The federal regulation of prescription drug advertising and promotion

Article Abstract:

In the past, drug companies promoted their products by advertisements directed at physicians, direct mail, retail sales forces, and closed or private scientific meetings. Because of the intense competition in the pharmaceutical industry, drug companies now use new approaches to promote their products, which are directed at consumers, hospitals, and third-party reimbursers, in addition to physicians. New promotional activities include holding press conferences, sponsoring media tours, opening scientific meetings to the media, issuing video news releases, sponsoring single-issue publications, and discussing drugs still in the development stage with investment groups. Drug companies also direct their advertising to the consumer in print and on television. The FDA has regulated prescription drug advertising since 1962. However, in light of the current, nontraditional promotional activities of pharmaceutical companies, the FDA has decided to take a more extensive regulatory role in controlling the current practices of advertising and promoting prescription drug products. Until a policy is developed for regulating the new promotional activities of the pharmaceutical industry, the FDA is handling each case on an individual basis. In creating a policy for regulating promotional activities, the FDA must consider that the scientific exchange of information may be difficult to distinguish from promotion of a product, and emphasis must be placed on the content of information conveyed. The risks of overuse and the potential confusion of the consumer should be balanced against the benefits of informing the consumer about a new treatment. Brief summaries, such as those provided by the Lifetime cable channel, may be inappropriate for the general public, since they tend to be written for physicians. The FDA should also consider that a description of a drug's adverse effects is never complete and tends to be related to the length of time that the drug has been on the market. Promotional activities are a source of information about prescription drugs, but should not provide inaccurate and misleading information. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Advertising, Social policy, Pharmaceutical policy, Advertising law

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Introducing MEDWatch: A new approach to reporting medication and device adverse effects and product problems

Article Abstract:

A new FDA program called MEDWatch may simplify reporting and increase awareness of diseases induced by medications and medical devices. Reporting adverse events is essential to ensure the safety of products regulated by the FDA after they are released to the market. Even large clinical trials cannot detect all potential drug interactions or measure long term safety. The new MEDWatch form consolidates all the separate forms previously used into one page. Also, all forms will now be sent to one address. The FDA protects the identities of health care professionals and patients from all forms submitted. Health care professionals should fill out a report when they suspect use of a drug or device may be related to a serious adverse effect. They do not have to establish a relation. It is especially important to report adverse effects associated with drugs or devices that have been marketed for three years or less because that is when most serious side effects are discovered.

Management, Complications and side effects, Physicians, Medical professions, Records and correspondence, Adverse drug reactions

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The legal and scientific basis for FDA's assertion of jurisdiction over cigarettes and smokeless tobacco

Article Abstract:

The FDA declared nicotine a drug and cigarettes a drug delivery device on Aug 28, 1996, giving the FDA control over their regulation. The drug classification was based on evidence of nicotine's addictive properties and the use by consumers to change moods daily. Also, evidence that manufacturers knew of these pharmacological effects, modified the nicotine levels in cigarettes and designed cigarettes as an efficient delivery system for nicotine supported FDA jurisdiction.

Physiological aspects, Nicotine, Cigarettes, Smokeless tobacco

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