S.T.E.P.S. FDA and Post-Marketing MonitoringIntroduction

Thalidomid (Thalidomide) will be sold as a 50 mg. oral capsule. Its undisputed teratogenicity led to the formulation of STEPS, an acronym for regulations called System for Thalidomide Education and Safety Program which requires a series of steps be implemented before Thalidomide is dispensed (see Table). To what degree STEPS will be effective remains to be seen. Calgene Inc., holds exclusive Thalidomide marketing rights in the U.S. and will send mailings to physicians and pharmacies (none were received by our facilities).

In developing countries, where regulation of access to teratogenic drugs is more difficult and where self-administration of drugs is more common, many fear that Thalidomide induced birth defects may occur in significant numbers. Thalidomide is already regarded as a therapeutic agent that offers new hopes for those with a broad spectrum of relatively common ailments.

STEPS requires: Pregnancy testing Birth control use Physician education Mandatory patient education Registration Patient informed consent forms