The FDA’s MedWatch program, established in 1993, allows physicians, nurses or patients to report an adverse event associated with an approved device or drug. Not only does the program evaluate and generate information based on the reports, but it also makes that information available to providers, manufacturers and the public, explained Brenda J. Rose, pharmaceutical director, Office of Special Health Issues, FDA, during an Oct. 20 FDA webinar.
“When we began almost 20 years ago, the focus of the program was primarily about reporting. We also are now focused on safety-out, that is, reporting information to you. Today, once we identify new safety information about a medical product, we send this information to you,” said Rose. “Our goal is to deliver this information in a useful format and at the point of care, so that it can be incorporated into decisions about the use of particular medical product, taking into account the specific risks and benefits.”
The safety process of devices and pharmaceuticals includes preclinical testing, Phase I, II and III tests, followed by FDA review, approval and, finally, postmarket monitoring. Preclinical testing includes laboratory and animal studies, and the phase tests include public tests escalating numbers of participants and evaluation intensity.
Why are postmarket studies of adverse event reporting necessary? Because the regulatory process is not perfect. “Despite the rigorous steps in the process of drug development, there are limitations because clinical testing is often conducted with specific patient populations,” said Rose. “A true picture of a product’s safety actually evolves over the months and even years that make up a products life in the marketplace.”
Using a form provided by the FDA, anyone can inform the agency of a problem. Rose cited the example of a single report in 2004 from a 34-year-old woman with multiple sclerosis who informed the FDA of potential risk with a specific cardiac drug. The woman developed cardiogenic shock and her heart was damaged such that it could not supply enough blood to her organs. The voluntary MedWatch report prompted a review of a drug she was taking, and additional patients turned up with a decline in left-ventricle blood flow. New warnings and monitoring recommendations are now used with that particular pharmaceutical.
Upon a report being submitted, the FDA has a safety evaluator review it and look for similarities in other reports. The review may prompt a decision to consult manufacturers, which may lead to futher epidemiological studies or postmarket clinical trials, according to the webinar.
If new safety issues are found, the FDA will either make a labeling change, prepare a medication guide, require product changes in the design process, packaging or distribution or conduct a recall of the product.
Click here for more information on adverse event reporting or on MedWatch.