Is FDA approval a bar to a product liability claim?

The growth of the pharmaceutical industry seems unabated; with new prescription drugs released every year. Yet the side effects that often accompany the marketing and packaging labels of prescription drugs may raise safety concerns among some consumers.

Even more troubling is the news that a significant safeguard against dangerous drugs, the U.S. Food and Drug Administration's new drug approval process, may not be what it once was. Since 2009, the approval time for new drugs has been cut in half, dropping from 21 to a mere 10 months. 

Some medications, like cancer drugs, may be deserving of expedited review because of the deadly diseases they are intended to treat. Yet is it wise to shorten the review time for all categories of prescription drugs? It’s unclear whether the faster approvals are the result of more efficient administrative processes, or perhaps less stringent standards. 

Given the number of revised approvals or even recalls that the FDA issues every year, it seems that new drugs should still be approached with caution. Unfortunately, it often requires patient injuries before a drug maker’s product is pulled from the market, or the scope of its approval is narrowed. 

Like the manufacturers of other products that don’t perform according to their advertised function, drug makers may also face civil liability for dangerous drugs. Our law firm has experience helping clients bring product liability claims against a variety of manufacturers and companies. Although a civil lawsuit may not be the first thing on a patient’s mind, it is important to hold drug makers accountable for their products. Doing so may even help avoid similar injuries to other patients.

Source: MedCity News, “Infographic: FDA has drastically cut down drug approval times,” Meghana Keshavan, March 29, 2016

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