Drugs

Generic Drug Safety Labeling Legislation

Rep. A. Donald McEachin (D-VA) has introduced the Updated Drug Labeling for Patient Safety Act to direct FDA to allow generic drug manufacturers to update their product labeling with safety-related information. A statement from McEachin says his bill would direct the agency to:

issue a final rule establishing a process allowing generic drug manufacturers to update drug labeling to include new or updated safety-related information and to conform the labeling of each brand name and generic drug product; and
implement the final rule within 180 days of issuance.

McEachin says current FDA regulations require a generic drug to have the same labeling as its branded counterpart with very limited exceptions. “While branded drug manufacturers are permitted to update their product labels to add new safety warnings without prior FDA approval,” he says, “generic manufacturers cannot independently update information for their products, even if they become aware of health risks not represented on their labeling.”

McEachin says the bill is supported by Public Citizen and the American Association for Justice.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome