Patrick J. Kennedy Submits Letter in Support of Citizen Petition Requesting FDA to Revoke Orphan Drug Designation for Sublocade to Treat Opioid Use Disorder

Contents of letter displayed below.

June 27, 2019

Division of Documents Management
Department of Health and Human Services
Food and Drug Administration
5630 Fishers Lane
Room 1061

Rockville, MD 20852

RE: Citizen Petition Requesting the Food and Drug Administration (FDA) to Revoke Orphan Drug Designation for Sublocade (Buprenorphine Extended-Release) Injection for Treatment of Opiate Addiction in Opiate Users

To Whom It May Concern:

As lead author of the Mental Health Parity and Addiction Equity Act of 2008 (Federal Parity Law) and a former member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, I am writing today to support the citizen petition to revoke orphan drug designation status for Sublocade.

Opioid Use Disorder (OUD) affects at least 2,000,000 Americans and is not an orphan disease. Sublocade does not meet the criteria of the Orphan Drug Act. In fact, the manufacturer of Sublocade has made clear statements that the product is expected to be highly profitable. It is my strong belief that the FDA must not grant a financial reward meant for a true orphan disease, to a drug to treat OUD. 

Instead, the FDA should align with the goal of the White House—to take an “all-of-government approach” to the opioid epidemic, using “an extraordinary range” of actions—and revoke orphan designation for Sublocade.

Allowing a company to evergreen an orphan designation for 20 years goes against the intent of the Orphan Drug Act. Not only will orphan drug exclusivity for Sublocade discourage competition and lead to higher prices, it will prolong our public health crisis of opioid addiction. Patients need access to more OUD medications, not fewer. Treatment is not one-size-fits all. Providers need options, as not all patients respond to medications in the same way. 

Skyrocketing rates of overdoses and suicides continue to devastate families nationwide. U.S. life expectancy continues to decrease due to these deaths of despair. How much worse does it have to get before we open our eyes and prioritize practical measures to save lives? Orphan designation for Sublocade is unacceptable.


Patrick J. Kennedy
Former U.S. Representative (D-RI)