Shutdown nixes Merck's FDA panel date, spares other drugs
While the plodding government shutdown has thus far left the biotech industry largely unmarred, the furlough-weakened FDA has now postponed an advisory committee hearing, leaving Merck ($MRK) and Stallergenes in limbo with their allergy drugs.
The agency's Allergenic Products Advisory Committee was set to discuss Merck's Grastek and Stallergenes' Oralair on Nov. 5 and 6, but thanks to mandatory layoffs that have roughly halved the agency's workforce, that meeting is postponed indefinitely, the companies said.
Despite the now week-old shutdown, the FDA is still planning to make good on its October panel meetings, and the November postponement has nothing to do with dwindling resources or under-staffing but is instead a matter of agency policy.
October's meetings all cover new pharmaceutical products and medical devices and are, as a result, supported by industry fees collected in advance. New allergenic products, however, are not part of the FDA's user fee agreement, and thus their attendant panels will have to wait until there's a functional government to pick up the bill, an FDA spokesman told FierceBiotech.
So, while the postponement may lead to headaches for Merck and Stallergenes, it's not the harbinger of more shutdown-prompted approval delays many assumed, and already-paid applications are still expected to come through on time, as Pfizer ($PFE) and Ligand ($LGND) found out last week.
That said, if Congress' impasse drags on long enough, there will come a point when all of the user-fee-funded work is over, and, because the FDA can't collect new fees, drug reviews will come to a halt. The agency has already had to cease accepting drug, biologic and device submissions that weren't paid for pre-shutdown.
Both Grastek, developed by Merck and partner ALK, and Oralair are biologics targeting grass pollen allergies. The companies said they'd heard nothing about a new panel date from FDA, and, considering the agency's response, it's unlikely they will until there's a resolution to fund the federal government.