FDA altering stance on generic prescription drugs

The Food and Drug Administration is altering its stance on the safety and efficacy of generic prescription drugs after problems arose with a popular, extended-release generic antidepressant drug.

According to a New York Times report, problems with the 300-milligram dose of bupropion have prompted health officials to look at how they oversee the production of generic drugs. Bupropion is a generic form of the antidepressant drug Wellbutrin XL. Complications reported to the FDA were limited to the specific 300-milligram, extended-release dosage of the drug. People taking the generic form of the antidepressant complained that their depression had returned after they had switched from the name-brand version of the pill to the generic.

The FDA maintains that generic prescription drugs are just as safe and effective as their name-brand alternatives. This thinking has led to a majority of all prescriptions filled in the U.S. to be done so with generic forms of drugs. After receiving so many reports of complications associated with bupropion, the FDA is changing that thinking, at least somewhat.

Bupropion is manufactured and marketed by two companies in the U.S., Impax and Teva Pharmaceuticals, and the pair have stopped manufacturing the drug after numerous reports of adverse events linked to the extended-release form of the antidepressant were submitted to the FDA.

Extended-release prescription drugs are formulated so the Active Ingredient in the dose is released slowly over time. Manufacturing these drugs is different than the process used to formulate regular prescription drugs.

Advocates for generic prescription drugs believe the FDA is joining others who believe their version of a prescription medication is not as effective as the name-brand alternative. Some believe the problems with bupropion are limited to this drug in particular but others believe the problems extend to all extended-release generic drugs.

The amount of these drugs on the market has expanded considerably in a short amount of time. Just more than a decade ago, in 2001, there were 84 extended-release generic drugs available on the market. Last year, that number had grown to 120.

Companies that manufacture extended-release generic drugs are attempting to mimic the way a name-brand alternative releases the drug over a long period of time. The methods to produce these drugs are covered by patents and in some cases, as the New York Times reports, the methods used by the manufacturers of the branded drug have patents that last longer than the patents on the drug. This allows generic manufacturers to explore their own means of creating their version of an  extended-release form of that drug.

The problems with bupropion suggest that some generic  manufacturers are not always successful at mimicking the way the name-brand drug performs that function and that could be putting more and more people at risk as the popularity of the generic drugs grows.

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