On March 27, 2014, the New York Times published an editorial in support of a proposed change to the U.S. Food and Drug Administration’s (FDA) rules governing labeling of generic drugs. The editorial acknowledged that the FDA had proposed changes that would permit a generic drug manufacturer to change the warnings provided for the generic drug. Currently, FDA regulations require the label for a generic drug to be the same as the label for the brand-name drug.
Under the current regulations and court interpretations of those regulations, a consumer harmed by a generic drug cannot recover for failure to warn of new dangers, while a consumer harmed by a brand name drug can recover from the brand name manufacturer. The editorial recognized that the use of generic drugs has soared in recent years and 80 percent of prescriptions are now filled with generic drugs instead of brand name drugs. Once a generic drug comes on the market, brand name drug use diminishes and the brand name manufacturer does not have an incentive to warn of new dangers.
On April 1, 2014, the Subcommittee on Health in Congress held a hearing on the proposed rule change. During the hearing, Janet Woodcock, M.D., who is director of the Center for Drug Evaluation and Research (CDER) with the FDA, testified concerning the effect of the proposed rule change but noted that the proposed changes were not final. She noted that the current state of the law “alters the incentives for generic drug manufacturers to comply with current requirements to conduct robust post-marketing surveillance, evaluation, and reporting, and to ensure that the labeling for their drugs is accurate and up to date.” Ms. Woodcock testified that the proposed rule change “is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.” At press time for this issue, a final rule has not yet been adopted.
If you need more information on this subject, contact James Lampkin, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at James.Lampkin@beasleyallen.com.
Source: New York Times
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