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Heads up on generic drugs

Sunday, November 4, 2012
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This page has long supported the substitution of generic drugs for name-brand medicine as a way to curb health costs. Our support has been based on the supposition — made by the government — that the active ingredients in generics were identical in quantity and quality to costlier name-brand drugs, and thus produce identical results. But the situation appears to have changed with the development of so-called extended-release medicines, and the government is reportedly taking a closer look. One appears to be justified.

The issue is not with the active ingredients but the inert fillers used in these drugs, some of which are designed to gradually release the drugs inside a person’s body. Those used by generic manufacturers aren’t necessarily the same as in name-brand drugs, and in the case of at least one it had fielded numerous complaints about — a generic version of the popular antidepressant Wellbutrin XL — the Food and Drug Administration conducted a study and concluded that it did not perform as well.

As a result, the drug’s manufacturer has stopped selling the extended-release version of the medicine, and the FDA is looking more closely at how the generic versions of such drugs are made and who well they work.

A New York Times report indicates that when the FDA approved a generic version of this extended-release drug, it didn’t bother requiring a direct study in patients, but extrapolated results from the manufacturer’s study on its regular-dose version of the drug. This appears to have been a mistake, as the inert ingredients which act as delivery systems for these extended-release drugs obviously make some difference.

Given the widespread use of generics, it may be time for the FDA to revisit the role of all of the drugs’ inert fillers because consumer complaints about their efficacy have not been confined just to their extended-release versions.

 
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