Despite What You’ve Heard, Not All Generics Are Alike

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'The FDA requires generic medications to be 'bioequivalent' to their brand counterparts. They do not, however, have rules about what types of inactive ingredients the generics may contain.'

Abby’s current prescription was manufactured by Lupin, a company based in India. For the prior eight years, she took a generic version of the sameThe U.S. has the world’s largest pharmaceutical drug market. The demand for generic drugs has grown substantially in the last few decades, due to a track record of safety, value, and low prices. In the current economic environment, concern about the high price of prescription drugs led the FDA to issue new guidance last month.

Last weekend, I called five pharmacies to find a non-Indian or Chinese-made equivalent for one of my patients. I finally found one who told me they carried an American brand. They were wrong, the product was made in Taiwan. The generic drug industry is facing a continuing problem in India, where many “copycat” medicines are manufactured. Katherine Eban’s excellent book, “Bottle of Lies,” focuses a spotlight on the mostly ignored transgressions of the Indian generic pharmaceutical industry both in the processes they follow or too often do not follow.

To save my patients from paying exorbitant prices for brand medications not covered by insurance, I sometimes prescribe generic alternatives without concern for their safety and efficacy, because the FDA requires generic medications to be “bioequivalent” to their brand counterparts. This means that the generic drug will work the same way and be as safe and effective as the brand-name drug. They do not, however, have rules about what types of inactive ingredients the generics may contain.

What can you do if you suspect your generic medication looks different, and you are experiencing new side effects or a recurrence of your original symptoms after you have been stable for a period of time?

 

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