FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Woodcock, AAM Testify on REMS Programs Delaying Generic Competition

March 29, 2017

The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing.

Access to drugs can be denied through REMS, contracts or self-imposed restrictions. Certain brand pharmaceuticals have used restricted distribution schemes to block purchases and testing, so generic drugs and biosimilars cannot be developed.

 “Having worked in the biotechnology industry for over 25 years and in the biosimilars industry since its inception, I’ve seen firsthand how these strategies prevent or delay competition,” said Bruce Leichner, a senior vice president at Momenta Pharmaceuticals and board chair of the AAM’s Biosimilars Council, in testimony before the health care panel of the House Oversight and Government Reform Committee.

In the past few years, when Momenta sought to purchase brand products from wholesalers in the supply chain, “we are now asked if we are conducting generic or biosimilar studies. On multiple occasions, they inform us that their contract prohibits them from selling the brand product for that purpose. No REMS program was involved; it was simply a self-justified refusal to sell to a generic or biosimilar competitor,” he said.

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