Earlier this year the FDA Director of the Office of New Drugs John Jenkins indicated that the agency would have a decreased ability to meet PDUFA dates, saying that the agency was short-staffed. Congress has also been investigating the use of accelerated approval and priority review. Combined, these among other factors, have created a chilling effect on the approval of new drugs. Dr. Jenkins noted that the manufacturer of any product that would experience a delayed approval date would be notified.
On Friday, such a notification went out – to GlaxoSmithKline. The company announced that their priority review application for Promacta® (eltrombopag) for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura has had its PDUFA date extended by the FDA until September 19, 2008 – which now makes it kind of a non-priority review. The Oncology Drugs Advisory Committee voted unanimously (16-0) on May 30 to recommend approval.
This is perhaps a troubling signal for the year, but should also remind investors, analysts, companies and patients that PDUFA are not carved in stone and that advisory committee votes that are unanimous don’t necessarily signal an effortless review process.