government
AMA backs drug labeling improvement act
NEWS IN BRIEF — Posted Sept. 17, 2012
The American Medical Association in an Aug. 29 letter to Rep. Chris Van Hollen (D, Md.) expressed support for the lawmaker’s bill to ensure that all prescription drugs, including generics, have updated warnings and accurate information on their labels.
Doctors without resources to survey the safety of every drug they use rely on manufacturers to provide medicines that are safe and effective, subject to the Food and Drug Administration’s oversight and approval, wrote James L. Madara, MD, AMA executive vice president and CEO. Van Hollen is the lead Democrat on the House Budget Committee.
“Unfortunately, the fundamental notion that manufacturers have an ongoing duty to ensure the accuracy of their drug labeling has been undermined by a recent judicial holding that generic manufacturers do not bear this basic responsibility,” Dr. Madara wrote.
The U.S Supreme Court ruled in June 2011 that generic drugmakers are not liable for labeling errors made by brand-name companies that manufactured the original version of the medications. Federal law requires that generic labels match only those of brand-name labels and need not include additional warnings or updates, according to the decision.
Van Hollen’s bill would give generic drugmakers the authority to change their labels using the same procedures as brand-name drugmakers. This would allow them to be held accountable for monitoring the safety of their products, Dr. Madara wrote. “When a physician now prescribes a generic alternative to a brand drug, neither the physician nor the patient may assume that the label accurately reflects new risks known to the generic manufacturer.”
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/09/17/gvbf0917.htm.
