Generic medications are inherently good because they offer the same basic mechanisms of action of a particular brand-name drug at a greatly reduced price — when they are well made, well-tested, and well regulated. But in the U.S., such concerns are starting to build that generics aren’t always as well made, not nearly as well tested, and perhaps not very well regulated.

Back in October, we blogged how spontaneous reports to The People’s Pharmacy newspaper column led them to conduct an independent analysis on a form of generic Wellbutrin. The report showed significant differences in how the generic form of the drug was released into a person’s bloodstream.

Now, the Los Angeles Times weighs in on the debate, with their story, Generics: Just as good?. The reporter notes:

The American Assn. of Clinical Endocrinologists, the Endocrine Society and the American Thyroid Assn. joined voices in 2004 to warn that patients with hypothyroidism could be harmed by switching among the many generics used to treat the condition. And physicians who care for organ transplant recipients have opposed generic substitution of immunosupressant drugs for their patients without a transplant specialist’s prior approval. Societies that represent these doctors have been active in seeking state laws that would limit such switches.

Generic manufacturers, through their trade association, swear the drugs are the same (they technically have to be), but independent testing shows otherwise. The FDA has few regulations or testing in place, outside some simple lab data and “bioequivalence” testing in about 24 to 36 healthy volunteers showing that the drug appears in the bloodstream in a similar manner to the brand name drug. So after you’ve done your successful trial on 24 people, you’re done and you can now market the drug to millions.

The article notes that 500 new generic drugs come on the market now every year. It’s time for the FDA to step up and take a more proactive stance and review of these generics and their approval process for them. People seem to have certain negative affects with certain types of generics that require greater study and attention.

Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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    Last reviewed: By John M. Grohol, Psy.D. on 17 Mar 2008
    Published on PsychCentral.com. All rights reserved.