I attended the PDA/FDA Joint Regulatory Conference in Washington, D.C. earlier this week. Experts spoke on a number of topics related to pharmaceutical regulations, quality control, USP standards, and more.
Far and away, the most common theme in all of these sessions was that users should not be afraid to contact the FDA with questions and comments. “Ask forgiveness, not permission” is definitely NOT the mantra you want to follow when dealing with products that directly impact people’s lives!
During a talk on quality systems, Scott MacIntire (Director, Division of Enforcement, OE, ORA, FDA) noted that “the door is open” to contact the FDA if issues are seen in products and if help is needed. James Morris (Executive Director, Pharma Biotech Consulting, NSF Health Sciences) added that there are plenty of free resources available, including webinars, books, and white papers.
The FDA website states, “When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.” A link is available for more information: http://www.fda.gov/Safety/ReportaProblem/
The FDA offers tips on how to make a report, and also describes the types of problems that it does NOT handle and directs users to the proper authorities — for example, the CDC, OSHA, or EPA may be the ones who need to address specific complaints: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
