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FDA Tyranny

Posted by scott r on 10/01/02 at 15:27 (096619)

One only needs to read JAMA to see how the FDA is more concerned about the profits of drug companies than allowing American consumers to have access to medications. Note the heavy hand in the business and money end of the article below and not a word about protecting or benefitting consumers. Also note that this is yet another case where the FDA had to be defeated in court to change its behavior.

Pharmacy Compounding Guidance

Lester M. Crawford, Jr, DVM, PhD

The FDA has issued a guidance on its approach to regulating compounded drugs following court decisions that have invalidated the pharmacy compounding section 503A of the Food, Drug and Cosmetic Act.

The guidance does not affect the legitimate pharmacy compounding of reasonable quantities of human drugs on the receipt of valid prescriptions for individual patients. The document warns, however, that the FDA may seriously consider enforcement action if the scope and nature of a pharmacy's activities result in significant violations of rules protecting the integrity and labeling of pharmaceuticals.

Examples of potential violations include the following: excessive compounding of drugs in anticipation of receiving prescriptions; compounding drugs that were withdrawn or removed from the market for safety reasons; compounding finished drugs from bulk active ingredients that are not components of FDA-approved drugs; receiving, storing, or using drug components not guaranteed to meet official compendia requirements; using commercial scale manufacturing or testing equipment for compounding drugs; and compounding drugs for resale by third parties, or offering compounded drugs at wholesale to commercial entities. The guidance, which is open for comments, is posted on the Internet at
http://www.fda.gov/ora/compliance_ref/cpg/default.htm

AUTHOR INFORMATION

Lester M. Crawford, Jr, DVM, PhD
Deputy Commissioner
US Food and Drug Administration

Written inquiries may be directed to Office of the Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.

Re: FDA Tyranny

elliott on 10/02/02 at 07:56 (096681)

So, Scott R, are you saying we should take any FDA-approved study with a grain of salt? :-)

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Re: FDA Tyranny

Ed Davis. DPM on 10/02/02 at 13:09 (096727)

I don't think Scott is against taking FDA studies seriously. He is concerned, like many, that this information may be used as a directive to enforce 'agency law' in a manner that suppresses the formulation of legitimate products.

I am often wary of some FDA actions. I read this carefully as I do order a number of compounded meds. It appears to be fair in its intent -- the test will be on the manner it is enforced.
Ed

Re: FDA Tyranny

elliott on 10/02/02 at 07:56 (096681)

So, Scott R, are you saying we should take any FDA-approved study with a grain of salt? :-)

[][][]

Re: FDA Tyranny

Ed Davis. DPM on 10/02/02 at 13:09 (096727)

I don't think Scott is against taking FDA studies seriously. He is concerned, like many, that this information may be used as a directive to enforce 'agency law' in a manner that suppresses the formulation of legitimate products.

I am often wary of some FDA actions. I read this carefully as I do order a number of compounded meds. It appears to be fair in its intent -- the test will be on the manner it is enforced.
Ed