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tion of authority over them Sure, drug makers know they must have a seal of approval from the FDA in order to sell their food products, drugs, and medical devices in the United States And sure, they wish the seal were easier to earn Yet once they get it, they sure are glad that the seal stands for a rigorous vetting (All this concerns just the day-to-day relationship of living with the FDA s regulations the pickiness part of the Type I-Type II debate The broader questions of the industry s influence on FDA policy and decisions the industry pressure part of the debate are discussed in 8.



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) In practical terms, moreover, the FDA gives the drug companies a lot of free groundwork in basic science that they would otherwise have to do themselves, like the standards it crafted in the 1960s, 1970s, and 1980s for conducting good scientific trials The National Center for Toxicological Research in Arkansas is constantly coming up with new methodologies and running toxicity experiments on chemicals, all openly available Anyone can take one of the transgenic knockout mice that the NCTR created and inject it with a chemical say, a chemical the company hopes to use in a new drug to see whether that causes a genetic mutation in the animal Even more practically, the FDA, through its requirements when reviewing a trial protocol, can help improve the structure of a clinical trial The need goes both ways.





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The FDA, under tremendous public pressure, needs the pharmaceutical, medical device, and food industries to churn out a never-ending stream of miracle cures and healthful food that will not kill people as a byproduct In order to understand the relationship between the FDA and the companies it oversees, it is important to remember the agency s mandate: The FDA is supposed to protect the public health by making sure products are safe and effective Unlike the case with the Department of Agriculture or the Federal Aviation Administration, it is not the FDA s job to promote the health of the industry On the other hand, protecting public health does not just mean checking new drugs for side effects or recalling contaminated applesauce It also means making sure the public has access to a wide choice of products that can keep people healthy.

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What is the pharmaceutical industry s relationship with the FDA It s a marriage Just like all marriages, there are times when you feel you can t live with this other person, but then you realize you re nothing without the other person (Howard J Weisman, president and chief operating officer of ESP Pharma in Edison, New Jersey, a privately owned pharmaceutical marketing company).

<span class= email >tintin@intuitive.com</span>).

Large numbers of plant preparations and extracts as well as a few from animal sources are used as traditional or herbal medicines and many of these are also marketed as dietary supplements As was seen in 1, there are a number of advantages for companies to market such products as dietary supplements so that they are subject to regulations relating to foods rather than medicines Dietary supplements can be sold over the counter in a range of outlets and the relatively loose safety, quality and honest description provisions of food legislation are enforced locally at the point of sale in the UK by trading standards of cers and environmental health of cers The value of several dietary supplements in the treatment of speci c diseases is evaluated in the chapter.

However it should be remembered that in the UK no claims that a dietary supplement can cure or be bene cial as a treatment or prevention for a disease can be made either on the product packaging, advertising or sales literature unless the product has been licensed as a medicine Perhaps the most obvious criterion that could be used to decide which preparations should be included in this chapter is that the parent plant from which the pill or potion derives should have an authentic culinary purpose, such as garlic, tea or ginger As companies nd it convenient to market substances as dietary supplements rather than traditional medicines, this criterion might exclude some substances marketed and widely referred to as dietary supplements This means that the decision about whether or not to include a substance in this chapter has been considered case by case and is therefore somewhat arbitrary.

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