A recent article from Forbes Magazine highlights the extreme gaps in the U.S. Food and Drug Administration’s approval process for potentially dangerous pharmaceutical drugs. The FDA is notorious for failing to thoroughly scrutinize the claims that pharmaceutical companies make regarding the safety and effectiveness of their drugs.
The FDA recently issued a recall of a generic version of Wellbutrin XL. The 300mg generic version of this antidepressant was recalled because the FDA realized that the drug did not work and was highly dangerous to patients. Wellbutrin XL and its generics come in 150mg and 300mg sizes. The larger size was used on patients with more severe depression, but the FDA and drugmakers almost immediately began receiving complaints that the 300mg dosage had severe side effects and reduced efficacy.
Despite negative public reaction to the generic drug, the FDA did not conduct its own study into whether the drug worked but instead asked the generic drugmaker to do so. The generic drugmaker abandoned its testing due to slow patient enrollment, so the FDA eventually conducted its own testing in 2010 and completed the testing in 2012, almost five years after the first reports of Wellbutrin problems started.
In a press release the FDA admitted that the 300mg version of Wellbutrin was actually never tested before it was approved for consumer use. Instead, the FDA simply did bioequivalence studies which extrapolated data from tests of Wellbutrin XL 150mg. The FDA erroneously assumed that doubling the dosage of a powerful pharmaceutical would be safe and effective because the 150mg version of the drug was safe to use.
Forbes Magazine correctly notes that in addition to performing spectacularly bad science, the fact that the FDA allows drugmakers to test drugs whose safety has been called into question is highly problematic. Forbes also notes that this same erroneous bioequivalency test has been applied to other pharmaceuticals, so there are many high dose drugs on the market which have been approved despite being wholly untested.
Instead of recalling these pharmaceuticals, the FDA is allowing drugmakers to test the drugs, which essentially gives up the FDA’s oversight and regulatory power to the pharmaceutical companies. Results from the tests are due to the agency by 2013.
Source: Forbes, “A Drug Recall That Should Frighten Us All About The FDA,” David Maris, Oct. 10, 2012