April 5, 2019

President Donald J. Trump
The White House
1600 Pennsylvania Ave NW
Washington, D.C. 20500

Secretary Alex M. Azar II
Department of Health and Human Services
200 Independence Ave SW
Washington, D.C. 20201

Dear President Trump and Secretary Azar,

During this period of leadership transition at the Food and Drug Administration (FDA), we implore you to intervene and urge the Administration to use its full discretion and authority to combat the opioid crisis that is killing 130 Americans every day.

Despite bold statements about their efforts, the FDA is failing to adequately promote recovery and has even taken steps to make it harder to achieve recovery while continuing to flood the market with powerful new opioid painkillers.

For example, in November 2018, the FDA approved a form of sufentanil, the most potent opioid on the market, despite criticism and outrage from advocates, providers and policymakers. The next month, the FDA shelved an innovative recovery treatment, a monthly or weekly depot injection of buprenorphine, despite deeming it “safe and effective.”

Currently, there are eight times more opioid painkillers available to patients than there are recovery medications. When we put this in context of the decisions the FDA has made over the last six months, it’s clearly time to hold the FDA accountable.

The recovery community is very concerned about this lack of transparency and accountability. As you work to help the FDA transition to Acting Commissioner Sharpless and eventually a new FDA commissioner, we urge you to keep recovery in mind and push the FDA to:

  1. Prioritize recovery innovation, including giving survivors access to medications that have already been developed, tested, and approved, and fill gaps in treatment.
  2. Be a better watchdog on opioids by fixing the surveillance system on what happens after opioids are approved.
  3. Be transparent and accountable to the public by telling us who is making decisions and how they are made to ensure that decision makers actually understand medication-assisted treatment and opioid addiction.

Please investigate these decisions and put recovery first when nominating the next FDA Commissioner. We need your leadership to wake up the FDA and ensure the Administration does everything in its power to address this public health emergency.

Sincerely,

Recovery Reform NOW
The Opioid Spoon Project
P.A.I.N.
Team Sharing
The Voices Project

Download the PDF of the letter here.