April 22, 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,

Earlier this month, our coalition of concerned advocates sent a letter imploring you to intervene and urge the Food and Drug Administration (FDA) to use its full discretion and authority to combat the opioid crisis that is killing 130 Americans every day. In light of recent news, we now call on you to investigate and act on the FDA’s failure to work in the best interest of Americans in recovery by shirking their oversight responsibilities and thwarting innovation and competition, keeping drug prices high. It’s unconscionable that a powerful agency like the FDA has contributed to this public health emergency, either intentionally or out of incompetence, and is a situation that must be quickly addressed.

Earlier this month, news surfaced that the FDA gave Indivior an orphan drug designation (ODD) for their buprenorphine product 25 years ago and has been using that ODD to give blanket orphan drug status to their newer buprenorphine-based products ever since. With millions living with opioid addiction, how could opioid use disorder possibly be categorized as a rare disease? It is a bastardization of the Orphan Drug Act of 1983. Adding insult to injury, the FDA released industry guidance in February 2019 to encourage development of similar products while knowing that these types of innovations are barricaded from coming to market due to exclusivity clauses that come along with orphan drug designations.

Later that day, the American people learned that the Department of Justice charged Indivior—the same pharmaceutical company that has benefited from an ODD for 25 years— with using misleading and fraudulent marketing practices for one of their newer buprenorphine products.

When it comes to opioid recovery, the FDA is completely failing.

Mr. President and Mr. Secretary, we urge you to investigate the FDA’s role in these situations and take the following actions to wake up the FDA to this public health crisis:

  1. Waive patent exclusivity during this public health emergency to foster innovation.
  2. For every new narcotic pain medication brought to market, require the FDA to offer a new recovery innovation to safely and effectively treat substance use disorder.
  3. Require the FDA to change its drug approval processes to permit expedited consideration of addiction treatment interventions, such as medications, digital therapeutics, and other innovations.
  4. Require scientific and clinical advisors who serve on opioid-related panels to have demonstrated expertise in opioid use disorder – a very different addiction to treat than other addiction disorders.
  5. Forbid the FDA from overruling its own scientific advisory panel on narcotic medication approvals without justifying their reasoning before congressional oversight committees.

The recovery community is disturbed by the lack of oversight that has allowed the FDA to make such egregious missteps, either through incompetence and a lack of coordination or through illicit industry loyalties.

We need your leadership to hold the FDA accountable for its role in these situations and to demand that the FDA develops and adheres to policies and processes that both remedy the situation and prevent them from occurring again.



Recovery Reform NOW
Rhode Island Users Union
The Opioid Spoon Project
Sackler P.A.I.N.
Team Sharing
The Voices Project