FDA and Prescription Drug Reform

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The FDA budget needs to be doubled to deal with the safety of the food supply and the crisis in the integrity of the pharmaceutical industry.  Many articles have been written about the pharmaceutical industry promoting their proprietary drugs despite questionable efficacy.  There are many documented cases of drug companies suppressing test results that might question the efficacy of their proprietary drugs.  The FDA should be more vigilant in dealing with issues of drug efficacy.

There is another, less widely discussed problem with prescription drugs.  Americans expect their pharmacies to dispense the drugs prescribed by their doctors, with the correct dosage on the label.  However, there is a growing problem of prescription drugs from unregulated factories not meeting quality standards.

American and European drug plants are closing as Chinese and Indian plants undercut them in price.  The Chinese and Indian drugs are purportedly pharmaceutically identical to the American and European drugs they replace, but is that assertion really true and are they safe?  No-one really knows, because the FDA rarely inspects drug manufacturing plants outside the United States.  Any company importing drugs or pharmaceutical ingredients into the United States is supposed to test the supplies before using them.  However, Chinese manufacturers are notorious for giving samples that pass tests and then changing the ingredients or the manufacturing process after passing the sample test.  In 2008, Chinese manufacturers substituted a cheap fake for dried pig intestines used to make heparin, which is used to prevent clotting during surgery and dialysis.  81 people died of allergic reactions and tens of thousands of people around the world were exposed to danger before the FDA got the situation under control.  This is not an isolated case.  It is estimated that 8% of over-the-counter drugs in China are counterfeit.[i]

One often-mentioned way to reduce medical expenses is to encourage the use of generic drugs.  The asserted reason is that generic drugs are not only much less expensive, but also pharmacologically equivalent to brand name drugs.  However, the healthcare reform discussion often neglects the lack of FDA regulation of generic drug manufacturers, especially the lack of inspection of the increasing number of drug manufacturing plants outside the United States.  Not only are generic drugs often different from their supposed brand-name equivalents, but drug potency varies from manufacturer to manufacturer.

For example, practicing pharmacists are aware that warfarin, the generic version of coumadin, is not actually equivalent to coumadin.  Coumadin (and warfarin) is an anticoagulant drug, and the wrong dosage of this drug can lead to internal bleeding, including hemorrhage, with serious consequences.  Hungarian warfarin has been found to be 20% higher effective dosage than Indian warfarin of the same nominal dosage, with brand-name Coumadin falling in between.  (I found this out when I refilled a warfarin prescription that was randomly dispensed with warfarin manufactured in a different country, and my INR changed by 30% at the next weekly test.)

Another example is the recent (September 24, 2008) FDA list of 32 finished drugs and 7 active pharmaceutical ingredients manufactured by Dewas and Paonta Sahib facilities of Ranbaxy Laboratories, banned because those sites failed to pass FDA inspections.  We do not know how long those drugs were on the market in the United States before the inspections.

The FDA budget should be doubled.  The FDA should promulgate a rule that neither drugs (whether prescription or over-the-counter) nor their ingredients may be imported into the United States unless the FDA has inspected the manufacturing plant within a year of importation.  The inspection costs should be recovered by fees imposed on the drug manufacturers.  Improve the FDA drug manufacturing plant database.  Also develop a source database system for all produce sold in the United States.


[i] http://www.nytimes.com/2008/11/02/magazine/02fda-t.html?scp=1&sq=The%20Safety%20Gap%20Gardiner%20Harris&st=cse

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