Generic Drug Law Update -- November 2012: New Bill Seeks to Expand Manufacturers Post-Sale Pharmacovigilance Duties

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[author: Kelly Savage Day]

Democratic legislators in both houses of Congress introduced legislation that seeks to reverse the U.S. Supreme Court’s recent decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which bars state law tort suits against generic manufacturers on preemption grounds because federal law prohibits manufacturers of generic drugs from providing safety warnings to the public via its product labeling that differ from those provided on the brand-name equivalent’s labeling.  Under the Senate’s Patient Safety and Generic Labeling Improvement Act, S. 2295 Senate Bill,  and the House of Representatives' Patient Safety and Drug Labeling Improvement Act, H.R. 4384, the House Bill, generic manufacturers would be required to revise their labeling using the same processes currently available to brand-name manufacturers to strengthen the warnings on their labels or face tort liability for failing to do so.

In a letter to the Senate, 41 Attorney Generals (AGs) urged Congress to adopt the legislation. “Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic versions are now denied this protection. Congress can readily cure this problem by amending federal law.”  The 41 state and territorial AGs who signed onto the letter include:  Louisiana, Minnesota, Vermont, American Samoa, Arizona, Arkansas, California, Colorado, Delaware, Washington, D.C., Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Northern Mariana Islands, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Washington, West Virginia and Wisconsin.

While we believe that the passage of this legislation is extremely unlikely, if passed, the legislation will fundamentally change the way generic companies must do business in the future.  As of today, no counter-legislation has been proposed.  But that could change. Just two years ago, Republican Sen. John Cornyn of Texas filed an amendment to pending legislation that, if enacted, would have preempted tort suits against generic drug manufacturers.

A more likely scenario after President Obama’s recent victory would be for the FDA to change its regulations so that generic manufacturers can add new warnings to their products in an attempt to undo the court’s preemption decision.

We will continue to monitor legislative developments and update the alert should any further actions occur.