FDA Plans Update for Risk-Based Inspections for BiologicsBy
The US Food and Drug Administration (FDA) has amended the general biologics regulations relating to the frequency of inspections by removing requirements for biennial inspection requirements to reflect the agency’s move to risk-based inspections. The changes are being made to update outdated language to reflect changes made in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
The changes apply to biologics regulated by the FDA’s Center for Biologics Research and Evaluation (CBER), which regulates blood, blood components, gene-therapy products, human tissues, cellular products, vaccines, and xenotransplantation products. FDA’s Center for Drug Evaluation and Research (CDER) regulates prescription drugs (small molecules and biologics), generic drugs, and over-the counter drugs.
“These changes are designed to remove the existing codified requirements that are outdated and to accommodate new approaches, such as a risk-based inspection frequency for biological product establishments, thereby providing flexibility without diminishing public health protections,” the FDA said in a Federal Register notice on January 26, 2018. The authority for the FDA to conduct establishment inspections is included in both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service (PHS) Act. Before July 9, 2012, the date FDASIA, was signed into law—section 510(h) of the FD&C Act further provided, among other things, that drug and device establishments registered with the FDA must be inspected at least once in the two-year period beginning with the date of registration and at least once in every successive two-year period thereafter. With the enactment of FDASIA, however, the biennial inspection requirement for drug establishments in the FD&C Act was replaced with a requirement that the FDA inspect drug establishments in accordance with a risk-based schedule established by the FDA.
This action is part of the FDA’s implementation of Executive Orders issued by President Donald Trump on February 24, 2017 relating to regulatory reform. One of the provisions requires agencies to evaluate existing regulations and make recommendations to the agency head regarding their repeal, replacement, or modification, consistent with applicable law.
As one step in implementing the executive order, the FDA published a notice in the Federal Register of September 8, 2017 entitled “Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements.” In that notice, the FDA announced that it was conducting a review of existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of, and support, advances in innovation that have occurred since those regulations took effect. As part of this initiative, the FDA is updating outdated regulations as specified in this rule. This rule is effective June 11, 2018.
FDA issued a direct final rule as well as a companion proposed rule.
The FDA is accepting comments on the direct final rule or its companion proposed rule by April 11, 2018. If the FDA receives no significant adverse comments within the specified comment period, the agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on the direct final rule ends. If timely significant adverse comments are received, the agency will publish a document in the Federal Register withdrawing the direct final rule within 30 days after the comment period on this direct final rule ends. The companion proposed rule provides the procedural framework to finalize the rule in the event that the direct final rule receives any significant adverse comment and is withdrawn. The FDA is publishing the direct final rule because it says “we believe the rule contains noncontroversial changes and there is little likelihood that there will be significant adverse comments opposing the rule.”
Source: FDA (Federal Register)