To: Anthony Wong who wrote (6434 ) 12/7/1998 8:16:00 AM From: BigKNY3 Read Replies (1) | Respond to of 9523
Internet subverts European drug regulation John McConnell 11/21/98 The Lancet Page 1690 Sex and health-the two most popular subjects for internet browsing-created an irresistible force for change in European druglicensing policy earlier this year when combined in the shape of sildenafil (Viagra). At a Drugs and Therapeutics Bulletin meeting on the challenge posed by the increasing availability of drug information on the internet (London, Nov 11), Miranda Kavanagh (Pfizer, Sandwich, UK) said that in the period between March 27, 1998, when sildenafil gained a US licence, and Sept 15, 1998, when European marketing approval was given, everyone seemed to have a voice on the drug except Pfizer, the manufacturers. In this period, regulation prevented Pfizer giving information about sildenafil on its UK website, yet a search of the internet showed 2000 "unofficial" websites and 140 000 web pages dealing with the drug. The pressure for "official" information led the European Medicines Evaluation Agency to take the unprecedented step of releasing draft patient information before sildenafil was licensed in Europe. Of course, it is not just drug information that is freely available: the drugs themselves can be bought on the internet by mail order without prescription. John Howard, a general practitioner from Caterham, UK, asked what advice-if any-on drug use doctors should give to patients who have bought prescription medicines on the internet? Kavanagh emphasised that her company does not approve or support selling of drugs on the internet, although in her opinion manufacturers were not responsible for the supply of drugs once they had passed to wholesalers. The internet seems then to be making a mockery of European law on the promotion and supply of drugs. Indeed, delegates at the meeting could not even agree whether the law receiving country. What is beyond dispute is that the internet will force the pace on global harmonisation of drug laws. applicable to internet transactions was that of the originating or