While the US Food and Drug Administration (FDA) made it a point this week to indicate that it's trying its best to ensure that disruptions to the review of already-submitted drugs under its prescription drug user fee program are minimized during the ongoing government shutdown, at least one company has announced that its planned advisory committee is being postponed due to the shutdown.
FDA has publicly maintained that "generally, scheduled advisory committee meetings regarding the approval of, or postmarketing safety issues regarding, products within the scope of the [user fee programs] programs may go forward during the lapse period, subject to constraints on resources and travel. Other advisory committee meetings that can be conducted with carryover user fee balances will be handled on a case-by-case basis."
However, "generally" does not mean "definitely," as one company has found out.
In a statement released on 8 October 2013, ALK-Abelló A/S, a manufacturer of allergy products, said FDA had notified it and its partner Merck that an advisory committee meeting that had been scheduled to meet on 6 November 2013 to discuss its product would need to be postponed "due to the US government shutdown."
The company's product, an investigational grass allergy immunotherapy (AIT) tablet named Grastek, was submitted to FDA through a biologics license application (BLA) in January 2013 and was set to go before FDA's Allergenic Products Advisory Committee. Grastek is already marketed in the EU under the trade name Grazax.
The postponement of a meeting set to take place almost a month from now raises questions about the effects of the shutdown within FDA. While several advisory committee meetings are definitely taking place (including two this week for medical devices), those meetings could have benefited from the bulk of FDA's review work for those applications already being completed.
Edit: As Donna Young of SCRIP Regulatory Affairs informs us, allergenic extract products--of which Grastek is one--is not coveredunder the PDUFA program's user fees, likely explaining the cancellation. We're still waiting to hear from FDA.
Applications that are further away could, by contrast, be under strain during the shutdown, suffering from fewer review resources being available.
Alternately, FDA could be anticipating running out of so-called "carryover" funds from the prior 2013 authorization of the Prescription Drug User Fee Act, which are now funding the agency's reviews during the shutdown. Those funds could run out before a new budget is passed, placing on hold all of FDA's review activities now being funded by carryover fees. If that were to happen, it would likely have a cascading effect on other advisory committee reviews in the future, delaying them by weeks or even months.
FDA has 10 advisory committees scheduled between 8 October 2013 and the original date of the now-postponed advisory committee date for ALK's drug, 5 November 2013.
Focus has reached out to FDA for comment on the postponement, but did not hear back by the time of press. [Editor's note: The shutdown has also furloughed nearly all staff in FDA's office of media affairs, so it's difficult to confirm anything this week.]
No new date for ALK's advisory committee meeting has yet been set.