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FDA Creates Liability with Labeling Change

The FDA is in the process of revising labeling requirements for drugs and medical devices. The language has been inserted in a nearly 20-page document regarding regulations related to tobacco, drugs, and medical devices. If adopted by Congress, it would relax labeling requirements currently imposed on pharmaceutical companies and makers of medical devices.


The American Medical Association estimates that off-label use of drugs and medical devices ranges between 10 and 20 percent. Under current regulations, physicians are allowed to prescribe these drugs and devices if they feel the usage will benefit the patient. The AMA strongly supports this practice as they argue it gives physicians greater latitude in developing treatment regimens for patients.

"Should the new rules be adopted, it will make it easier for companies to avoid liability for the injuries their products may cause. These changes will make it riskier to take everything from over-the-counter medication to the medicines and medical devices their physician may prescribe," commented Tennessee product liability attorney Tony Seaton.

However, physicians are not required to notify patients that the medications or devices they are prescribing are being used for off-label purposes. In many cases, the only way a patient will know this is for them to read the fine print on the medication or device itself. If the language is not there, patients will have no idea. Thus, this rule change will put patient health and safety at risk, and remove their ability to make an informed decision about their healthcare.

"The FDA has attempted to sneak this rule change past the public. It was hidden within a non-germane document and not discovered until after the period for public comment had passed. As such, it's now in the hands of Congress to decide whether this new rule is adopted," remarked product liability attorney Tony Seaton.

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