OBJECTIVE
Safeguarding the nation’s food, drug, medical and radiological devices, animal drug and feed, and tobacco product supply is no small task. To help protect and promote public health, the FDA utilizes information technology (IT) solutions.
At the forefront of this mission is the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA). As the lead office for all FDA field activities, ORA serves as the eyes and ears of the agency.
The ORA is responsible for the following:
- Inspections of FDA-regulated products
- Investigations of consumer complaints, emergencies, and criminal activity
- Sample collection and analysis
- Review of imported products
CHALLENGE
In order to achieve its mission, the ORA requires extensive system capabilities for imports, criminal investigations, and Systems for Inspection, Recalls Compliance, and Enforcement (SIRCE).
These applications are amongst FDA’s most heavily used, with over 6,000 total users located in 20 district offices, more than 150 resident posts and border stations, 13 laboratories and several international offices. The problem was that ORA systems, while critical to day-to-day operations, were running on outdated technology.
SOLUTION
In August 2017, the FDA acknowledged the need to upgrade and replace many of the ORA’s legacy systems. Legacy systems, or outdated computing software and hardware, are costly to maintain, vulnerable to security breaches, cause data silos and limit growth.
To modernize their outdated technology, the ORA turned to Leidos, a global information technology company. Leidos leveraged its extensive network of partners and employed the expertise and capabilities of AI-Vets.
RESULTS
Since March 2017, AI-Vets has supported the ORA’s mission to promote and protect public health through the development, modernization, enhancement and operation of over 30 mission-critical applications related to SIRCE systems. Now more than ever, the SIRCE program is crucial to maintain a safe and efficient supply chain of food, drugs and medical devices to the American public.
DATA
With the help of this new technology, ORA systems performed the following in 2019:
- Nearly 45.2 million imported products entered
- 40,066 samples collected and analyzed
- 35,029 inspections performed
- 14,949 warning letters issued
- 7,893 products recalled
Additionally, ORA assisted the Office of Criminal Investigations with the following:
259 arrests
$1.359 billion assets forfeited and seized
$1.628 billion fines and restitutions
CONCLUSION
Today, AI-Vets continues to upgrade and support the integration and reengineering of mission-critical systems that enable the ORA’s mission to protect consumers and enhance public health.
