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FDA wants generic-drug makers to use same labeling process as brand-name manufacturers


By Jaimy Lee
Posted: November 8, 2013 - 3:30 pm ET
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The Food and Drug Administration is proposing that generic drug manufacturers use the same process as brand-name drugmakers to update product labeling in an announcement made just months after the Supreme Court took up the issue.

The court in June ruled that the FDA doesn't allow generic drug companies to alter the labels of their products with updated safety information unless the brand-name drug manufacturer first does so or unless generic-drug makers undergo a lengthy review process with the agency.

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The way the law currently stands can mean that generic-drug makers are not liable in instances where patients say they were not warned of the risks from certain drugs.

A proposed rule issued Friday would allow generic-drug makers to update product labeling with new safety information before the FDA reviews and approves the change—a process that brand-name pharmaceutical companies follow today.

As a drug becomes more widely used, more information often becomes available about its risks and benefits.

“More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The advocacy group Public Citizen said the FDA's proposal would fill a regulatory gap that has posed a risk to patient safety. The organization in 2011 had petitioned the agency to revise its labeling rules.

“Currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's health research group, and Allison Zieve, director of the Public Citizen litigation group. “The new rule should remedy this public health problem.”

The Generic Pharmaceutical Association expressed concern that multiple versions of safety information would cause confusion for healthcare providers.

“Uniform safety information avoids confusing patients, doctors, pharmacists and nurses and assures all healthcare practitioners that they can rely on consistent information to inform their decisions and patient conversations,” said Ralph Neas, president and CEO of the Generic Pharmaceutical Association.

The FDA also plans to post information online about safety-related changes that have been proposed by generic and brand-name drug companies, noting in the proposal that it's unlikely that healthcare providers would review product labeling for each generic drug that can be substituted for a brand-name medication. This way, patients can look up information about proposed labeling changes.

The Supreme Court this year threw out a jury verdict awarding $21 million to a patient who suffered from skin reactions after taking a generic of the anti-inflammatory drug sulindac that wasn't labeled with a warning for that risk.

The court's majority wrote that it was impossible for the generic maker to comply with a state law requiring it to strengthen the warnings and the federal prohibition against altering the label.

Follow Jaimy Lee on Twitter: @MHjlee


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