FDA slammed over Rx "applesauce" data

The US Stop Patient Abuse Now coalition is demanding an investigationinto what it says are moves by the Food and Drug Administration to protect AstraZeneca's ulcer drug Prilosec (omeprazole) from generic competition (see also page 21) .

SPAN's latest move in its campaign against what it sees as attempts by drugmakers and the agency to prevent generic competition (Marketletter November 12) concerns FDA approval of data supplied by AstraZeneca on use of Prilosec with applesauce. SPAN asks how the FDA could use this data nearly three weeks after the drug's US patent expired, and adds that companies are increasingly using the "applesauce" test to stop generic approvals. For example, it notes, Biovail has submitted its own claim about applesauce to prevent generic competition to its heart drug Tiazac (dialtiazem).

"There are legitimate questions to be raised about who is running the show at the FDA, and whether the FDA is simply allowing AstraZeneca to keep the door open to list new patents," says SPAN founder Tim Fuller. The FDA and Health and Human Services Secretary Tommy Thompson "have a lot of explaining to do," he adds.