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FDA pillories drug companies for their noncompetitive shenanigans

By Mari Serebrov, Regulatory Editor

The shaming begins. As promised, the FDA called out drug companies by name today for refusing to play fair.

In the 21st century version of pillorying, the agency posted a list of innovators that have refused to supply would-be competitors with the drug samples necessary to develop generics. In many cases, the innovators used their risk evaluation and mitigation strategies (REMS) with elements to assure safe use as an excuse not to sell generic drug developers the samples needed for bioequivalency studies.

But REMS weren’t to blame for all of the denials. Requests for more than half of the 50 drugs on the list were turned down because of contractual clauses the innovators imposed on distributors, wholesalers or specialty pharmacies that prevented them from selling samples to would-be competitors.

The list shows such shenanigans, as FDA Commissioner Scott Gottlieb has called them, are not limited to outliers in the biopharma industry. They appear to be a common practice among some of the household names in the industry.

The drugs on the list were made by the following companies or their subsidiaries:

  • Acorda Therapeutics Inc.
  • Actelion Pharmaceuticals Ltd.
  • Apotex Inc.
  • Astrazeneca plc
  • Bayer AG
  • Biogen Inc.
  • Biomarin Pharmaceutical Inc.
  • Boehringer Ingelheim GmbH
  • Celgene Corp.
  • Corcept Therapeutics Inc.
  • Cubist Pharmaceuticals Inc.
  • Danco Laboratories LLC
  • Galena Biopharma Inc.
  • Gilead Sciences Inc.
  • Glaxosmithkline plc
  • Heritage Life Sciences (Barbados Inc.)
  • Hikma Pharmaceuticals plc
  • H. Lundbeck A/S
  • Horizon Pharma plc
  • Insys Therapeutics Inc.
  • Jazz Pharmaceuticals plc
  • King Pharmaceuticals Inc.
  • Mallinckrodt plc
  • Meda Pharmaceuticals Inc.
  • Mylan NV
  • Novartis AG
  • Novelion Therapeutics Inc.
  • Orphan Europe Sarl
  • Pfizer Inc.
  • Roche Holding AG
  • Shire plc
  • Sun Pharmaceutical Industries Inc.
  • Swedish Orphan Biovitrum AB
  • Teva Pharmaceutical Industries Ltd.
  • Valeant Pharmaceuticals International Inc.
  • Vivus Inc.