting, Dr. Califf is not committed to the critical and comprehensive actions necessary to secure reforms that the FDA would implement under his leadership on opioid regulation. After years of agency failure and in the midst of a worsening opioid epidemic, we need FDA leadership that is fully committed to using the agency’s full oversight authority to protect public health,” Senator Markey wrote in his letter Acting FDA Commissioner Janet Woodcock. “We continue to live with the consequences of the FDA’s failure to effectively regulate opioids. I remain concerned that the agency has not done enough to address 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 efforts to combat the opioid crisis. He has passed several laws to fund and expand opioid addiction prevention and treatment programs, as well as legislation requiring safe prescribing training for every opioid drug prescriber. In 2016, he managed to get the Food and Drug Administration to agree to his request to reevaluate the way it considers the risks of addiction and abuse when evaluating the safety of new opioids. In April 2021, Sen. Markey led Senators Elizabeth Warren (D-Mass.), Sheldon Whitehouse (DR.I.), Tammy Baldwin (D-Wisc.) and Cory Booker (DN.J.) in introducing the support, treatment , and Fentanyl Act’s Overdose Prevention (STOP) to address the fentanyl overdose crisis. He is an author of the Addiction Treatment Access Improvement Act and the Eliminating Opioid-Related Infectious Diseases Act, and also sponsored legislation with Sen. Mike Braun (R-Ind.), the Lessening Addiction by Enhancing Labeling (LABEL) Opioids Act, which calls for the Labeling of prescription opioid bottles with a consistent, clear and concise warning about the potential for dependency, addiction or overdose of the medication.


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