International Conference On Harmonization

The FDA recently published a draft consolidated guidance for post-marketing safety reporting. CDER/CBER, Draft Guidance for Industry— Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (March 2001). This guidance covers many of the topics addressed in the previous post-marketing guidances discussed above. This guidance was prepared, however, under the auspices of the International Conference on Harmonization. In general, FDA's policy on international standards states that

[w]here a relevant international standard exists or completion is imminent, it will generally be used in preference to a domestic standard, except when the international standard would be, in FDA's judgment, insufficiently protective, ineffective, or otherwise inappropriate. 60 Fed. Reg. 53077, 53084 (1995).

Physician/Consumer Reporting: The FDA Medical Products Reporting Program (MedWatch)

In addition to receiving mandatory adverse event information from drug manufacturers and distributors, the FDA also receives voluntary adverse event reports from the medical community and consumers through its MedWatch program. The program provides a system for healthcare professionals and consumers to report adverse events to the FDA about drugs, biologics, medical devices, and nutritional products such as medical foods, dietary supplements and infant formulas. The FDA has a web site on the internet that permits healthcare professionals voluntarily to transmit adverse event information electronically and the FDA also has designed a specific MedWatch adverse event reporting form that can be submitted through the mail or fax. Internet reports can be submitted through the FDA's Web page at http:// medwatch/. The MedWatch forms are available on the internet, through the the FDA, and also appear, for example, in the Physicians' Desk Reference. Additionally, the FDA has a toll-free telephone number for reporting adverse experiences.

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