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Generic Drugs


By tovarichpeter   Follow   Mon, 3 Sep 2012, 3:11pm   431 views   4 comments
In South San Francisco CA 94080   Watch (0)   Share   Quote   Permalink   Like   Dislike  

http://www.snopes.com/medical/drugs/generic.asp

Mr. Wilson did a thorough research, and checked out all the major drugstore chains, discount chains, independent pharmacies, and even checked on some Canadian pharmacies. So often, we blame the drug companies for the high cost of drugs, and usually rightfully so. But in this case, the fault clearly lies with the pharmacies themselves.

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  1. elliemae


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    1   4:51pm Mon 3 Sep 2012   Share   Quote   Permalink   Like (1)   Dislike  

    That's how pharmacies can offer $4.00 generics. They draw people in with the low prices and hope to fil the expensive ones too.

  2. curious2


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    2   6:14pm Mon 3 Sep 2012   Share   Quote   Permalink   Like (1)   Dislike  

    tovarichpeter says

    the fault clearly lies with the pharmacies themselves

    The fault lies with the 1950s change to the FDA that began legally requiring prescriptions. It was the unfunded precursor of the latest individual mandate. In Mexico, they don't have this problem. In this country, you are a revenue center, and every lobby that can buy politicians is allowed to set up a toll booth between you and whatever you might need. Higher prices are simply the result of power-hungry politicians and revenue-hungry CEOs using your government as a tool to extract more money and power for themselves at your expense.

  3. zzyzzx


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    3   7:34pm Fri 14 Sep 2012   Share   Quote   Permalink   Like   Dislike  

    curious2 says

    The fault lies with the 1950s change to the FDA that began legally requiring prescriptions.

    Got a link to that?

    According to this:
    http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm093550.pdf

    It's 1938 Congress passes The Federal Food, Drug, and Cosmetic (FDC) Act of 1938. FDA states that sulfanilamide and other dangerous drugs must be given under the
    direction of a medical expert. This begins the requirement for prescription only (nonnarcotic)
    drugs (see 1951 Durham-Humphrey amendment).

    With an amendment in 1951 that you are probably referring to (and might have been more encompassing than the 1938 law):
    Congress passes the Durham-Humphrey Amendment, which defines the kinds of drugs
    that cannot be used safely without medical supervision. The amendment limits sale of
    these drugs to prescription only by a medical professional. All other drugs are to be
    available without a prescription.

    So, before 1938 no prescriptions required, and before 1951 some prescriptions are required, if I understand this correctly.

  4. curious2


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    4   7:40pm Fri 14 Sep 2012   Share   Quote   Permalink   Like (1)   Dislike  

    zzyzzx says

    Got a link to that?

    I'll look for a link but I think you've found most of it. The original Food and Drug Act established the agency but it didn't have so much power over individuals. Then in the 1950s it was amended, that's probably the 1951 amendment you found, to say that any "prescription" drug sold without a prescription would be considered "misbranded." In other words, the original Act prohibited the sale of "misbranded" drugs, i.e. a kind of anti-fraud measure, and allowed FDA to say certain drugs should be designated as prescription drugs, then the amendment allowed FDA to say that anything on their prescription list sold without a prescription was per se misbranded, even if everyone involved knew exactly what was in it. In other countries, there may be a prescription label, but nobody contends the package is "misbranded" simply by being sold without a prescription; the branding is the same either way. BTW, the Act changed again in the 1980s to allow prescription drugs to be advertised DTC, which had been prohibited previously.

    P.S. A quick search led to this summary, which is consistent with what I recall from when I read about the issue in print books 20 years ago:

    1939-40
    FDA regulations create a class of drugs which may be dispensed only
    by prescription and only for stated uses. FDA hangs its hat on its
    mandate to stop "misbranding" (once intended to stop consumer fraud,
    as you may recall) and on act language stating that labels must state
    the uses for which drugs are recommended or prescribed. Ipso facto,
    by FDA logic, some drugs must be prescribed in the first place, and
    FDA must approve the stated uses! These regulations wrest the choice
    of drug therapies from the consumer and place it in the hands of the
    cartel. (After a 12-year struggle, the Alberty Food decision in 1950
    and the Durham Humphrey amendment in 1951 will endorse and codify
    FDA's regulatory action).
    http://keithlynch.net/les/doc8.html

    FDA tells the same history with its own spin:
    http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm
    If you'll note, FDA conflates the drug approval process (which supposedly requires approval of safety and efficacy, and would be a good idea if actually enforced) with the control over the entire process (which is mainly about maximizing power and revenue).

    Here is an academic paper describing the history, noting other research into the significant costs, and finding there is little health benefit:

    http://research.chicagobooth.edu/economy/research/articles/38.pdf

    This article describes the history similarly:

    "It was not until 1951, when Congress enacted the Durham-Humphrey Amendments to the law, that the two drug categories were created. Before that, the classification of a drug as prescription-only was largely at the discretion of the manufacturer." [Meaning, the manufacturer could suggest, like a "manufacturer's suggested retail price," and might even use civil means like limiting its own sales to pharmacies that complied, but there was no criminal penalty.]

    The article describes the advertising history, saying ad regulation started in 1906:
    Although Congress has differentiated advertising of prescription drugs from that of OTC drugs, no formal regulations have set DTC advertising apart from direct-to-physician advertising. Until the early 1980s, pharmaceutical advertising was mainly aimed at medical professionals. In 1983, after companies had begun advertising directly to consumers, the FDA requested a voluntary moratorium on DTC advertising. Two years later, the moratorium was lifted without any new regulations or requirements.

    http://www.minnesotamedicine.com/Default.aspx?tabid=3351

    Similar history of DTC ads here:

    http://www.kevinmd.com/blog/2010/09/dtc-advertising-history-fda.html
    Apparently DTC ads of prescription drugs were never banned, but nobody used them during the FDA era until Merck in 1981. That surprises me a little because as I recall the Chairman of Abbott Labs testified before Congress that drug companies shouldn't be allowed to advertise prescription drugs DTC, and was ignored. DTC advertising has diverted $ away from research and into ads, but has enabled PhRMA to wrest control over the evening news and therefore most politicians.

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