FDA Issues Direct Final Rule on Biologics Inspections

Samantha DiGrande

This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes.

This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes. Specifically, the rule addresses how frequently the FDA inspects some facilities, and the listed duties of the inspector.

In the past, the FDA required biennial inspections of drug and biological manufacturing facilities. However, with the introduction of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012, the biennial inspection requirement was replaced with a requirement for the FDA to inspect manufacturing plants on a risk-based schedule.

The direct final rule aligns with the FDASIA framework, accommodates the risk-based framework, and clarifies the FDA’s flexibility under FDASIA to inspect facilities either more or less frequently as appropriate.

“Biologics are at the forefront of some of the most significant medical advances of the 21 century, but many are also complicated to manufacture. 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,” said said FDA Commissioner, Scott Gottlieb, MD, in a statement.

“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,” Gottlieb added.

In addition to clarifying the frequency of inspection of manufacturing plants, the rule also removes outdated “duties of inspector” requirements. The FDA has deemed that it was unnecessary to list these obligations in the document because those duties are duplicated in the Federal Food Drug and Cosmetic Act (FFDCA). The removal of these regulations, however, does not change the inspection requirements, nor does it amend the actual duties of an investigator.

The final rule applies to all licensed biological products. The FDA hopes that this change will clarify its flexibility to prioritize its inspection resources to higher-risk facilities, such as those involved in the manufacturing of products that raise potentially significant safety concerns.