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Are Generic Drug Manufacturers Moving Too Slowly to Updated Safety Info?

MedicationsThe United States Supreme Court is being asked to answer this question by Teva Pharmaceuticals and other makers of the generic version of the drug Fosamax. The name-brand drug, Fosamax, manufactured by Merck, and its generic counter parts, are used in the treatment of osteoporosis.

Merck updated the labeling on Fosamax in 2010, and again in 2011, to warn about the risk of femur fracture associated with the use of the drug. It was not until six weeks after each of these updates that Teva and others made the comparable changes to the labels on the drug’s generic versions, according to documents filed in a lawsuit by Ms. Olga Pikerie of California.

For Ms. Pikerie, who was taking the generic version of Fosamax, this six-week delay was too long. According to court documents, Ms. Pikerie stood up from a park bench and suffered a femur fracture after Merck had already changed the labeling on the name-brand drug to warn about the risk of femur fracture and the warning signs of impending femur fracture. However, the makers of the generic version of Fosamax had not yet made the corresponding changes to their generic drugs and had not communicated the new warnings to Ms. Pikerie’s doctors.

Mrs. Pikerie’s lawsuit alleges that even aside from actually updating the labels, physicians could have been quickly alerted about the new warnings with the use of a “Dear Doctor letter,” which is a standard notice that is routinely sent out to doctors by drug manufacturers to alert them to product updates. But the defendants here did not send such letters to doctors.

Teva and the other defendants claim that they cannot always quickly update safety labeling information and, further contend that they could not send notice letters to doctors without the name-brand manufacturer doing so first. They assert that sending a “Dear Doctor letter” amounts to labeling.

In a 2011 decision, the U.S. Supreme Court ruled that generic drug makers cannot add new side effect information to drug labels independently under FDA regulations, and consequently, they should not be liable for a failure to warn against any risks. Ultimately, the Court held that generic drug makers cannot make labeling changes until after the brand-name drug maker acts to make such changes.

In Ms. Pikerie’s case, Merck had already made the labeling changes to Fosamax at the time that she suffered her injuries. Thus, at that time, the generic drug makers were obligated to make the appropriate changes to the labels on the generic version of their drugs. Last year, an appellate court in California sided with Ms. Pikerie, refusing to dismiss her claims against Teva and the others, which has prompted Teva to seek relief from the U.S. Supreme Court.

Meanwhile, proposed changes to the FDA’s labeling regulations may render this whole issue moot in the near future. The FDA has issued a proposal that would revise its regulations by requiring a generic drug manufacturer to add new safety warnings to its generic labels without prior approval from the FDA. Generic and brand-name drug manufacturers would then be on equal footing as far as labeling requirements are concerned.



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