medpundit |
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Tuesday, September 12, 2006The risk evaluation and mitigation strategy for a drug may require that for a fixed period after initial approval, not to exceed 2 years, the applicant not issue or cause to be issued direct-to-consumer advertisements of the drug, if the Secretary determines that disclosure under subparagraph (G) is inadequate to protect public health and safety, and that such prohibition is necessary to protect public health and safety while additional information about serious risks of the drug is collected, considering-- `(i) the number of patients who may be treated with the drug; `(ii) the seriousness of the condition for which the drug will be used; `(iii) the serious adverse events listed in the labeling of the drug; `(iv) the extent to which patients have access to other approved drugs in the pharmacological class of the drug and with the same intended use as the drug; and `(v) the extent to which studies used to approve the drug may not have identified serious risks that might occur among patients expected to be treated with the drug. Direct to consumer drug advertising wouldn't be such a problem if the targets of the advertising actually spent their own money on the drugs. Do you ever wonder how much lower health insurance premiums would be if direct to consumer advertising had never been approved in the 1990's? UPDATE: The Library of Congress evidently doesn't allow direct linking, so go here and search for "S 3807" posted by Sydney on 9/12/2006 08:35:00 PM 1 comments 1 Comments:Link is bad. By KipEsquire, at 9:01 PM |
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