Does FDA have the authority to create a third class of drugs?
No. FDA lacks the legal authority to create such a class and, as policy, has repeatedly rejected a third class or transition class of drugs. In September 1999, for example, FDA commissioner Dr. Jane Henney stated: “Weighing the balance, we do not believe that the creation of another class of drugs is needed since there is a formal process in place to establish when a prescription product is appropriate for OTC use.” Additional statements by the agency have repeatedly stated that a public health need for a pharmacy or pharmacist-only class of medicines has not been demonstrated.
