November 22, 2019

DEA's Latest Hit in the Buprenorphine Debate

On October 30, Federal Court for the Southern District of West Virginia dissolved an immediate suspension order ("ISO") issued by DEA. The opinion from the federal court in Oak Hill Hometown Pharmacy c. Uttam Dhillon, et. al. demonstrates DEA's growing concern with single-entity buprenorphine products and, also, the federal courts' demand for DEA to ground enforcement actions regarding such concerns in fact-based evidence documented in the administrative record. In Oak Hill, a small West Virginia pharmacy was found to have filled 2,000 buprenorphine prescriptions across a 2 1/2-year period, some for Suboxone (combination product) but most for Subutex (single-entity product). Without providing the court any evidence of diversion, DEA argued the mere prescription count was an indicator of diversion primarily because Subutex was dispensed where DEA believed Suboxone should have been used. However, the court disagreed and found that, absent evidence of actual diversion, lawfully dispensing one FDA-approved product over another cannot alone be evidence of diversion sufficient to suspend registration.

The judge shared the significance that "Suboxone and Subutex are to be used to treat addiction" and the public interest in making such treatment more widely available supersedes DEA's belief of "what it sees as a suspicious pattern of the filling of lawful prescriptions for medication designed to treat opiate addiction." The court reminded DEA that the "set of controlled substances used medically to treat pain are a far different species of opiate than Suboxone and Subutex­--necessary to treat addiction." And, accordingly, as DEA allocates its resources to fight diversion and abuse, the Court highlighted the fact that "the number of deaths involving sublingual buprenorphine products that are specifically approved by the [FDA] for the indication of opioid dependence treatment from 2002 to October of 2013 totaled 464," which cannot compare to the attention and concern deserving of death rates associated with pain treatment medication.