FDA's proposed generic drug labeling changes come under fire

The U.S. Chamber of Commerce's Institute for Legal Reform (ILR) is opposing the U.S. Food and Drug Administration's latest attempt to pass legislation making it unnecessary for generic drugs to be labeled with the same warnings as brand-name equivalents.

Officials from the ILR pointed out that compliance costs and the increased litigation that would likely result would mean increased costs for generic drug consumers.

Generic drugs have made it possible for Americans to save significantly on prescriptions. In 2010, the FDA estimated American health care consumers saved approximately $158 billion by buying generic drugs instead of their brand-name counterparts.

In a 2013 op-ed piece published in a variety of newspapers, ILR President Lisa A. Rickard said legislation to take warning labels off the generic drugs was "a prescription for mega lawsuits against generic drug makers by plaintiffs' lawyers alleging that generic labels are somehow inadequate."

Earlier this week, ILR representatives submitted an extensive letter to the FDA, detailing their objections to the agency's latest proposal and calling for an "expedited agency review" process to "ensure that patients and health care professionals receive accurate and timely safety information."

"The only ones who would benefit from such confusion would be the plaintiffs’ bar," ILR representatives said. "And patients who rely on affordable generic medicines would pay the price."

The comments submitted to the FDA by the ILR can be found at http://www.instituteforlegalreform.com/uploads/sites/1/373081566_v_1_ILR_FDA_Comment_Supplement_Lett....
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