FDA may allow more conditional drug approvals
Posted Oct. 15, 2014
Federal drug authorities are considering expanding the number of drugs that can receive conditional approvals, a designation for drugs sold while still undergoing effectiveness testing.
The Food and Drug Administration can issue conditional approvals for animal drugs intended to provide treatments for small populations of animals. These include species with small U.S. populations as well as species with large U.S. populations but small portions that would use the drugs, such as those with rare diseases.
The FDA is, through March 9, 2015, accepting comments as the agency considers allowing conditional approvals of more types of animal drugs. An announcement from September does not specify what types of drugs are under consideration.
Drugs with conditional approval have not been subjected to the same effectiveness testing as drugs with full approval, requiring only a reasonable expectation of effectiveness rather than substantial evidence of effectiveness. The drug makers have five years to provide that substantial evidence and receive a drug approval.
The agency also announced in September that it is giving veterinarians guidance on use of drugs with conditional approvals. An FDA Center for Veterinary Medicine spokeswoman said the guidance is intended to inform veterinarians about restrictions on administration of the drugs, particularly prohibitions against extralabel administration, as well as educate them that conditional approval is a path toward selling drugs for some types of treatments.
Those interested in reading or commenting on the FDA’s proposed expansion of conditional approvals can do so here. The FDA guidance, “Conditional approval explained: a resource for veterinarians,” is available here.