Eight influential lawmakers hammered the Food and Drug Administration over a Jan. 16 proposed rule that would require drug and device makers to first get FDA approval before they can update their manufacturer labels with new safety information.
We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe, the lawmakers said in a letter sent to FDA Commissioner Andrew von Eschenbach. Such a policy change comes at the expense of consumers and violates the mission of the FDA.
The proposal amends current regulations that allow a company to quickly update their drug and device labels without the agencys approval. The FDA now allows manufacturers to change their labels to add or strengthen a contraindication, warning and other precautions without waiting for the agencys approval. Those guidelines are set in the FDAs changes being effected regulations.
But the FDA now says that doing soeven if done to add new warningsundermines its approval process as set out by Congress.
Indeed, permitting a sponsor to unilaterally rewrite the labeling for a product following FDAs approval of a product and its labeling would disrupt FDAs careful balancing of how the risks and benefits of the product should be communicated, the FDA said it in its proposed rule.
The letter, sent Jan. 23, was signed by Sens. Christopher Dodd (D-Conn.), Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) and in the House by Reps. John Dingell (D-Mich.), Rosa DeLauro (D-Conn.), Edward Markey (D-Mass.) Frank Pallone Jr. (D-N.J.) and Henry Waxman (D-N.Y.). -- by Matthew DoBias
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