The FDA moved one step closer to approving the first drug marketed to a specific ethnic group yesterday when an agency panel recommended that NitroMed’s BiDil be marketed for strictly treating black people with heart failure.
The drug has  raised questions about how marketing, regulatory and political considerations play a role in new drug development, with critics of NitroMed saying the company has managed the regulatory system and patent law, along with historical inequities to drive its product to market.