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FDA Report Disappoints

FDA Report Disappoints

Melinda Beck of the Wall Street Journal has written about the generic drug controversy. You can read it at: Health Journal.

Years ago, we loved generic drugs and encouraged patients to request that their doctors prescribe generically whenever possible. The savings were phenomenal, even 20 years ago.

 The savings are even better today. A $4 generic prescription for a 30-day supply of fluoxetine at a discount pharmacy chain is certainly much cheaper than a month’s worth of Prozac, which can cost as much as $175.

The only problem with this otherwise rosy picture is that everything depends upon the FDA’s vigilance to ensure that all generic drugs are indeed identical to their brand-name counterparts. Over the last several years, we have begun to doubt the government’s ability to do this job adequately.

Put aside for a moment the whole issue of medications imported from countries like China and India. The heparin horror highlights questions about how well such ingredients are monitored for quality control.

We thought that the FDA required every generic drug to be tested for equivalence before it could be approved and sold. Now that the FDA has published the report of its investigation, we know that is not the case. Budeprion XL 300 (a generic formulation of bupropion, meant as a substitute for Wellbutrin XL 300) was not subjected to bioequivalence testing. Instead, the FDA allowed the company to submit data for a pill containing half the dose (Budeprion XL 150).

Although the FDA says Budeprion XL 300 is good enough, its own report regarding the time to maximum blood levels (Tmax) suggests that the 150 mg pill behaves differently in the body: “The bupropion Tmax was faster for Teva’s XL product (2-3 hours) than Wellbutrin XL (5-6 hours).”

This could account for the experiences people have described on this Web site about side effects and depression, such as this one from BK:

“In March of 2007, my insurance company switched my Wellbutrin XL 300 to the generic-Budeprion. Within six weeks, my depression had returned full force.

“In May, my doctor put me back on Wellbutrin and within 2 to 3 weeks, I was fine again.

“Obviously, in my case and in many others, Budeprion does not work. In many cases, [people report] it has even done harm.”

Melinda Beck of the Wall Street Journal has summarized the controversy extremely well. You can read it at: Health Journal.

 This is a demonstration of how e-patients can inform each other and influence policy.

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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.” .
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