(Washington, DC) The Attorney General for the District of Columbia, Linda Singer, announced today that the District and 26 states have reached a settlement with pharmaceutical manufacturer Purdue Pharma regarding OxyContin, a narcotic used for management of continuing, moderate-to-severe pain. The settlement resolves allegations that Purdue Pharma failed to adequately disclose to the public that the drug posed an unusually high risk of abuse, and that the company engaged in extensive marketing of OxyContin for other, “off-label” uses.
While physicians may in individual cases exercise their professional judgment to prescribe an off-label use to treat a specific problem, the Food and Drug Administration does not allow pharmaceutical manufacturers to affirmatively market their drugs for such uses because the overall safety and effectiveness for such uses have not been established by extensive, thorough clinical testing.
The District’s settlement will be filed as a Consent Judgment in DC Superior Court. The judgment’s injunctive provisions impose restrictions on how OxyContin is marketed. It also requires Purdue Pharma to maintain an abuse and diversion-detection program to detect and report problem prescribing, and requires all field sales personnel to undergo program training before being allowed to sell OxyContin.
“Inappropriate marketing of drugs for uses not approved by the FDA is serious and can lead to overuse and abuse of what otherwise would be a safe and effective product. The agreement reached today will help stem the continuing illicit use of OxyContin,” said General Singer. “I commend Purdue Pharma on its cooperation and willingness to work with the attorneys general to resolve the issues arising from its marketing of this widely abused drug.”