§ Mr. Martyn JonesTo ask the Secretary of State for Health what information he has on guidance issued by the United States Food and Drugs Administration to doctors on the recommended dosage of the anti-AIDS drug Retrovir (AZT); and whether he has any plans to issue guidance to doctors in the United Kingdom.
§ Mrs. Virginia BottomleyWe are aware of reports indicating that the United States Food and Drug Administration has recently announced labelling changes for Retrovir involving a lowering of the recommended daily dose approved for administration in that country. Any changes to the licensed indication of drugs marketed in the United Kingdom must be approved by the licensing authority on grounds of safety, quality and efficacy seeking, where necessary, the advice of the Committee on Safety of Medicines. Doctors already have extensive information on the currently licensed product from a wide variety of sources, and we have no plans at present to issue further guidance.