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A New Approach to Reporting Medication and Device Adverse Effects and Product Problems

David A. Kessler, MD; the Working Group; Sharon Natanblut, MPA; Dianne Kennedy, MPH, RPh; Eliot Lazar, MD; Peter Rheinstein, MD, JD, MS; Chuck Anello, ScD; Dave Barash, RPh; Ilisa Bernstein, PharmD; Ross Bolger, RPh; Kay Cook, JD; Mary Pat Couig, RN, MPH; Jerry Donlon, MD, PhD; Joyce Johnson, DO, MA; Catherine Lorraine, JD; Tom McGinnis, RPh; John Nazario, RPh; Stuart Nightingale, MD; Carl Peck, MD; Mary Pendergast, JD; Suresh Rastogi, PhD; Chet Reynolds, MBA; Renie Schapiro, MPH; Linda Tollefson, DVM; Ann Wion, JD

JAMA. 1993;269(21):2765-2768.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

UNFORTUNATELY, many health professionals do not think to report adverse events that might be associated with medications or devices to the Food and Drug Administration (FDA) or to the manufacturer. That needs to change, and the FDA is taking steps to encourage that to happen.

Reports from health professionals of adverse events or product quality problems are essential to ensure the safety of drugs, biologicals, medical devices, and other products regulated by the FDA once they are introduced into the US market.

Even the large, well-designed clinical trials that are conducted to gain pre-market approval cannot uncover every problem that can come to light once a product is widely used. A new drug application, for example, typically includes safety data on several hundred to several thousand patients. If an adverse event occurs in perhaps one in 5000 or even one in 1000 users, it could be missed in clinical trials . . . [Full Text PDF of this Article]

Author Affiliations
From the Food and Drug Administration, Rockville, Md.

Footnotes
A complete list of the participants in the Working Group appears at the end of this article.

Reprint requests to Commissioner of Food and Drugs, Food and Drug Administration, 5600 Fishers Ln, Rockville, MD 20857 (Dr Kessler).

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