FDA

FDA Upgrades Policy Surrounding Generics Following Budeprion Issues

Investigations began when patients started taking the generic version of a popular anti-depression drug, Wellbutrin XL. The brand-name drug is available in 150 mg and 300 mg doses. In 2006, Impax Laboratories was granted approval to begin producing the generic version of the drug. The drug was marketed by Teva Pharmaceuticals as Budeprion XL 300 mg.

However, Impax and Teva began to receive reports regarding the 300 mg dose, with patients claiming their depression had returned. These reports of reduced efficacy did not affect the 150 mg version of the drug.

FDADuring the investigation, FDA procedures for approving generic drugs were brought into question. In a letter released during the investigation, the FDA stated that it had approved the 300 mg version of the drug based on data from the 150 mg dosage, meaning the FDA did not perform actual testing on the larger dose.

The issue centers on the long-acting versions of popular drugs. While generics must contain the same active ingredient as their brand name counterparts, other ingredients and delivery methods may vary.

The Federal Drug Administration (FDA) (www.fda.gov) has typically stood behind the off-brand versions of brand-name drugs as being both safe and effective. The FDA’s viewpoint is that generic drugs are equivalent to their brand-name counterparts. Generic drugs have become a large and important sector of the pharmaceutical industry with the majority of drugs prescribed in the United States falling under the generic category.

Though generics have always been available, the high costs of brand-name drugs, and other factors, have caused the use of generics to skyrocket in recent years.

Long-acting, or extended –release, drugs have become popular in recent years because they have fewer dosing requirements. However, the scientific process of creating these drugs to release into the body slowly is complicated. In the case of Budeprion XL 300 mg, the company did not get it right and the FDA oversight was not sufficient to catch the problem.

For consumers, this is a grave situation. In some cases, drug dosage is a matter of life or death and consumers must have confidence that they are in fact receiving the treatment they need.

Because of the issues surrounding the generic version of Wellbutrin, the FDA, in a rare move, has changed its policy regarding generic drugs, specifically extended-release versions of drugs. The FDA will monitor more closely the techniques used by generic drugs makers when producing the extended-release drugs.