US FDA slammed over generic Prilosec delays

US consumer, labor and religious groups are calling on Health and HumanServices Secretary Tommy Thompson to probe actions by the US Food and Drug Administration which they say are delaying approval of generic versions of AstraZeneca's blockbuster acid-regulating drug Prilosec (omeprazole), according to the Gray Panthers consumer coalition.

While AstraZeneca's US patent on Prilosec, the world's top-selling drug, expired October 9, the company will defend its position in a New York court on December 5, after earlier dates for the lawsuit had to be postponed in the wake of the September 11 terrorist attacks in the city. The trial will examine the validity of four patents filed by the company, which it believes should provide patent protection on its product until 2019.

The Gray Panthers have repeated claims made in early October by Andrx, a Florida firm which is the first of several planning to bring generic versions of the drug to market, that AstraZeneca told the FDA that Andrx' drug did not have exactly the same chemical structure as its product. The Panthers say that, while AstraZeneca had said that generic versions of Prilosec might be inferior, it had offered no scientific evidence to support its claim.