Therapeutic claims

Sherley Amendments prohibit labelling medicines with false therapeutic claims intended to defraud the purchaser. 

Identifying the Most Important Laboratory Analytes to Monitor in a Clinical Trial. A choice often must be made among the numerous laboratory analytes that could be measured in a clinical trial. This choice is based on (1) past experience with the treatment(s) being evaluated, (2) therapeutic claim, (3) cost of the tests, (4) convenience of obtaining samples, (5) resources available, (6) state-of-the-art concept of the data s importance, and (7) the ability of data obtained to convince both regulators and medical practitioners. To arrive at a decision given these and other previously discussed factors may be difficult. 

The Sherley Amendment passes to prohibit false therapeutic claims in medicines. 

It is easy to see why an SPC coming out of this procedure is usually a highly effective document in terms of the therapeutic claims allowed, a dose schedule that is carefully scrutinised, and detailed safety information and/or monitoring requirements. In rare instances, the SPC comes out too restricted or unbalanced because of the differences in medical practices and cultures among the Member States. 

Fluoride varnishes have been used since the 1970s, and found to be effective in preventing caries. Their use has been predominantly in Europe, and also Canada, because there have been legal difficulties in the United States over the therapeutic claims of such varnishes to be anticariogenic. As they are intended to remain in place beyond the period of time for which the treatment is under the direct supervision of a clinician, this implies that this product is a drug. As such, proper clinical trials are required before the product can be marketed in the United States [189]. 

Further, ginseng constituents are polysaccharides, essential oil constituents, polyacetylenes, peptides, and other lipids (7). Ginseng is included in the pharmacopeias of several countries such as China, Germany, and the United Kingdom (113). Modern therapeutic claims refer to vitality, immune function, cancer, cardiovascular diseases, and sexual function (114,115). More than 500 studies have been published on the pharmacological activity of ginseng (7,80). 

Failed USP dissolution test requirements Microbial contamination of non-sterile products Lack of efficacy Impurities/degradation products Lack of assurance of sterility Lack of product stability Labeling Label error on declared strength Misbranded Promotional literature with unapproved therapeutic claims... 

In 1972 the Federal Drug Administration (FDA) initiated an OTC drug study. The final report of seventeen advisory panels was issued in 1983. Only one-third of the 700 active ingredients in some 300.000 OTC products were found to be effective. Then in November 1990 the FDA banned 223 drugs found in OTCs because their therapeutic claims were unsubstantiated. All of the products affected had been in use since before 1962. 

For all herbs, any number of therapeutic claims have been made over the ages. Many have been verified scientifically. Others are supported by centuries of traditional use or by anecdotal accounts that have not been validated scientifically. This doesn t mean that such uses don t hold water. It means that science hasn t bothered to investigate or test these health-promoting claims. By contrast, because of either misinformation, misinterpretation, or outright deception motivated by greed, false claims have been made on behalf of many plants. Those claims have not withstood, or could not withstand, scientific scrutiny. 

United States Congress enacts the Shirley Amendment that prohibits false therapeutic claims in advertising or labeling medicines. 

Protection from regulation as food additives or as drugs unless the product contains therapeutic claims... 

This phase comprises publication of those drugs that may be marketed for specific indications, and also nonmonographs, which describe drugs or indications for which no claims can be made. For example, the advisory panel on aphrodisiacs failed to find any products that could be recommended for that therapeutic claim, and regulations barring the offering of products for a specified indication fall under the nonmonograph classification. 

The active ingredients section of the monograph lists the acceptable materials for a given therapeutic claim and even goes so far as to specify what other drugs... 

Unlike the prescription drug requirements that insisted that every agent in a combination work toward the same end, OTCs offer a greater degree of liberality, as long as a collection of symptoms, as in the example above, may reasonably be found together. Similarly, under some circumstances, components that are truly ineffective may be permitted in a formulation as long as no therapeutic claims are made for them. 

Food, Drug, and Cosmetic Act of 1938 Required medications to demonstrate they are safe Prohibited pharmaceutical industry from making false therapeutic claims... 

Placebo-reactois are suggestible people and likely to respond favourably to any treatment. They have misled doctors into making false therapeutic claims. 

Grant of an official licence to make therapeutic claims and to sell (see Chapter 5)... 

Other countries did not take on board the lesson provided by the USA and it took the thalidomide disaster of 1961 (Chapter 5, Appendix) to make governments all over the world initiate comprehensive control over aU aspects of drug introduction, therapeutic claims and supply. Those governments that already had some control system strengthened it. 

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