The FDA’s New Proposed Generic Drug Rule

American Constitution Society Blog
Friday, February 28, 2014

by Joanne Doroshow, Executive Director, Center for Justice & Democracy at New York Law School

Today, it’s far more likely than not that a pharmacist will fill a prescription with a drug’s generic version. According to the FDA, “approximately 80 percent of drugs dispensed today are generic.”

Most people take generic drugs without ever thinking about their safety, or their legal options should they be harmed. That was certainly the case with New Hampshire resident Karen Bartlett, who in 2004 was prescribed a generic version of the drug sulindac for shoulder pain. The New York Times described what happened next to Bartlett:
“Within weeks of taking the drug, her skin began to slough off until nearly two-thirds of it was gone. She spent almost two months in a burn unit, and months more in a medically induced coma. The reaction permanently damaged her lungs and esophagus and rendered her legally blind.”
Bartlett sued the drug company, claiming there was a design-defect with the drug. A jury awarded her $21 million in damages. But in the 2013 U.S. Supreme Court case Mutual Pharmaceutical Co. v. Bartlett, the Court overturned the verdict. In a 5-4 decision, the Court reasoned that because generic drug companies have a responsibility to mimic the composition of their brand-name counterparts and cannot independently alter their drugs’ composition, they cannot be sued for design-defect claims.
The Bartlett case was the second generic drug liability case to reach the Court in recent years.  In 2011, in PLIVA, Inc. v. Mensing, the Court reached a similar result, finding that generic drug companies cannot be held responsible when their labels are incorrect or inadequate. Resting on a peculiarity in FDA law that prevents generic drug companies from changing labels even if a hazard exists, the Court majority held that in this case, “Federal law does preempt a State law failure-to-warn claim.”
These cases are in contrast to the Court’s 2009 case Wyeth v. Levine, where the Court rejected preemption arguments and upheld a state tort suit involving an inadequate label for a brand-name drug. There, the Court recognized the important role that lawsuits play in ensuring the safety of prescription drugs, noting “[S]tate law offers an additional, and important, layer of consumer protection that complements FDA regulation.”
In sum, as the law now stands, whether or not an injured drug consumer has any legal recourse over the drug’s defective design or warning label depends entirely on whether they have been prescribed a brand-name or generic drug.
In PLIVA, the Court itself noted the peculiarity of this result, stating, “‘[I]t is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre.’ … As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.” Indeed, there have been calls for the FDA to revise its regulations to remedy this unfairness and to create parity between the responsibilities of brand name and generic drug companies to independently ensure safe product labels.
In response to a petition by Public Citizen, the FDA has now proposed such a rule change. Under this new proposed rule, a generic drug manufacturer would no longer be allowed to maintain a label it knows to be inaccurate or out-of-date. Whenever new information becomes available to a generic manufacturer that makes their product’s current label inaccurate, a generic company would be required to “take steps to change the content of its labeling.” Because of the public health issues at stake, the agency would make this new information publicly available on a web page where the FDA will promptly post information regarding the labeling changes.
There are good reasons why 80 percent of all drug prescriptions are filled by generic drugs today. However, no consumer saves money if a generic drug label is unsafe and she is medically harmed as a result—and then has no recourse in the courts. Changing the regulations in the manner proposed by the FDA is exactly the direction in which the Supreme Court pointed the agency.
The FDA’s comment period has been extended to March 13, 2014.

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