One regulatory hot topic that invariably sparks interest not only within the pharmaceutical industry, but also among the general public, is adverse effects. Despite rigorous pre-launch testing, many drug side effects are not discovered until after a drug is on the market. The patient population is, after all, much larger and more diverse (medically and genetically) than any clinical trial would attempt to emulate. Long-term use of a drug for chronic conditions and its unanticipated co-administration with treatments for other ailments can also uncover previously unsuspected adverse effects. When such events attract media attention, the public often demands reassurance that regulatory agencies are monitoring clinical data following drug approval.
There are, in fact, at least two mechanisms for tracking postlaunch drug experiences in the world's largest markets, the United States and the European Union. One is the mandated reporting system imposed on all drug producers. Companies must submit adverse event reports (AERs) to regulatory authorities at stated intervals throughout an approved drug's commercial life. To do so, they systematically survey the published literature for all pertinent references, as well as record all adverse events reported to them by practitioners and patients. These data are then analyzed for frequency of occurrence and relative severity, in accordance with AER guidelines. Newly identified serious and unexpected effects are subject to expedited reporting requirements above and beyond existing quarterly, semiannual, or annual AER submissions. Supplementing these company reports are national programs designed to collect adverse effect data directly from medical practitioners (usually on a voluntary basis). Taken together, the mandated and voluntary reporting systems form what is now called "pharmacovigilance."
Another component in postmarketing safety surveillance programs is the establishment of enforcement mechanisms to correct product problems. Errors can occur in drug production, packaging, and shipping that lead to adulteration, loss of potency, mislabeling, and other hazardous situations. Prompted by user reports or by results of their own internal quality control procedures, drug manufacturers routinely initiate voluntary product recalls. These actions typically involve limited quantities, or "batches," which are cited in public notices of recalls published by the FDA. Product problems that represent serious and widespread threats to public health evoke another form of official publication: Public Safety Alerts (entitled Public Safety Reports in Europe).
Information requests regarding recalls or safety alerts typically lead to analyses of a given company's or product's "track record'' for the purpose of assessing quality control, as well as potential legal liability or commercial vulnerability. Comparative recall data (numbers and class of severity) are also a component in industry benchmarking and trend-watching.
Was this article helpful?