FDA Admits It Was Wrong to Ax Critic of Lilly's Effient

Last Updated Jul 16, 2009 3:28 PM EDT

The FDA has "formally admitted" that excluding a critic of Eli Lilly's Effient/prasugrel blood-thinner from a panel earlier this year was wrong, according to a press release from Rep. Maurice Hinchey, D-N.Y. The news is the latest headwind in the troubled launch of a drug that is crucial for Lilly. The release says:
The FDA admitted that the decision to remove [Dr. Sanjay] Kaul was made by agency staff that did not have the authority to unilaterally do so.
Kaul was removed from a panel reviewing Lilly's application for Effient after he told Reuters that he believed the bleeding risks for Effient were less clear cut that Lilly claimed. Hinchey said:
The agency does not, however, refute Hinchey's argument that the decision was made after FDA officials consulted with Eli Lilly representatives.
Hinchey's site does not provide the FDA letter itself, making it difficult to judge what it actually says.

This is the latest in a string of bad news for Lilly and Effient. The drug was approved with a black box warning last week; analysts curbed their estimates of its peak sales due to the price premium Lilly put on the drug.

The FDA "admission" is another cloud hanging over Effient. In addition to Lilly's maneuvering to ax Kaul from the panel, one of the docs involved in the drug's development wrote a letter urging that it not be approved until a "properly designed" phase 3 trial had been completed.