Since 1997, when FDA eased rules for DTC advertising, companies have greatly expanded their use of it to promote drugs via the mass media (Gahart et al., 2003; Gilhooley, 2005). According to a 2004 study (Brownfield et al., 2004), the average television viewer spends 100 minutes watching DTC advertising for every minute in a doctor’s office. Typically, less is known about the safety of a new drug than of an older drug on the market, but the public is not likely to be aware of this and may simply assume that a new drug is a better drug.

Spontaneous Adverse Event Reporting System

The FDA’s primary source for managing and monitoring new adverse effects of marketed drugs is the Adverse Event Reporting System (AERS), an automated system for storing and analyzing safety reports. ODS/OSE has primary responsibility for AERS (FDA, 2004c).

Adverse event reports have several sources. When an adverse event is both serious11 and unexpected (not listed in the drug product’s current labeling), drug sponsors are required to report it to FDA within 15 calendar days (“15-day reports”). Sponsors must also submit periodic reports that summarize all adverse events quarterly for the first 3 years after the NDA was approved and annually over multiple years (FDA, 2005a).

Another source of spontaneous reports is FDA’s voluntary reporting system, MedWatch, which covers drugs and other FDA-regulated products. MedWatch enables health care professionals and consumers to file adverse event reports directly to FDA via telephone, completion of FDA Form 3500 online, or via fax or mail (FDA, 2003).

FDA receives more than 400,000 spontaneous reports each year as part of the surveillance system. In FY 2004, for example, ODS/OSE received 422,889 adverse event reports (see Box 2-5 for a breakdown) (FDA and CDER, 2005). Although exact figures are not available, that is assumed to represent a small fraction of all adverse effects of drugs. The system contains 3–4 million reports accumulated from multiple years (FDA and CDER, 2005).

Most adverse event reports arrive on paper via fax. ODS/OSE has placed a high priority on increasing the number of reports filed electronically to both expedite and reduce the cost of receiving and processing the report. In FY 2004, 16 percent of all reports were submitted electronically, up from 10 percent in FY 2003 (FDA and CDER, 2005). In the European


A serious adverse event is any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect (CFR 312.32).

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