Promoting drugs on the Internet: FDA ponders new rules for drug, device ads

Article Abstract:

The FDA is considering changes to its rules governing information dissemination by manufacturers of regulated medical products because of changes in information flow created by the Internet. The FDA's rules, especially those which control promotion of off-label uses of drugs or experimental procedures, may no longer be practical. A request for input in the Sep. 16 Federal Register asked specifically about information services such as Web site links, international information flow, and chatrooms.

Telegraph & other communications, Specialized Telecom Services, Wired Telecommunications Carriers, Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors, Medical Instruments and Supplies, Medical Instruments & Equipment, Medical Equipment and Supplies Manufacturing, Health Regulation, Laws, regulations and rules, Internet, Health care industry, Internet services, Medical equipment, Medical equipment and supplies industry, Medical equipment industry, Medical law, Electronic marketing

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Physicians to get more data on pediatric drug dosages

Article Abstract:

The US Food and Drug Administration (FDA) relaxed its demands for clinical trials to determine pediatric dosages and agreed to let pharmaceutical companies extrapolate children's doses for certain drugs from studies on adults. This will provide information to help physicians recommend appropriate doses of drugs that have undergone no pediatric trials. The FDA plans to press drug makers to increase pediatric studies.

Administration of Public Health Programs, Health Programs, Standards, Public health, Labeling

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Drug ads casting wider net, finding a home on the Web

Article Abstract:

Drugmakers, braving a regulatory vacuum, have begun to promote their products on the World Wide Web. In Jun 1995 Upjohn Co launched a Rogaine (minoxidil) Web site that offers a localized list of recommended physicians and a $10-off coupon for a physician visit. Some companies are reluctant to market their products on the Internet, MediScience president Arthur Hill noted, because of a lack of FDA regulatory guidance.

Usage

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