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FDA Considering Changes to Generic Drug Labels

Generic drug labeling may soon undergo a major overhaul. In light of recent reports of the ineffectiveness and dangerous side effects associated with certain generic drugs, the U.S. Food and Drug Administration (FDA) announced last fall that it would be taking a closer look at its labeling requirements for generic drugs. Now, the FDA has announced that it is considering a regulatory change to allow generic drug manufacturers to change their labeling in appropriate circumstances, just as brand-name manufacturers are allowed to do.   The regulatory change is intended to protect the public by making them aware of newly-found risks, side effects, and dangers associated with a particular medication. As this article reported, the FDA seeks to reduce "variability" between the efficacy of name-brand pharmaceuticals and their generic versions. Made with the same active ingredients as name-brand drugs but with different inactive ingredients and delivery mechanisms, generic drugs oftentimes account for approximately 60 percent of a drug's market share by the end of this first year in the market, according to this Bloomberg article.   The inadequacy of generic drug labels has been debated by lawmakers and patient advocates in recent years. In 2012, Democrat congressional lawmakers introduced legislation that would allow generic drug companies to update warning information on their drugs' labels, thereby allowing patients to sue the drug companies for failures to warn about the risks associated with taking their drugs.   Given the controversy surrounding generic drug labels, the U.S. Supreme Court will soon hear a landmark case on generic drug liability.  Mutual Pharmaceutical Co. v. Bartlett involves the appeal of a $21 million judgment awarded to a New Hampshire resident who alleged that she sustained injuries after taking the generic anti-inflammatory drug Sulindac which did not contain adequate labeling. The outcome of this case could potentially impact the ability of consumers to bring product liability lawsuits against drug manufacturers if they are harmed by generic drugs.   Some drug companies and lobbyists worry that changes to drug labeling requirements could lead to increased liability for the manufacturers of generic drugs. Generic drug labels are currently required to duplicate the labels of their brand-name counterparts, which has shielded generic drug manufacturers from liability in failure-to-warn lawsuits. This protection could be lost, however, if the FDA does change regulations to require generic drug manufacturers to modify their labels to accurately reflect new information regarding dangers, risks, and side effects.   The Chicago product liability lawyers at Steinberg, Goodman & Kalish are committed to protecting the public from dangerous products, including unsafe pharmaceutical drugs. If you have been injured by an unsafe drug, whether a generic drug or a brand-name drug, contact the Chicago product liability lawyers at Steinberg, Goodman & Kalish to schedule a free consultation to discuss a possible product liability or medical malpractice claim.         Steinberg Goodman & Kalish  ( is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.


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