The dominance of managed care organizations as buyers of drugs and medical devices raises regulatory concerns over development and marketing practices

Article Abstract:

Pharmaceutical and medical equipment companies, in their marketing attempts to meet the needs of managed care organizations (MCOs), have run up against regulations from several federal agencies. The companies, recognizing MCOs' focus on cost containment, have used direct-to-customer advertising, rebates and discounts, as well as developed promotional and educational programs. They have also attempted vertical integration acquisitions. These methods have been challenged by the Federal Trade Commission, Food and Drug Administration, and the Health Care Financing Administration.

Administration of General Economic Programs, Administration of Public Health Programs, Admin. of general economic programs, Federal Trade Commission, Health Care Financing Admin, Marketing, Influence, Medical equipment and supplies industry, Medical equipment industry, Managed care plans (Medical care)

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ICH sets standards for drug developers; conference with the E.U. and Japan seeks to reduce drug approval time, cost

Article Abstract:

The International Conference on Harmonisation (ICH) was founded in 1989 to devise common standards for the regulation of the pharmaceutical industry in the United States, Japan and Europe. The organization's goals are to decrease the costs involved with getting agencies to approve a new drug and thereby increase patient access to such drugs. One goal is to make it so expensive, lengthy clinical trials will not have to be repeated in each country. The Food and Drug Administration has been actively involved in the ICH process.

Standards, Management, Europe, Japan, Harmonization of laws, International Conference on Harmonisation

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Drug ads could spell legal trouble; consumer campaigns may result in greater liability

Article Abstract:

Drug companies' aggressive direct-to-consumer advertising campaigns, in which patients are urged to ask their physicians for specific products, may ultimately increase companies' products liability exposure. The ads may be compromising the traditional learned intermediary rule, which shields drug companies by making doctors primarily responsible for drug administration risks. Consumer ads may prove to be an exception to this rule, which is certain to be tested by lawsuits characterizing on-screen warnings as insufficient.

Interpretation and construction, Forecasts and trends, Advertising, Product liability, Products liability, Advertising law

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