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FDA to Scrutinize Generic Drug Manufacturers More Closely

Written by Ankin Law Office

The U.S. Food and Drug Administration (FDA) may soon be scrutinizing generic drug manufacturers more closely, particularly the makers of extended-release drugs. The FDA’s action comes on the heels of reports of the ineffectiveness of the generic version of Wellbutrin, a popular antidepressant.

Complaints about the generic version of Wellbutrin, which is manufactured by Impax Laboratories and marketed by Teva, began surfacing shortly after it was introduced in 2006, according to this New York Times article. The complaints included reports that patients who switched from Wellbutrin to a comparable dose of the generic version saw the of depression symptoms.

According to this article, the FDA’s Center for Drug Evaluation and Research has said that the FDA is considering enacting stricter standards for how similar generic drugs would have to be to the original drugs. The goal of the FDA’s action is to reduce “variability” between the efficacy of name-brand pharmaceuticals and their generic versions.

Generic drugs are those pharmaceuticals that are made with the same active ingredient as branded medications, but may have different inactive ingredients and delivery mechanisms. Generic drugs can cost 80 to 85 percent less than the brand name drug they duplicate.

Brand-name drugs stay on the market an average of 12.8 years before generic versions enter the market. Oftentimes, generic versions account for nearly 60 percent of the market share by the end of their first year in the market, according to a Bloomberg article.

Bloomberg reports that patients have also complained about generic anti-seizure drugs not working as well as the name brand version, as well. The use of generic nervous-system medicines, such as anti-seizure drugs, generated $250 billion in health care savings from 1999 to 2008.

Although Janet Woodcock, direction of the FDA Center for Drug Evaluation and Research, cited concerns with generic drugs, she did not specify when the FDA would come to any conclusions about standards of equivalence for generic pharmaceutical drugs. The FDA currently allows generic drugs to absorb at a 25 percent different rate and extent than the brand name drugs they duplicate.

Earlier this year, Democrat congressional lawmakers introduced legislation that would allow generic drug companies to update warning information on their drugs’ labels, thereby allowing patients to sue the drug companies for failures to warn about the risks associated with taking their drugs.

Drug manufacturers, including manufacturers of generic drugs, have an obligation to ensure that the drugs they are manufacturing are safe, effective, and marketed accurately. When a drug manufacturer provides an unsafe drug or an ineffective drug, the drug manufacturer may be liable for any resulting injuries in a personal injury or product liability lawsuit. Contact the skilled Chicago unsafe pharmaceutical law firm of Ankin Law Offices, LLC at (312) 600-0000 if you would like to learn more about unsafe drug liability.

Categories: Product Liability