Post-Market Monitoring of Medicines

Research into the best, safest uses of a medicine does not end once a drug is approved by the Food and Drug Administration (FDA). Making sure that medicines are safe and effective for their intended use is an on-going process that is closely monitored by pharmaceutical companies, prescribing physicians and the FDA. The following elements provide a brief overview of the reasons for and process used in the post-market monitoring of medicines.

• Not all safety issues can be determined through the development phase of a drug.



• Rare adverse drug reactions are often not detected during research and development because though the number of volunteer patients in clinical testing can go up to 10,000, the overall patient population is frequently much larger.



• To address this challenge, companies maintain large dedicated divisions that study safety issues after a drug reaches the marketplace.



• Serious and life-threatening adverse drug reactions must be reported to the FDA within 15 days



• During the first three years the product is on the market, companies file quarterly reports with FDA outlining all new safety issues that have come to the companies' attention. Annual reports are filed after that for as long as a company markets a drug.



• The FDA's Office of Surveillance and Epidemiology (formerly the Office of Drug Safety) deals with reported side effects not found during the drug approval process. Since 2002, user fees have made it possible for  the FDA to increase its number of safety officers.



• Nevertheless, both the FDA and companies are constantly looking at ways to improve adverse reaction detection and reporting. FDA recently created a new drug safety board within the agency.