The imminent approval of Biogen Inc.'s Avonex beta interferon for multiple sclerosis, and the FDA's response to the lawsuit by Berlex Laboratories to block that approval, should serve as a reminder to some - and is probably an eye-opener to others - that the Orphan Drug regulations are built like a sieve.

On its face the law implies that companies receiving Orphan Drug Status have a seven-year monopoly on their compounds. But a reading of the regulations and the court briefs filed by the interested parties in the case - including the FDA as well as Berlex and Biogen - suggests otherwise (see BioCentury April 29, and BioCentury Extra April 30 and May 1).