FDA's Generic Drug Proposal Should Have Consumers Feeling Ill

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April 28, 2015

Just like a bad cold that you can't quite kick, the FDA's proposal to abandon its requirement for generic drugs to carry the same warning labels as their brand-name counterparts is back. And, it should have you feeling ill.

As ILR President Lisa A. Rickard wrote in a 2013 op-ed, "The FDA's proposal writes a prescription for mega lawsuits against generic drug makers by plaintiffs' lawyers alleging that generic labels are somehow inadequate."

In addition, the proposal would force new and unnecessarily burdensome compliance costs on manufacturers of generic medicines. Those compliance costs, added to the costs of increased litigation, would be passed on to consumers.

Generic drugs currently represent a massive cost-savings to Americans. Because these drugs duplicate the effectiveness and the labels of FDA-approved name brand drugs, they are substitutable for the more expensive name brand versions. In 2010 alone, the FDA estimated that generic drugs save American health care consumers about $158 billion.

It was 1984's Hatch-Waxman Act that adopted "sameness" requirements for generic drugs. Meaning that generic drug manufactures didn't need to duplicate the costly research and monitoring systems required of new-to-the-market name brand drugs.

Since the enactment of that law, the FDA has interpreted it to prohibit generic drug manufacturers from using labels different from the name brand equivalent. That interpretation was affirmed by the U.S. Supreme Court in two cases - PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett - in which the court found that generic manufacturers must replicate FDA-approved brand name labels.

Some in the plaintiffs bar, however, don't like the clarity provided by the law, and the court's decisions, because it makes it harder to pursue litigation against generic drug manufacturers.

In comments filed this week with the FDA, ILR is asking the FDA to institute an "Expedited Agency Review" process and approve all changes to drugs' labels. As our comments explain, ensuring that the FDA has final say on labels will "facilitate the swift update of prescription drug labels upon the availability of new safety information, while eliminating the potential for confusion created by simultaneous use of multiple labels for the same drug." An expedited review process would also ensure that patients and healthcare professionals receive accurate and timely safety information.

The only ones who would benefit from such confusion would be the plaintiffs' bar. And patients who rely on affordable generic medicines would pay the price.

You can read the full comments we submitted to the FDA here.