The FDA is a Pain to Gout Sufferers

Gout sufferers can thank the FDA for the 10,000% increase in the price of an old treatment.  An old drug used to treat gout (colchicines) used to cost mere pennies per tablet but now a newly approved version is $5 per pill.

As part of a push to expand its control over the sale of non-approved drugs, the Food and Drug Administration (FDA) recently gave the maker of an old gout drug (colchicines) exclusive rights to market it for three years. The period of exclusivity was in return for commissioning several studies showing this drug (that has been used for decades) was in fact, safe and effective. 

Many drugs already in existence when the FDA gained control over approval for prescription drugs were allowed to continue to be sold.  Probably the best example of this is the common aspirin. The FDA has recently begun trying to rein in some of the old drugs that predate the FDA approval process. Last month several makers of nitroglycerin tablets for chest pain were essentially told their products were not approved by the FDA and could not be sold.

Comments (4)

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  1. Stephen C. says:

    FDA pushes up drug costs? what else is new?

  2. Virginia says:

    Someone should do a count on the number of people the FDA could save if it approved all of the drugs that it’s got on its waiting list right now and compare that to all of the people that died while on Vioxx.

  3. Devon Herrick says:

    I suspect the FDA’s calculus for lives lost by being too cautious versus lives lost by approving a drug too soon would show it errors on the side of caution by a factor of 9:1. The reason is that those who die due to lack of access are never counted; while those who die from an adverse reaction are counted. The FDA lives in fear of a scandal like Vioxx that makes them look bad.

    I’ve always believed Vioxx was actually a good drug but its use precluded aspirin, which is beneficial to the heart (Cox-2 inhibitors are used by those who cannot tolerate aspirin). This alone could result in heart attacks and strokes. I’ve been told by a PhD biochemist that there is actually more to it that that – there is a (theoretical) reason why it could damage the heart. Yet there are many people at low risk for heart disease that would love to have Vioxx back on the market.

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