The US Food and Drug Administration (FDA) has announced new regulations
and internal reforms to streamline the approval of generic drugs.
The new rules limit drug companies to a single 30-month "stay" of a
generic's entry into the market for resolution of a patent challenge. According
to a 2002 Federal Trade Commission report, in at least six cases, pharmaceutical
companies have blocked the development of generic equivalents of fast-selling
drugs by pursuing multiple 30-month stays.
Vastag B. Medical Illustrations on Display. JAMA. 2003;290(3):324. doi:10.1001/jama.290.3.324-a