FDAnews
www.fdanews.com/articles/82795-brazil-to-act-on-recreational-ed-drug-use

BRAZIL TO ACT ON 'RECREATIONAL' ED DRUG USE

December 1, 2005

As Brazil acts to tighten regulations on drug promotional material, national regulator Anvisa has banned material promoting a new erectile dysfunction (ED) product launched by local firm Medley. The three leading impotence therapies on the market are also subject to similar tough restrictions, which limit the distribution of promotional material only to prescribers.

Local medical sources justify the restrictions on the grounds that some ED products are potentially dangerous when used in combination with some drugs for circulatory disorders. Meanwhile, Brazil's US$120mn ED market has soared in recent years, with per capita consumption approaching levels comparable with the US, despite the population's lower overall spending power.