Jim Adler | The Tough, Smart Lawyer

The U.S. Food and Drug Administration’s mission is to protect public health by regulating America’s drug and food industries. At times this involves issuing FDA warnings about possible risk of products such as pharmaceutical drugs and medical devices.

These warnings may come after the FDA inspects the firms that it regulates. When problems are discovered, the FDA alerts the firm. And if such problems meet a threshold of what’s known as “regulatory significance,” the FDA in addition may issue a warning letter to the firm.

The agency also can issue FDA warnings to physicians and patients in the form of what’s known as a boxed warning, also called a “black box warning.”

Such warnings appear on material inserted in the packaging of some prescription drugs and typically have a border or box surrounding them.

These black box warnings are the most severe warning the FDA makes, indicating that medical studies show that a drug poses a substantial danger of severe and even life-threatening side effects.

As for warnings to firms which produce and sell drugs or medical devices, these FDA warnings tend to signify the first official notification by the FDA that it’s uncovered violations in the Food, Drug and Cosmetic Act. By issuing this FDA warning, the FDA provides the firm with the chance to correct such violations voluntarily. If it does not, formal enforcement actions can be taken by the FDA.

The FDA is not required legally to issue such warnings before it takes enforcement action. Indeed, under some particularly troubling circumstances, the FDA may take immediate enforcement action and forego any type of warning.

The agency also issues “Cyber” warning letters to firms. These are sent by the Internet to websites which provide sales of subscription drugs online — sales which could be illegal. Such cyber warning letters alert these firms that they may be engaged in illegal activities and alerts them to the laws about such matters.

Too, the FDA and the Federal Trade Commission (FTC) may issue a joint warning letter to such firms or others which appear to be breaking federal law.

As for black box warnings in drugs’ packaging, these suggest a form of self-enforcement by a physician or a patient. Such warnings alert prescribers and their patients regarding serious adverse reactions to a drug. They also appear on the FDA’s website, on the sites of drug marketing firms and in the Physicians’ Desk Reference.

Such warnings require physicians to give their patients information regarding relevant risks, though a physician can exercise his or her professional judgment in deciding whether or not to prescribe such a drug.

That’s because physician adherence to black box warnings is entirely voluntary. In fact, there’s no formal system for determining if a physician counseled a patient on the risk or a drug.

Even so, a patient may object to such a prescription, given the information in the black box warning.

Such FDA black box warnings are made after the agency has weighted potentially harmful side effects with potential benefits of a drug. A black box warning also may simply alert physicians and patients to possible drug interactions, as well as dosing and monitoring requirements.

Such warnings are set forth by federal regulations.

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