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[Bonus Issue] Inspection-Related Policies in the Food and Drug Omnibus Reform Act
The new omnibus package includes a number of changes that expand FDA’s inspection authorities and reform the way FDA conducts inspections.
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We recently published a review of the inspection-related policies put forward in the recently-passed Consolidated Appropriations Act, 2023. The following is an excerpt from that review, which you can read in full on our blog here.
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 into law, which contains the Food and Drug Omnibus Reform Act (FDORA). The omnibus provides approximately $6.56 billion in total funding for FDA for the fiscal year 2023.
The new FDORA contains dozens of policy provisions that will have a significant impact on the life sciences industry and FDA.
FDORA includes a number of changes that expand FDA’s inspection authorities and reform the way FDA conducts inspections, including device inspections, foreign inspections, and drug facility inspections.
Our review provides a brief look at these inspection-related policies. If you need expert assistance to prepare for these, or other new policies, contact us to access qualified RA/QA/Clinical life science consultants who can help you efficiently navigate these policy changes.
1. An expansion of FDA’s authority over medical device inspections
Section 3611 formally expands FDA’s authority over medical device inspections.
FDORA enables the FDA to request information (not only records, but other information) “in advance of, or in lieu of, inspections” from medical device manufacturing establishments (facilities that manufacture, prepare, or process devices).
2. An expansion of FDA’s authority related to BIMO inspections
Section 3612 gives FDA more authority with respect to conducting Bioresearch Monitoring (BIMO) inspections.
FDA's BIMO inspections assess sites involved in clinical research, with attention given to clinical data integrity, and revealing mistakes and potential fraud. Section 3612 of the new law gives FDA the same authority as mentioned in the previous section to allow FDA to collect records and other information when performing inspections of facilities involved in the preparation, conduct, or analysis of clinical trials.
3. The inclusion of "risk factors" (compliance history and location) to prioritize inspections
Section 3613 asks FDA to consider the “compliance history of establishments in the country or region in which the establishment is located” when it's setting a risk-based determination for inspection scheduling.
4. The creation and submission of a GAO report on foreign inspection activity to Congress
Section 3614 compels the Government Accountability Office (GAO) to submit a report to Congress on inspections of foreign facilities or inspections conducted on behalf of the FDA by a foreign agency.
5. The establishment of an “unannounced foreign facility inspections pilot program”
Section 3615 calls on FDA to conduct a pilot program to "increase the conduct of unannounced inspections of foreign human drug establishments and evaluated the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of inspection.”
6. Enhancements to the coordination and transparency of inspections
Section 3616 requires FDA to “ensure timely and effective internal coordination and alignment among the field investigators of the FDA and the staff of CDER’s Office of Compliance and Drug Shortage Program.”
7. The creation of an annual report on drug facility inspections
Section 3617 compels FDA to create an annual report on drug facility inspections, with a focus on PAI timelines.
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