Advertisements, and drug

Wosinska, Marta. 2005. Direct-to-Consumer Advertising and Drug Therapy Compliance. Journal of Marketing Research 42(3) 323-332. 

The regulations also address the need to ensure that drug information provided by pharmaceutical firms is truthful, balanced, and accurately communicated. As such, it must be consistent with the indications for use and the established performance and limitations. In Europe, the directives do not impose a specific requirement to review advertising or promotional material before it is released. Acceptable standards may be achieved via voluntary codes of practice and self-regulation. However, national authorities must monitor such material and should have the power to act where the need arises. In the U S, the F DA must vet advertising and promotional material before it is released. 

Food and Drug Administration (FDA) (1999) Final Guidance on Direct-to-Consumer Advertising. Federal Register 64 43,197-198, available at www.fda.gov/cder/guidance/1804fnl.htm (accessed May 26, 2002). 

Noah, L., "Advertising Prescription Drugs to Consumers Assessing the Regulatory and Liability Issues," Ga. L. Rev., 32,141-180 (1997). 

Claims are what is said in labeling and advertising, and may be either of a positive (therapeutic or beneficial) or negative (lack of an adverse effect) nature. The positive or efficacy claims are not usually the direct concern of the toxicologist though it must be kept in mind that such claims both must be proved and can easily exceed the limits of the statutory definition of a device, turning the product into a drug or combination product. 

Nonetheless, more than eight months elapsed between the first reports of deaths from Elixir Sulfanilamide and the enactment of the law (53. Two more major obstacles had to be overcome—who should control food and drug advertising, the FDA or the Federal Trade Commission, and what process of court appeal should govern FDA regulation-making—before enough consensus came to get the law passed. 

The Food and Drug Administration Modernization Act reauthorizes PDUFA and mandates accelerated reviews and regulates drug advertising of unapproved uses. 

When the NDA/BLA is approved, the Sponsor has the hcense to market the drug. It is the Sponsor s responsibility to inform the FDA of adverse events or any unexpected findings. The FDA has the responsibihty to safeguard the public s health. It monitors adverse events, advertising, and manufacturing in... 

In 1994, the Dietary Supplement Health and Education Act was passed by the U.S. Congress. This allowed herbal medications to be advertised and sold without oversight from the FDA. Specifically, it states that a substance will not legally be classified as a "drug" if it is not represented as treatment for a disease (Heiligenstein and Guenther. 1998 Dietary Supplement Health and Education Act of 1994). Thus, many herbal medicines are now sold and regulated as dietary supplements. 

The Venereal Disease Act of 1917 and The Cancer Act of 1939 had already prevented public advertisement and promotion of drugs for these conditions to protect sufferers from inadequate or unsuitable treatment and fraudulent claims (of efficacy). 

The FD C Act has been interpreted by FDA as applying only to the labelling, advertising and marketing of a new drug, not to the practice of medicine as reflected in the physician s prescription of the drug for a particular patient. In a policy first published in 1972 and reiterated many times, the FDA has stated that the physician may, within the practice of medicine, lawfully prescribe an approved drug for... 

DTCA mitigates undertreatment of the condition, but it also appears to encourage marginal and possibly inappropriate treatment. Which of these effects dominates is at this point unclear, but it is reasonable to assume that the direction and size of the net impact varies across therapeutic classes and drugs. There is also some preliminary nonexperimental evidence suggesting that consumers adherence to treatment is affected considerably by perceived safety risks, particularly when emphasized in television advertisements. 

Avorn, Jerry. 2003. Advertising and Prescription Drugs Promotion, Education, and the Public Health. Health Affairs - Web ExcZwsive W3 104-108. 

Calfee, John E., Clifford Winston, and Randolph Stempski. 2002. Direct-to-Consumer Advertising and the Demand for Cholesterol-Reducing Drugs. Journal of Lave and Economics 14(2) 673-690. 

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