Drug Recall Casts FDA In Less Than Positive Light

A generic version of Wellbutrin XL was recalled last week as the Food and Drug Administration announced that the drug did not work. The recall did not involve a specific batch of the defective drug, but rather it was the conclusion of the FDA that the drug never worked. This is problematic, given that the drug has been on the market for more than four years and was apparently approved by the FDA in 2006 without ever being tested.

The antidepressant drug is sold in two dosages, a low dose of 150 milligrams and a higher dose of 300 mg. The issue here is the efficacy and safety of the 300 mg dose. After granting approval to several drug companies to make the 300 mg dose, the FDA started to receive complaints that it was causing side effects and was not effective in treating depression. After numerous complaints were received about the untested dose, the FDA asked the drug maker to do a study to determine if the new generic was equivalent to the original, brand name drug. The drug maker eventually decided to abandon the study when it claimed that too few patients were signing up.

After nearly 5 years had passed since the first consumer complaints started to come in, the FDA completed a study that concluded that the 300 mg dose of the generic was ineffective. More than one month later, they issued a press release informing consumers of this fact. The entire incident has demonstrated flaws in the process used by the FDA to approve what it calls “bioequivalent” generic drugs. Because the 150 mg dose of the generic was tested and determined to be the “bioequivalent” of the brand name drug, the 300 mg dose was approved without testing. The drugs are not identical. They are simply concluded to act on the body in the same way. Dosage is naturally a part of the equation in determining how effective a drug will be on a human body.

Thanks to the breakdown in the process regarding generic Wellbutrin XL, the FDA will now require testing of all doses of a generic before granting it approval to be sold to consumers.

Source: Forbes, “A Drug Recall That Should Frighten Us All About The FDA,” by David Maris, 10 October 2012