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Regulatory Focus™ > News Articles > 5 > FDA Withdraws Final Rule to Cut Biologics Inspections

FDA Withdraws Final Rule to Cut Biologics Inspections

Posted 04 May 2018 | By Zachary Brennan 

FDA Withdraws Final Rule to Cut Biologics Inspections

The US Food and Drug Administration (FDA) on Friday withdrew a direct final rule to amend the general biologics regulations on inspection time requirements and to remove inspectors' duties.

FDA said in the Federal Register: “The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.”

In January, FDA called the biennial inspection schedule “outdated and unnecessary” because since July 2012, when  the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, the biennial requirement was replaced with a requirement that FDA inspect drug establishments in accordance with a risk-based schedule.

The about face follows explanations from the agency on why they'd initially found them unnecesssary.

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

“These changes are designed to remove the existing codified requirements that are outdated and to accommodate new approaches, such as a risk-based inspection frequency for biological product establishments, thereby providing flexibility without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,” FDA said in the 26 January Federal Register. “FDA is issuing these revisions directly as a final rule because the Agency believes they include only noncontroversial amendments and FDA anticipates no significant adverse comments.”

The number of biologics inspections the agency conducted for HCT/P inspections had declined between 2013 and 2017, and current shortages of CBER-related products have persisted.

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