WASHINGTON – Senator Maggie Hassan (D-NH), a member of the Health, Education, Labor, and Pension Committee (HELP), and Senator Ed Markey (D-MA) sent a letter yesterday to the U.S. Food and Drug Administration’s (FDA) Commissioner, Scott Gottlieb, M.D., calling for a fuller accounting of the FDA’s past decision-making processes for the approval and labeling of opioid drugs.


The letter was sent in response to a statement released by Commissioner Gottlieb after a recent 60 Minutes report entitled, “Did the FDA Ignite the Opioid Epidemic?


In their letter to Commissioner Gottlieb the Senators wrote, “You have said that the FDA made mistakes regarding the opioid crisis and have pledged to learn from these mistakes. The FDA must provide a fuller accounting of its past decision-making processes for the approval and labeling of opioid drugs, including the influence that pharmaceutical executives had on these decisions.”


“While some of these issues concern decisions and actions that the FDA took decades ago, getting answers to these questions is vital to ensure that current opioid labels protect public health and safety, and to prevent the FDA from repeating its past mistakes in the approval of new opioid products,” the Senators added. “Throughout your tenure as FDA Commissioner, you have spoken repeatedly about the gravity of the opioid crisis, and we respectfully request that you answer the following questions in writing before your time at the agency concludes.”


The questions seek more information on a range of topics including the FDA’s 1995 approval of OxyContin and the 2001 change to the OxyContin label; what actions the FDA has taken to implement the Strategies for Reducing the Opioid Epidemic released by the National Academies of Sciences, Engineering, and Medicine in 2017; the status of previous post-market studies for opioid products that the FDA has said it would require; and the controversial Enriched Enrollment Randomized Withdrawal (EERW) clinical trial methodology that the FDA allows for opioid products.


The letter can be read in full here.