For years we've been told that generic drugs are equivalent to brand names in every way that matters. Well, guess what, that's not necessarily so; the Food and Drug Administration (FDA) just pulled a generic for the antidepressant Wellbutrin off pharmacy shelves for not being as effective as the brand name.
The generic is Budeprion XL 300, and concerns over its effectiveness date back to 2007 when patients started complaining of multiple side effects, including headaches, anxiety and insomnia. It took the FDA a while, but eventually it confirmed that Budeprion releases its active ingredient much faster than Wellbutrin. Upon reaching this conclusion, the agency kindly asked Israel-based Teva Pharmaceutical Industries Ltd. to stop selling the drug. Anticipating the Agency's decision, Teva pulled the drug a week before the mandate.
This marks a major shift in thinking about generic vs. brand name pharmaceuticals, and calls into question the "generics are just as good" mantra. As you might imagine, that doesn't sit well with generic Rx manufacturers.
According to CBS News, The Generic Pharmaceutical Association, a trade group for generic drugmakers, moved quickly to defend the track record of both the FDA and its companies.
"There are approximately 10,000 FDA-approved interchangeable generics in the U.S.," said Ralph Neas, the group's CEO and president. "The recall by a single manufacturer of one strength of a generic drug should in no way cast doubt on the impeccable reputation of the generic industry or the FDA."
Maybe not, but the fact that it took five years for the FDA to reach a conclusion that affects hundreds of thousands of people who have been taking Budeprion--under the assumption that it's just as good as Wellbutrin--should raise a few concerns.
David Read, regulatory counsel for the FDA's office of generic drugs, isn't concerned. According to Read, in the last five years the FDA has only had to correct itself on the equivalence of three drugs. Two cases involved drugs from Dr. Reddy's Laboratories: an antidepressant and an antifungal medication. The third case involved an anti-seizure drug from Upshur-Smith Laboratories.
One would have to agree with Read that the percentage of equivalence errors compared to how many drugs are available is minuscule. But, those are the drugs the FDA has confirmed are non-equivalents. The real question is, how many more drugs are sitting on your pharmacy's shelves that don't work as well as the brand name drug? For the moment that's not a question anyone can answer, but the most recent pull of Budeprion should elevate the question to a higher level on the FDA's priority list.
UPDATE: Note that Budeprion XL 300 sold by Teva Pharmaceutical Industries is just one type of generic Wellbutrin equivalent. Other generics are still available.
