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.
For a top-line distillation of these policy changes, we suggest you read this in-depth review from the law firm Arnold & Palmer. They've done an excellent job collating and summarizing the relevant, new FDA provisions across the following areas:
- Development and Review of Medical Products
- Mitigating Shortages of Medical Products
- Reauthorizations
- Drugs and Biologics–Research, Development and Competition Improvements
- Drugs and Biologics–Transparency, Program Integrity and Regulatory Improvements
- Medical Devices
- Infant Formula
- Cosmetics
- Clinical Trial Diversity and Modernization
- Inspections
- Miscellaneous
Rather than re-hashing their review, we thought we'd zoom into and expand on one area of policy change that will likely be of top concern to RA/QA/Clinical teams: inspections.
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.
This guide provides a brief look at what has been put forward. 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).
For context, FDA was granted the authority to collect this information from pharmaceutical facilities in 2012 under the FDA Safety and Innovation Act. But until now, regulators have not had similar authority over medical device establishments.
This has unsurprisingly been an impediment for FDA in conducting remote regulatory evaluations in the device space. Regulators simply didn't have the authority to request or compel documents and records from certain facilities.
Section 3611 amends 21 U.S.C. 374(a) to extend FDA’s authority over “any records or other information that the Secretary may inspect” to medical device products, allowing them to be requested “in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form.”
- FDA is also required to provide “a rationale [emphasis ours] for requesting such information in advance of, or in lieu of, an inspection.”
- FDA will need to issue guidance on this new authority within one year, including a description of processes for how companies can respond to its requests and factors FDA will consider for evaluating the timeliness or completeness of a company’s response to its request.
📜 Jump to Section 3611 of H. R. 2617 (PDF) »
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.
- This authority also extends to persons involved in the trial process (such as IRBs and contractors).
- FDA can access “any electronic information system” used by a company to hold, process, analyze, or transfer clinical records.
- FDA can also record or copy this information.
- FDA's authority has been expanded beyond clinical and non-clinical studies conducted in advance of approval to include all postmarket safety activities, “other clinical investigation[s]” of a drug or device, or “other submissions … [for] which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.”
- FDA is also required to issue guidance on its approach to BIMO inspections.
📜 Jump to Section 3611 of H. R. 2617 (PDF) »
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.
The idea of FDA prioritizing its inspection schedule based on certain risk factors isn't new.
- In 2018, FDA's CDER published and implemented a Manual of Policies and Procedures (MAPP) describing the Site Selection Model (SSM) used to prioritize manufacturing sites for routine CGMP surveillance inspections under a risk-based approach. Read our report on this in our other guide.
- FDA's most recent (as of January 2023) OPQ report on the state of pharmaceutical quality (for fiscal year 2021) provides a breakdown of quality issues and where they are most prevalent by location/region.
- In its previous state of pharmaceutical quality report (for fiscal year 2020) FDA reported it uses a machine learning regression model called XGBoost "to model and predict the SIS [Site Inspection Score] using inspection data from 10 years of inspection outcomes."
FDORA also calls on FDA to assess “whether additional arrangements and agreement with a foreign government or an agency of a foreign government” are appropriate for the purposes of recognizing their inspections.
FDA is also provided the authority to “rely on any records or other information […] to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections.”
📜 Jump to Section 3613 of H. R. 2617 (PDF) »
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.
The report must provide information on a few areas:
- The use of alternative tools.
- The use of MRAs to inspect facilities in India or China.
- How frequently “trusted foreign regulators” conduct inspections that could be relied upon by the FDA in lieu of its own inspections.
- Whether FDA is considering or has already considered other MRAs.
- The tools FDA uses for conducting domestic inspections that it wants to use for foreign inspections.
The report is due within 18 months of the bill’s passage.
📜 Jump to Section 3614 of H. R. 2617 (PDF) »
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.”
The agency must analyze these differences, including “barriers to conduct unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections”—and publish a public report.
📜 Jump to Section 3615 of H. R. 2617 (PDF) »
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.”
Better coordination is intended to avoid instances where inspectors inadvertently act or provide recommendations that could lead to a drug shortage. FDORA also requires additional reporting by the FDA across a few areas, including MRAs for inspections and other review activities.
📜 Jump to Section 3616 of H. R. 2617 (PDF) »
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.
This section calls for FDA to include on its website, “information related to inspections of facilities necessary for approval of a drug” (both new and generic drugs) during the last year, within 120 days of the law’s passage.
The report must include information like:- Median time between FDA’s request to inspect a facility and the actual inspection.
- Time between an inspection and a compliance action.
- The number of facilities that failed to implement adequate CAPAs following an inspection, “resulting in a withheld recommendation for an application under review.”
📜 Jump to Section 3617 of H. R. 2617 (PDF) »
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