FDA Team Keeps Clients’ Drugs on Market After Threat to End 12-Year Approval

Ed Allera and Barbara Binzak Blumenfeld, Shareholders in the firm’s FDA & Biotechnology group, and Jason Parish, Shareholder in the Litigation group, achieved exceptional success for clients Breckenridge Pharmaceuticals, Inc. and NexGen Pharma, Inc. against the FDA's attempt to rescind their 12-year-old approvals of a generic laxative drug. Ed, Barbara and Jason were assisted by Tina Hu-Rodgers and Alex Gapihan, Associates in the FDA & Biotechnology group, Chance Lyman, Associate in the Litigation section, and Niraj Rath, Associate in the Tax section.

The FDA recently ordered that the approvals of the clients’ generic drugs, approved in 2006, be rescinded. Although the drugs are safe and effective, FDA argued that the same drug cannot be marketed both in prescription and over-the-counter form unless there is a “meaningful difference.” In this case, FDA had concluded that there is no such meaningful difference and the clients’ drugs could not be legally marketed.

As explained in the Law360 article "Drugmakers Assail FDA for Nixing Generic Laxative Approval," "MiraLAX won approval in 1999 as a prescription drug, with generic versions entering the market later. It eventually converted to an over-the-counter drug. The FDA generally doesn’t allow sales of prescription and OTC drugs with the same active ingredients unless they have a ‘meaningful difference’ that requires physician oversight of the prescription drug."

Our team filed a petition for stay with the FDA, arguing that the over-the-counter and prescription versions of the drug are different and that the clients’ prescription drugs shouldn't be withdrawn. They also noted that if the products are no longer available, patients would have to pay retail prices and may end up forgoing treatment, leading to negative health consequences. The team received a six-month stay from the FDA, a rare decision from the Administration, and is preparing to file an appeal to the U.S. District Court of Appeals for the District of Columbia.

Read more in Law360's latest article (Apr. 20): "MiraLAX Generics Get FDA Reprieve Despite Bayer Objections"