FDA Withdraws Direct Final Rule on Biologics Inspections

Last week, the FDA announced that it will withdraw a direct final rule that proposed to amend general biologics regulations related to time of inspection requirements and to remove some duties of inspector requirements. In its statement withdrawing the rule, the FDA indicated that it had received significant adverse comments related to its proposal. The agency did not respond to questions from The Center for Biosimilars^® about the nature of the adverse comment or comments that led to withdrawal of the rule.

The FDA had made the decision to issue the rule directly because the agency had believed it included “only noncontroversial amendments,” and the FDA anticipated no significant adverse comments that would affect its plan. The rule was intended to remove what it referred to as “outdated requirements” and to help eliminate inconsistencies and duplicative processes.

“These existing codified requirements are unnecessary because they are duplicative of statutory requirements that apply to biological product inspections under section 704 of the [Food, Drugs, & Cosmetics Act] FD&C Act. Specifically, the inspection requirements in section 704 of the FD&C Act encompass all requirements outlined in §600.22. Thus, we are removing §600.22(a) through (h),” said the agency of its rule.

In the past, the FDA required biennial inspections of drug and biological manufacturing facilities. However, when the Food and Drug Administration Safety and Innovation Act (FDASIA) was introduced in 2012, the biennial inspection requirement was replaced with a risk-based schedule requirement for inspecting manufacturing plants.

“While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase. We’ll continue to inspect facilities at the same standards and enforce the laws and regulations on manufacturing that help protect patients,” stated FDA Commissioner Scott Gottlieb of the rule.