RE: Terminal Illness and Legality of Imports

WannaBe

Mini B
RE: Terminal Illness and Legality of Imports

In 1997, I read a book about medical freedoms in America. The author held a PhD so I took everything literally. In one of the chapters it stated that if a person had a terminal illness, they could legally import whatever they deemed necessary for their health. I have done an exhaustive search and found nothing in regards to this. Any comments or lawyers here?
 
You can't import "whatever" you want. But more lienancy is given for alternative treatments for those with a terminal illness, and it has to be an actual treatment for the problem.

I would go run some searches on http://www.fda.gov I did a quick search and found a few items:

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FDA's guidance for coverage of personal importations of unapproved drugs identifies several factors that should be considered by FDA personnel when determining whether to exercise enforcement discretion and refrain from taking action against the importation of unapproved drugs. The General Guidance Section states that FDA should consider not taking enforcement actions against such importation:

"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country."

The above guidance does not specify that a U.S. citizen may import an unapproved drug only with a prescription from a U.S. licensed physician, or that a foreign citizen may import an unapproved new drug only with a foreign prescription. Rather, to ensure that the importation is for personal use only (and not for resale), and to ensure that the use of the unapproved new drug sought to be imported into the U.S. is supervised and does not represent an unreasonable risk...


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As with all of FDA's activities, priorities are established based on benefit/risk to public health. The Agency's regulation of health fraud products is based on a priority system that depends on whether a fraudulent product poses a direct or indirect risk to public health. The susceptibility of the population is an element that is considered when determining risk. For example, terminal cancer patients would be considered highly susceptible, as many have exhausted conventional or standard of care treatments, and are desperate to try anything that may promise a cure.
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Products that are not themselves hazardous can still present an indirect health hazard in that the consumer may delay or forego proven medical treatment and the use of proven drug therapies. Examples include unproven products promoted for the treatment of cancer, Alzheimer's disease, arthritis, heart disease, and high blood pressure.
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