FDA Rule Changes
Eight lawmakers, all democrats, (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.)) hammered the Food and Drug Administration over a recent proposal that would require drug and device makers to first get FDA approval before they can update their manufacturer labels with new safety information.
They feel the real 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.
In a summary from FDA Proposes Labeling Rule Change to Codify Long-Standing Position on "Changes Being Effected" Supplements and to Strengthen Federal Preemption Defense in Product Liability Cases
The article states “The Food and Drug Administration (FDA) today published proposed revisions to the agency's drug and medical device labeling regulations, entitled "Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices." 73 Fed.Reg. 2848 (Jan. 16, 2008). The proposed rule limits the circumstances under which a manufacturer may unilaterally change its product labeling via a "changes being effected" (CBE) supplement in advance of the agency's review and approval of those changes. As the law currently stands, there is some uncertainty as to when and under what circumstances a manufacturer may initiate labeling changes under a CBE supplement prior to FDA approval. In the products liability context, plaintiffs have typically argued that manufacturers always have the right (and duty) under existing CBE regulations to make changes that add or strengthen warnings, and that the failure to do so exposes them to tort liability under state law. Manufacturers, on the other hand, have claimed that the FDA's approval of a package insert should preempt claims based on a failure to warn, and that the right to make changes in advance of FDA approval is strictly limited. The FDA's proposed rule, if finalized, clarifies any existing uncertainty and should significantly strengthen a manufacturer's preemption defense.”
These lawmakers believe the 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 agency’s approval. The FDA now allows manufacturers to change their labels to add or strengthen a contraindication, warning and other precautions without waiting for the agency’s approval. Those guidelines are set in the FDA’s “changes being effected” regulations.
But the FDA now says that doing so—“even if done to add new warnings”—undermines its approval process as set out by Congress.
Permitting a sponsor to unilaterally rewrite the labeling for a product following FDA’s approval of a product and its labeling would disrupt FDA’s careful balancing of how the risks and benefits of the product should be communicated.
Who ultimately would benefit from this rule change remains controversial; but these democrats believe it will be the manufacturers.
They feel the real 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.
In a summary from FDA Proposes Labeling Rule Change to Codify Long-Standing Position on "Changes Being Effected" Supplements and to Strengthen Federal Preemption Defense in Product Liability Cases
The article states “The Food and Drug Administration (FDA) today published proposed revisions to the agency's drug and medical device labeling regulations, entitled "Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices." 73 Fed.Reg. 2848 (Jan. 16, 2008). The proposed rule limits the circumstances under which a manufacturer may unilaterally change its product labeling via a "changes being effected" (CBE) supplement in advance of the agency's review and approval of those changes. As the law currently stands, there is some uncertainty as to when and under what circumstances a manufacturer may initiate labeling changes under a CBE supplement prior to FDA approval. In the products liability context, plaintiffs have typically argued that manufacturers always have the right (and duty) under existing CBE regulations to make changes that add or strengthen warnings, and that the failure to do so exposes them to tort liability under state law. Manufacturers, on the other hand, have claimed that the FDA's approval of a package insert should preempt claims based on a failure to warn, and that the right to make changes in advance of FDA approval is strictly limited. The FDA's proposed rule, if finalized, clarifies any existing uncertainty and should significantly strengthen a manufacturer's preemption defense.”
These lawmakers believe the 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 agency’s approval. The FDA now allows manufacturers to change their labels to add or strengthen a contraindication, warning and other precautions without waiting for the agency’s approval. Those guidelines are set in the FDA’s “changes being effected” regulations.
But the FDA now says that doing so—“even if done to add new warnings”—undermines its approval process as set out by Congress.
Permitting a sponsor to unilaterally rewrite the labeling for a product following FDA’s approval of a product and its labeling would disrupt FDA’s careful balancing of how the risks and benefits of the product should be communicated.
Who ultimately would benefit from this rule change remains controversial; but these democrats believe it will be the manufacturers.
Labels: democrats, FDA, legislation
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