Can FDA initiate a switch on its own?
There is only one historical example of FDA attempting the switch of a prescription drug to OTC status on its own initiative. In 1982, FDA issued a tentative final monograph which included metaproterenol for asthma. Due to a hailstorm of negative comments, the agency rescinded its decision shortly thereafter.Theoretically, FDA could make a recommendation to switch a product; however, the agency would need to follow a resource-intensive, complex process. There are unresolved and debated questions concerning such an approach, including the use of proprietary data, formal hearing rights, under what authority FDA would seek to do so, and the lack of regulations.
There is only one historical example of FDA attempting the switch of a prescription drug to OTC status on its own initiative. In 1982, FDA issued a tentative final monograph which included metaproterenol for asthma. Due to a hailstorm of negative comments, the agency rescinded its decision shortly thereafter. Theoretically, FDA could make a recommendation to switch a product; however, the agency would need to follow a resource-intensive, complex process. There are unresolved and debated questions concerning such an approach, including the use of proprietary data, formal hearing rights, under what authority FDA would seek to do so, and the lack of regulations.
