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FDA Proposes A Change to Generic Drug Labeling

Posted by Joseph F. Sullivan | Nov 19, 2013 | 0 Comments

Federal regulators have just issued a proposed rule change that would enable the makers of generic drugs to update drug labels when they receive safety information related to their medications. Under current regulations, this is restricted for generic drug makers, who must ensure their labels contain the same information as the related brand version.

Approval of the U.S. Food and Drug Administration (FDA) proposed rule would allow for product liability lawsuits to proceed against the makers of generic medications, according to The New York Times. For example, in one recent case, a woman allegedly suffered from serious neurological effects following treatment with generic acid reflux medication, metoclopramide. She stopped taking the drug in 2009, after five years, when the FDA issued a warning about long-term use of the medication associated with the neurological disorder, tardive dyskinesia, according to NBC Today News.

The woman attempted to sue the generic drug maker, describing the warning label as "misleading" and "inadequate," NBC Today News reported. The court dismissed the case, citing a 2011 Supreme Court ruling in which it was found that generic drug makers cannot be sued. Under prevailing FDA rules, only the brand name drug manufacturers are responsible for drug safety warnings, generic drug makers simply need to copy the brand label and have no control over verbiage. Because of this, they can also not be held liable, NBC Today News reported.

In other words, under current law, patients do not have the same rights against generic drug makers as they do against brand name drug makers. Under the new FDA proposal, that would change. The rule would enable generic drug makers to update their labels based on new information in the same way that brand manufacturers are able to. The proposal would result in potential liability for generic drug makers and require them to update drug labels on a timelier basis, according to NBC Today News.

More than two years ago, a watchdog group, Public Citizen, petitioned the agency to close what it described as a dangerous safety gap. "Ultimately, we believe that the generic companies need to be the ones who are primarily responsible for ensuring the safety of their products," Dr. Michael Carome of Public Citizen told NBC Today News. "Right now, no one's doing it adequately." More than 80 percent of the prescriptions filled in the United States are filled generically.

The FDA explained that today, "generic manufacturers must wait to update product safety information until the corresponding brand name product has received approval to update its safety information. Brand drug manufacturers are allowed to independently update and promptly distribute updated safety information by submitting a 'changes being effected' (CBE-0) supplement to FDA." In the case of generic drug makers, they are required to "notify the FDA of new safety information, and wait for the FDA and the brand manufacturer to determine the updated labeling, which may result in a delay in getting new information to health care professionals and patients."

Janet Woodcock, M.D., director of the FDA'S Center for Drug Evaluation and Research, stated that "This proposal will help ensure that health-care professionals and consumers have access to the latest safety information for medications they use."

The Generic Pharmaceutical Association asserts generics are as safe as the brands, telling NBC Today News that "patient safety is the foremost concern" and that a change in rules would create "unnecessary confusion" and "could drive up costs."

The FDA proposal will go through a public comment period before being finalized. In the meantime, the agency stated that it would be creating a web page on which safety-related drug maker changes would be available.


  • NBC Today News; FDA Moves to Make Generic Drug Makers More Accountable; by Jeff Rossen and Avni Patel; November 8, 2013;
  • The New York Times; Label Updates May Be Allowed for Generics; by Katie Thomas; November 8, 2013;
  • The U.S. Food and Drug Administration; FDA takes action to speed safety information updates on generic drugs; November 8, 2013;
  • The Federal Register; Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; November 13, 2013;

About the Author

Joseph F. Sullivan

Born in Jamaica, Queens to working class parents, Joseph Sullivan became the second member of his family to attend college and the first to obtain an advanced degree. He graduated cum laude from Temple University School of Law. While there, he was a writer and editor of the Temple Law Review. ...


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