Court Reverses Pill Ruling In Germany

Akzo Nobel and Schering AG have been victorious in their bid to overturnthe restrictions on certain third-generation oral contraceptive products in Germany. The announcement follows months of debate over whether the third-generation products were associated with a higher risk of venous thrombosis than the earlier second-generation products (Marketletters passim).

The controversy began in October 1995 when the UK Department of Health issued a warning about seven brands of combined contraceptive pill, citing new evidence from three studies which it said showed that these products carry twice the risk of causing thrombosis than other, older brands. The German health regulatory authority, the BfArM, declared in December 1995 that third-generation pills should not be prescribed to first-time users who were under the age of 30.

In its ruling, the court said that the BfArM had restricted the drugs "on pure speculation without scientific basis," according to Akzo Nobel.