2020 FDA-Held Conferences with Expenses Over $100,000
General Report
The Food and Drug Administration (FDA) hosted 2 conferences with expenditures greater than $100,000 this fiscal year. The FDA funded the conference, travel and other expenses for 498 FDA employees, 106 Federal employees and 392 Non-Federal employees. Conference sponsors included Office of Commissioner and Center for Drug Evaluation and Research conference topics included but were not limited to ensuring the safety and efficacy of prescription, generic, and over-the-counter- drug products that are available to the American public and recent policies related to compounding issued by FDA; CGMP for outsourcing facilities; process design and use of automation technology by outsourcing facilities; FDA inspectional process for outsourcing facilities; and interactions with FDA during and after inspections. All conferences funded and attended followed the applicable Federal authorities, policies and procedures. Furthermore, the conferences helped advanced FDA’s public health mission related to drug compounding and process on outsourcing facilities.
Narrative Report
See below for a summation of all conference expenditures for FY 2020.
Total Conference Net Expenses (in dollars): $429,054.60
Conference Report 1
Basic Information
Conference Title: FDA20 Intergovernmental Working Meeting on Drug Compounding
Applicable Conference Type: Scientific, FDA Hosted/Sponsored/Co-Sponsored
Conference Location: FDA White Oak Campus, Silver Spring, Maryland
Conference Start Date: 10/10/2019
Conference End Date: 10/11/2019
Cost and Attendee Information
Total agency cost of the conference: $130,192.6
Total number of individuals whose travel expenses were paid by the agency: 84
Explanation of how the conference advanced the mission of the agency
The FDA Human Drug Program is responsible for ensuring the safety and efficacy of prescription, generic, and over-the-counter drug products that are available to the American public. This meeting provided a forum for both FDA and state officials to collaborate and reach consensus regarding the best way to provide oversight of compounding pharmacies in the future.
Conference Report 2
Basic Information
Conference Title: FDA20 Reducing Risks of Compounded Drugs Engagement with Outsourcing Facilities Conference
Applicable Conference Type: Scientific, FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 9/21/2020
Conference End Date: 9/22/2020
Cost and Attendee Information
Total agency cost of the conference: $298,862
Total number of individuals whose travel expenses were paid by the agency: None/ Virtual Conference
Explanation of how the conference advanced the mission of the agency
Various offices within the FDA work together to advance FDA’s public health mission related to drug compounding. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. The Drug Quality and Security Act of 2013 created “outsourcing facilities” – a new industry sector of drug compounders held to higher quality standards to protect patient health.