Bill Anderson <[EMAIL PROTECTED]> wrote in small part: >Tongue depressor: Device required to undergo FDA approval testing.
No, I'm pretty sure that one's a class I, "general controls" device. However, pre-market notification of FDA (90 days) is required before first introduction (of a new mfrs. tongue depressor) into interstate commerce IIRC. >Prior to 1962, the FDA *ONLY* concerned itself with "safety" not >efficacy. A return to this would be an improvement as well. Something I feel compelled to inject at this time is something that should've been stated a while back in this thread: that it's not as if FDA has much choice in most of these matters, and certainly none in the item mentioned above. FDA does what Congress requires it to do. And actually, even before 1962, FDA was involved in treatment efficacy determinations. I think FDA before 1962 was certifying biologicals. But that aside, Congress had given FDA responsibility concerning safety of drugs, medical devices, and food additives. Now how was FDA to determine whether such a product was "safe"? No product is completely safe, so risk had to be viewed in relative terms, vis-a-vis benefit. So FDA was already making safety determinations on the basis, in part, of efficacy determinations. If Congress were today to repeal efficacy requirements for marketing of drugs, devices, and food additives, what standard could FDA fall back on to determine such products' safety? The same question is now working its way thru the courts regarding dietary supplements, which by their very nature are not allowed to make health efficacy claims. I suppose a standard could be used somewhat like that used in determining safety of cosmetics, wherein almost a zero-risk standard is applied, but that standard could hardly ever be met by a drug, and not by many medical devices, either. Therefore I predict FDA would still make efficacy determinations for those products, but with more vagueness than that which results from phase II & III efficacy studies. >Indeed, medical experience is more and more going outside the bounds of >the federally mandated FDA process. It is known as "off label use". A >modern and, dare I say it outstanding, example is Viagra. Contrary to >popular belief, Pfizer did not set out to create a drug to handle >impotence. This was a side-effect. Viagra was initially developed for >cardio problems. Some side effect reporting in journals led some doctors >to try it out for ED. This led to clinical trails and years later, FDA >approval. >Yet the story does not end there. It is being prescribed to infants. >Why? It is being found effective in fighting infant pulmonary >hypertension. After some clinical trials Pfizer will likely go back >through the entire FDA process again. Why? Well each new use it is >classified as a "New Drug". So all those tests No, not all, just the most expensive part -- phase II & III clinicals. > get conducted *AGAIN*. If >that isn't inefficient, not much is. Forcing a drug maker to go back >through the entire process as if it had never done it merely because a >new use is found is a gross inefficiency. They're only forced to do it if they put those uses on-label, or otherwise advertise them as intended uses. However, FDA has a record of seizing products that are not at all labeled for medical use, on the basis that FDA believes such a use is intended by the purveyor (by virtue of the purveyor's knowledge of the customer's use), and then declares the products misbranded on the basis of their not having adequate instructions for use! That was how FDA seized a lot of tanks of oxygen, because apparently they'd gotten wind (heh) of the supplier's doing business with people who intended them for ozone generators, the ozone generators making health claims. So what I think would be the bigger improvement would be a statutory (or, next best, judicial) determination of "intended use" applying to all of Titles 20 & 21 U.S.C. that would make disclaimers an effective loophole in the absence of any other statements in favor of an intended use. That would apply to the Federal Food, Drug and Cosmetic Act (wherein almost all of the jurisdictional definitions are based on intended uses of articles), the analog provision of the Controlled Substance Act, and the Federal Insecticide, Fungicide, and Rodenticide Act (which applies also to disinfectants, sterilizers, pest repellents, and plant growth regulators). Well, except for one catch -- state pharmacy laws, which are for the most part on the same basis. In other words, if the feds couldn't act, the states still could and probably would. The only reason that's not a problem now is that the state laws say that a food, drug, etc. product legally sold in interstate commerce is allowed intra-state too. If you had people supplying "general-use articles" disclaiming medical use, and federal law excluded those from the regulated categories, state pharmacy boards would probably make the same types of determinations FDA made in seizing oxygen bottles, etc. So you'd need the states to adopt a conforming change. In Your Sly Tribe, Robert _______________________________________________ Libnw mailing list Libnw@immosys.com List info and subscriber options: http://immosys.com/mailman/listinfo/libnw Archives: http://immosys.com/mailman//pipermail/libnw
