FTC-approved monitor will keep an eye on Endo’s pay-for-delay case

To ensure Endo Pharamaceuticals is abiding by antitrust regulations, the Federal Trade Commission has approved the appointment of an independent monitor in a case alleging the drugmaker paid to block lower-cost generic competitors.

Quantic Regulatory Services has been tapped to evaluate whether Endo’s supply agreements comply with federal orders that bar the company from making anticompetitive patent settlements to block consumers’ access to lower-cost generic versions of Opana ER and Lidoderm.

The FTC filed a lawsuit against Endo last March claiming the company paid generic drug developers Watson Laboratories more than $250 million and Impax Laboratories more than $112 million to not to market authorized generic versions of their drugs. Endo disputed the claims.

Opana is an extended-release opioid used to relieve moderate to severe pain. Lidoderm is a topical patch used to relieve pain associated with post-herpetic neuralgia, a complication of shingles.

The Food and Drug Administration asked Endo on June 8 to stop sales of Opana because the drug’s risks outweighed the benefits, regulators said. The opioid pain medication was being dissolved and injected, leading to an outbreak of HIV and hepatitis C. Endo removed the drug from market on July 6.