Life Science Compliance Update

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November 25, 2013

FDA: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

The Food and Drug Administration (FDA) wants to cut down the time it takes patients and doctors to get new safety information about generic drugs. A draft of the regulation was unveiled in early November. It addresses a discrepancy in drug labeling rules that lawmakers and safety advocates have warned could be putting patients at risk.

According to a story from Regwatch: "Under the agency's proposed regulation, generic pharmaceutical manufacturers would be able to update safety labels on their own, without FDA review. Currently, they need to wait until the corresponding brand name drug gets approval first. Brand name drugs, however, can update their labels on their own, and get FDA approval after the changes are already made."

Janet Woodcock, M.D., the director of FDA's Center for Drug Evaluation and Research, released a statement through the FDA's blog. She writes: "FDA is issuing a proposed rule that would allow generic drug manufacturers to independently update and promptly distribute revised product labeling — just like brand name manufacturers – before FDA reviews or approves the change.

Empowering generic drug companies to update their own drug safety information is intended to provide them the incentive to more actively participate with FDA in ensuring the timeliness, accuracy, and completeness of this information.

The brand manufacturer would be expected to consider the information provided by the generic drug manufacturer as part of its review and evaluation of adverse drug experience information for its drug.

And to make sure that the drug safety information updates from both generic and brand name companies are readily available to health care professionals and the public, FDA plans to post these updates on its website.

Faster safety updates and easier access to this information should be a win–win for all involved."

However, this regulation has received strong opposition from the U.S. Chamber of Commerce. In a release, Lisa A. Rickard, president of the U.S. Chamber Institute for Legal Reform (ILR), argued the regulation would cause confusion and drive up drug costs for consumers:

"The FDA's proposal writes a prescription for mega lawsuits against generic drug makers by plaintiffs' lawyers alleging that generic labels are somehow inadequate.

The proposed change would make warning labels inconsistent and confusing for consumers. It would also force generic manufacturers to conduct costly research and create a structure to assess their labels, which would in turn lead to higher drug costs.

It is unfortunate that the FDA is considering a change that could drive up the cost of generic drugs, perhaps by billions of dollars."

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