Petition Calls on FDA to Set Timeline for Designation Appeals Process
A law firm has filed a citizen petition calling on the FDA to reduce delays in the appeals process for drug designations.
In the petition, Epstein Becker & Green notes that under current FDA regulations drugmakers can appeal a designation to the agency’s Associate Commissioner of Special Medical Programs. However, the agency has no set timeline for how soon the associate commissioner must act on those appeals, which has caused significant delays.
The petition calls on the agency to add a subsection to the existing regulations requiring any designation appeals be reviewed within 60 calendar days of submission.