Go Ad-Free
logoThe People's Perspective on Medicine

Generic Drug Controversy Won’t Quit!

In identifying a generic drug as "identical" to its brand-name counterpart, the FDA actually permits a number of differences.

The FDA maintains that all generic drugs are “identical” to their brand name counterparts. Of course, the word identical does not mean the same thing to everyone. Most of us assume that identical means exactly the same. For example, identical twins have the same exact DNA. If you drop your iPhone down the toilet and want to replace it with an “identical” iPhone, you can be confident that your new iPhone is exactly the same as the old one.

“Identical” Is Different for Drugs

The FDA, however, has a different definition for identical, especially when it refers to generic drugs: “A generic drug is identical–or bioequivalent–to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

What the FDA does not tell you in this sentence is that generic drugs can have different “inert” ingredients or fillers. In other words, all the other stuff except the active ingredient could be completely different. What’s more, the formulation can be be quite different. Take Wellbutrin XL 300, for example. This brand name antidepressant gradually releases the active ingredient bupropion over the course of a day. It uses a “membrane” technology for this slow release.

Budeprion XL 300

One generic equivalent, Budeprion XL 300, uses a “matrix” technology for its slow release. The same amount of bupropion (300 mg) is released, but the timing is quite different. Budeprion XL dissolves and releases its ingredient more quickly. The FDA confirms this in a report it has released on its Web site.

We have received hundreds of complaints about Budeprion XL 300 not behaving like the brand name Wellbutrin XL 300. In an unprecedented response to these concerns, the FDA and the manufacturer and distributor of Budeprion are planning a study. Perhaps we will learn if the two formulations are indeed “identical” or not. It will take time, however, to collect and analyze the data.

Update: When the FDA completed its study, it found that in fact Budeprion XL 300 was not identical to Wellbutrin XL 300. Read our story about it here.

Questions about Other Generic Drugs

Budeprion XL 300 is not the only generic drug raising questions. Over the last several years we have received hundreds and hundreds of complaints about a variety of generic drugs. They range from the generic form of the anti-seizure drug Keppra (levetiracetam) to the heart drug Toprol XL (metoprolol succinate), the heartburn medicine Prilosec (omeprazole) and the pain reliever OxyContin (oxycodone).

If you would like to report a problem with a generic drug, either side effects or lack of effectiveness, please add your comment below. Put the brand or generic drug name at the top of your comment. We will forward your story to the FDA.

Rate this article
star-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-empty
4.5- 13 ratings
About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
Tired of the ads on our website?

Now you can browse our website completely ad-free for just $5 / month. Stay up to date on breaking health news and support our work without the distraction of advertisements.

Browse our website ad-free
Join over 150,000 Subscribers at The People's Pharmacy

We're empowering you to make wise decisions about your own health, by providing you with essential health information about both medical and alternative treatment options.