CPR Submits Comments on FDA's Proposed Generics Labeling Rule

by James Goodwin

March 10, 2014

If you’re harmed by an improperly labeled prescription drug you’ve taken, should your ability to hold the manufacturer accountable in court depend on whether that drug was “name brand” or “generic”? Strangely, it does matter, thanks to the 2011 U.S. Supreme Court decision in Pilva v. Mensing. There, the Court held that because of a quirk in the Food and Drug Administration’s (FDA) regulations, generic drug manufacturers were shielded against plaintiffs’ state tort law failure-to-warn claims that alleged that a generic drug’s labeling failed to provide adequate warning of particular health risks.  The Court reasoned that since the FDA’s regulations didn’t readily allow generic drug manufacturers to update their labels quickly to warn consumers against any newly discovered risks, it would be impossible for those same generic drug manufacturers to fulfill a separate state tort law duty to provide such warnings through adequate labeling.  The impossibility of complying with both legal duties simultaneously compelled the Court to find that the FDA’s regulations preempted the plaintiffs’ state tort law claims. 

In the wake of that decision, the FDA has proposed to amend its regulations to eliminate this disparity.  Specifically, the proposal seeks to extend to generic drug manufacturers the ability to use the “changes being effected” supplement process (often called “CBE changes”) to make changes to their product labels.  It’s a little complicated, but the basic gist is that CBE changes enable drug manufacturers to update product labels relatively quickly whenever they become aware of certain kinds of information regarding the potential risks of their drugs.  The goal of the CBE changes process is to empower drug manufacturers to provide consumers and their doctors with relevant risk information as quickly as possible, so that they can make the best-informed decisions possible about whether and how to take a particular drug.   The public comment period for the proposal ends this Thursday, and CPR Member Scholars Tom McGarity and Sid Shapiro and I have submitted comments that aim to highlight for the FDA an important, but easily overlooked benefit of this rulemaking—namely, the invaluable role that a vibrant state civil justice system can play in complementing and reinforcing the FDA’s regulatory programs so that they are better able to protect the public against unreasonably dangerous drugs.

According to our comments:

This rulemaking would enable generic drug manufacturers to make CBE changes to update their labels—just as name brand drug manufactures are able to do now—making it possible for these manufacturers to fulfill their state tort law duty to provide consumers with adequate warnings regarding newly emerged risks posed by their products.   The rulemaking would therefore eliminate any justification for federal preemption of state tort failure-to-warn claims brought against generic drug manufacturers.  Without federal preemption, the state civil justice systems could once again resume an active role in policing generic drug safety.

They further explain: 

The synergistic dynamic that exists between federal regulation and state civil justice systems is present the area of drug safety.  In particular, state civil justice systems currently provide name brand drug manufacturers an additional incentive to manufacture, label, and distribute their products in ways that avoid harming consumers, even beyond what is specifically required by applicable laws and regulations.

Indeed, the additional deterrent effect provided by state civil justice systems is especially important for agencies such as the FDA that at times have become characterized by regulatory dysfunction.  Regulatory dysfunction occurs when agencies fail to regulate hazards that can and should be regulated or when they fail to implement or enforce the regulations they have issued.  These failures can occur for a variety of reasons, including shortfalls in funding, outdated authorizing statutes, political interference, and a demoralized civil service.  Under these circumstances, the direct deterrent effect of federal regulatory standards is severely diminished, making the indirect deterrent effect provided by state civil justice systems all the more important.  To be sure, vibrant state civil justice systems will not completely reverse the problem of regulatory dysfunction at the FDA, but they can help to alleviate some of its negative consequences.

For their part, generic drug manufacturers would prefer to maintain a status quo that allows them to avoid both enhanced regulatory labeling requirements and their tort obligations.  Consequently, the generic drug industry is working hard to block the FDA’s proposal. 

Generic drugs are now playing such a dominant role in the U.S. healthcare system that it just doesn’t make sense to treat them differently from name brand drugs when it comes to safeguarding consumers.  The FDA estimates that about 80 percent of all prescription drugs used in this country are generics, and now many prescription drugs are no longer available in name-brand form.  The generic drug industry has matured enough that it now has the financial clout and legal sophistication to abide by the new labeling requirements and the related state tort law duty of providing consumers with adequate warning of potentially harmful risks.  Accordingly, the FDA’s proposal can help to deliver significant public health and safety benefits by enabling state civil justice systems to play an active role in safeguarding the public against unreasonably dangerous generic drugs.

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Also from James Goodwin

James Goodwin, J.D., M.P.P., is a Senior Policy Analyst with the Center for Progressive Reform. He joined CPR in May of 2008.

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