FDA/ORA Efforts to Ensure Product Safety
Drug tampering and product
substitution in healthcare facilities
Article by Catherine Hermsen,
for Criminal Investigations, FDA/OCI
(Journal of Healthcare Protection
The FDA’s Office of Regulatory Affairs (ORA) uses a robust, risk-based oversight approach to ensure the safety of foods, drugs, and medical products for all Americans.
Our multi-pronged efforts include:
- Inspections of food and drug facilities across the United States and world.
- Investigations, including Criminal Investigations, of fraudulent and other criminal activities that threaten public health.
- Laboratory Testing of potentially harmful foods, drugs, and other medical products.
- Screening, with boots on the ground, of all food, drug, and medical product imports into the United States.
- Remote Regulatory Assessments, to ensure industry compliance, remotely and safely, during the COVID-19 pandemic.
- Domestic Mutual Reliance
- Information from capable foreign regulatory partners where there are mutual recognition agreements for drugs,
- Information from trusted foreign regulatory partners under the single audit program for medical devices, and
- Information from trusted foreign regulatory partners where we have systems recognition for foods.
Keeping Watch During the COVID-19 Pandemic
The pandemic posed unique challenges to our usual “on the frontlines” regulatory efforts, but ORA readily adapted, both logistically and technologically, to ensure continued protection of public health. We expanded use of our remote surveillance tools and employed other oversight approaches too—all while remaining vigilant about protecting the public, employees at the firms FDA inspects, and our staff from the continued harms of COVID-19.
The Resiliency Roadmap for FDA Inspectional Oversight detailed these efforts and outlined our plans for returning to a more traditional state of inspections and oversight.
And for more on how we exceeded our goals, despite the steep challenges of a global pandemic, we welcome you to read our 2021 annual report.
- Exceeded its goals for completing domestic surveillance inspections as outlined in the Resiliency Roadmap’s “base-case scenario.”
- Completed inspections and/or assessments in support of all seven of the identified mission critical applications.
- Made decisions on nearly half of the 68 applications reported as delayed due to a pending inspection or assessment in the Resiliency Roadmap.
- Exceeded its goal related to following up on previous inspections classified as official action indicated (OAI).
- Made more than 1,300 requests to human and animal drug and biological product manufacturers to submit records for review, which supported timely regulatory decisions.
- Conducted more than 130 remote regulatory assessments under the bioresearch monitoring program that were directly used in application decisions.
For More Information
- Integrated Food Safety System (IFSS)
- An update to the Resiliency Roadmap for FDA Inspectional Oversight (November 2021)
- The Resiliency Roadmap for FDA Inspectional Oversight (May 2021)
- Press release: The Resiliency Roadmap for FDA Inspectional Oversight (May 5, 2021)
- FDA Voices articles on the importation of food and medical products, how we protected patients and consumers from fraud and our inspectional tools during the pandemic