Fast Five Quiz: Generic Medications

Mary L. Windle, PharmD

Disclosures

November 22, 2019

The FDA takes reports of therapeutic failures seriously, recognizing that there may be valid issues and concerns over the quality of some generic medications. In such instances, the FDA encourages the generic drug industry to internally investigate these issues.

In its Facts About Generic Drugs resource, the FDA notes that "The Agency [FDA] does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises."

There are experts who feel FDA inspections may not be sufficient to guarantee quality assurance and adherence to Current Good Manufacturing Practices, particularly in overseas manufacturing facilities, some of which are purported to adjust their manufacturing practices on a country-by-country basis. Recent drug recalls on generic formulations of antihypertensive agents have raised further quality concerns with some generic drug manufacturers, particularly those in China and India, where in some instances, plant sterility has been suboptimal and/or bioequivalence data have been fabricated.

Fortunately, the aforementioned quality and safety issues with generic drugs are likely the exception and not the rule. According to the Center for Drug Evaluation and Research, a recent review of 1159 product quality surveys showed an average difference of only 3% between generic drugs and their branded counterparts.

Learn more about the manner in which the FDA responds to reported therapeutic failures.

Access important FDA drug alerts, statements, warning letters, and the FDA Inspection Classification Database.

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