- FDA published a direct final rule Thursday to alter what it calls outdated regulations on biologic inspections. The old requirements mandated facilities be inspected at least once within 2 years of being registered, and then at least once every two years afterward.
- Pointing to the 2012 FDA Safety and Innovation Act, the agency noted it is now required to inspect drug establishments on a risk-based schedule.
- "The new regulations reflect the FDA's flexibility to prioritize its inspectional resources to higher-risk facilities, such as those that produce vaccines or gene therapies, and those that have complex manufacturing steps and must be more closely monitored due to the potential for more risk. While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase," FDA Commissioner Scott Gottlieb said in a statement.
The agency issued a direct final rule on the belief that the changes are "noncontroversial and FDA anticipates no significant adverse comments." Comments are being accepted until April 11, and the rule is set to go into effect June 11.
The rule also removes certain inspector requirements, which FDA says are duplicative of statutory requirements already in the Federal Food, Drug, and Cosmetic Act.
"The removal of these regulations does not change the establishment inspection requirements and duties of an investigator specified in the statutes, the procedures described in the FDA Investigations Operations Manual and other FDA manuals and guides," FDA said.
The action comes as FDA moves to reduce regulation to speed drug approvals.
FDA says the move will help implement its regenerative medicine framework and aligns with its overall shift to a risk-based enforcement strategy.