If this post doesn’t spell out how truly incompetent the Food and Drug Administration is, nothing will. Last week, the FDA recalled the 300mg generic version of Wellbutrin XL. Why? Because it simply doesn’t work. What’s worse (but not surprising) is that the problem with this drug has been around for several years but the FDA chose to ignore it.
As is the case with many other generic drugs, the FDA approved this one with no testing whatsoever. The generic version of Wellbutrin XL comes in 150mg and 300mg doses. Apparently the 150mg dose works just fine. So keeping in line with their lackadaisical attitude toward consumer safety, the FDA made the assumption that if one dose works, the other obviously will too. The 300mg dose is prescribed for patients who have severe depression and anxiety. It was released on the market in 2006. Shortly thereafter, the FDA began receiving numerous complaints from patients.
The FDA is supposed to approve drugs based on its own studies. Instead, it often relies on manufacturers for this task. In this particular instance, Teva, the marketer of the drug which is manufactured by Impax Laboratories, was instructed to do the trial and didn’t, claiming “slow patient enrollment” as the reason. So in 2010, four years after approving the generic, the FDA did its own study which was completed last year. The study concluded that the 300mg dose of the generic version of Wellbutrin XL is ineffective because it doesn’t deliver enough of the drug.
The organization’s press release stated that “FDA has approved five generic versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product. FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300 mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the Agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.” The wording of the above implies that it WAS appropriate to make assumptions regarding generic drugs’ effectiveness, but is no longer. Not only was it totally inappropriate, it is appalling.
Antidepressants are normally prescribed at the minimum dosage and “ramped up” gradually to a higher dose. Imagine the repercussions for patients who took the 300mg dose. Many of these people have Major Depressive Disorder and experience severe symptoms of depression, including suicidal ideation. So one can only speculate that they felt not only disappointment, but complete despair when the 300mg dose made them feel no better or their symptoms continued to escalate.
Big Pharma and the FDA can’t continue with their current practices without serious backlash. Hopefully members of Congress will soon understand that if they don’t force regulation and oversight, their own careers may be in jeopardy as one day, the general public will no longer stand for allowing drug companies and the FDA to play Russian Roulette with their health.