FDA's Generic-Drug Label Rule Draws Controversy

When new evidence emerges that a brand-name prescription drug has harmed patients, manufacturers are required to immediately warn doctors and consumers by updating product labels or sending letters.

When new evidence emerges that a brand-name prescription drug has harmed patients, manufacturers are required to immediately warn doctors and consumers by updating product labels or sending letters.

Drugmakers face major product liability exposure under the “failure to warn” legal theory if they fail to act quickly. That gives them a strong incentive to take prompt steps to protect patient safety.

The federal mandate to update warning labels, however, doesn't apply to the 3.4 billion prescriptions for generic drugs ordered annually in the U.S. In fact, it's just the opposite.

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Source: Modern Healthcare