USA – NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses

Congressional action is necessary stop pharmaceutical companies from abusing the Orphan Drug Act, filing sham citizen petitions and extending the market exclusivity for products that are reformulated, Rebecca Haffajee, assistant professor of health management and policy at the University of Michigan, and Richard Frank, professor of health economics at Harvard Medical School, write in a New England Journal of Medicine perspective.

Haffajee and Frank offer the example of Reckitt Benckiser’s Suboxone, a patent-protected buprenorphine-naloxone sublingual film, which has seen limited competition because the firm exploited various US Food and Drug Administration (FDA) regulatory procedures.

They explain how Reckitt, which is now operating as Indivior, earned at least $1 billion in extra profits by securing orphan drug status for its buprenorphine products (although that orphan status is in the process of being revoked by FDA), manipulated the availability of such products, filed questionable citizen petitions and abused FDA’s Risk Evaluation and Mitigation Strategy (REMS) plan by not working with generic manufacturers.

The company also “product hopped” from its tablet formulations to its new film formulation, which involved raising the tablet prices and then removing them from the market…