12:00 AM
Jul 28, 2008
 |  BioCentury  |  Regulation

Conflicting interests

A delayed decision on Ovation Pharmaceuticals Inc.'s NDAs for Sabril vigabatrin demonstrates how pressures to fence out scientists with relationships to industry are increasing the uncertainty of FDA's review processes.

Conflict of interest issues led FDA to postpone a Peripheral and Central Nervous System Drugs Advisory Committee meeting that was scheduled for Aug. 6-7 to discuss two NDAs for Sabril to treat refractory complex partial seizures in adults and for infantile spasms.

The agency already had informed Ovation last month that it would miss the June 30 PDUFA date for the NDAs, according to Office of New Drugs Director John Jenkins and company spokesperson Sally Benjamin Young. FDA does not have a new date for the meeting and will not act on the NDAs in the absence of a committee recommendation, Jenkins said.

FDA could not identify epilepsy experts who met the agency's COI criteria and were available on the planned meeting dates, Jenkins told BioCentury.

The committee has one standing member who specializes in treating epilepsy: Gregory Holmes, section chief of neurology at the Dartmouth-Hitchcock Medical Center.

Holmes has served as a principle investigator in clinical trials of epilepsy drugs that would compete with Sabril in the adult indication. FDA hasn't stated whether he was slated to participate in the Sabril meeting or whether he was recused because of COI.

With or without Holmes, the committee would need to be supplemented with experts, especially in pediatric epilepsy.

“A couple of weeks before the meeting, we realized that conflict of interest [reviews] had kicked out all the epilepsy experts. Either they weren't available because their schedule didn't match up with the meeting, or they were recused for conflict of interest,” Jenkins said.

“We faced the question of do we go to the committee and get advice on an epilepsy drug where no members have expertise in the area, or delay the meeting,” he said. “The...

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