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  1. FDA In Brief

FDA In Brief: FDA issues new rule to improve efficiency, effectiveness of oversight over biologics manufacturing

For Immediate Release: Jan. 25, 2018

Media Inquiries

  Andrea Fischer
  301-796-0393

"We’re actively working to modernize our regulations to remove inefficient policies that can add to costs and reduce access without improving safety. As part of this effort, we’ve updated the agency’s inspection requirements for biological products to eliminate outdated provisions, and provide flexibility for the FDA to take a more risk based approach to how frequently it inspects particular facilities,” said FDA Commissioner Scott Gottlieb, M.D. “Biologics are at the forefront of some of the most significant medical advances of the 21st 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. 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."

The FDA has issued a direct final rule that amends the general biologics regulations to remove outdated requirements and help eliminate inconsistencies and duplicative processes – specifically, how frequently the FDA is inspecting certain facilities and the actual duties of the inspector. Historically, the Federal Food Drug and Cosmetic Act (FFDCA) required biennial inspections of drug and biological product establishments. With the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012, however, the biennial inspection requirement for drug and biological product establishments was replaced with a requirement that the FDA inspect such establishments on a risk-based schedule. This change aligns with that framework and removes from the regulations the outdated biennial inspection requirement and accommodates the risk-based schedule that has been in place and in practice since FDASIA was signed into law. This change clarifies the FDA’s flexibility under FDASIA to inspect facilities either more or less frequently, according to the potential risk the establishment’s operations present, without diminishing public health protections.

The rule also removes the outdated “duties of inspector” requirements, which are unnecessary because they are duplicative of statutory requirements provided in the FFDCA. 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.

This rule applies to all licensed biological products and will help facilitate implementation of the comprehensive regenerative medicine policy framework and risk-based enforcement strategy announced on November 16, 2017 as it clarifies the FDA’s flexibility to prioritize its inspection resources to higher-risk facilities, such as those involved in the manufacture of products that raise potential significant safety concerns.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.