A proposed FDA rule responds to the Supreme Court’s disturbing decision in Pliva v. Mensing

By Erika K. Duthely, AFJ Dorot Fellow

Imagine this: your doctor prescribes you a drug. You head to your local pharmacy to have your prescription filled and the pharmacist offers you the generic version at a much lower price. He assures you that the drug is identical, except in name. But thanks to a federal regulation and a U.S. Supreme Court ruling, in exchange for the lower price, you may be giving away your right to sue if the label didn’t warn you about potential hazards and something went terribly wrong.

Simply because the drug is a generic, the manufacturer could be shielded from liability for an inadequate warning on the label.

Here’s the problem.  If the manufacturer of a brand name drug discovers new side effects after it’s on the market, the manufacturer has the right, indeed the obligation, to change the label.  But generic drug manufacturers can’t change their labels until the brand name manufacturer acts.  And once a drug is manufactured generically, the brand name manufacturer often leaves the market – and so is not looking for potential new side effects.

The tragic consequences are illustrated in this portion of AFJ’s brief documentary, Unequal Justice:

We are deeply saddened to report that early in 2013, a few months after her ninth surgery, Camille Baruch, who is featured in this video, died. The cause of death is not yet known, but her mother notes that Camille’s immune system was compromised by the drugs she had to take as a result of the illnesses described in the video. Ms. Baruch was 19.

In order to address this problem, the Food and Drug Administration recently released a proposed rule that would allow manufacturers of generic drugs to update label information more quickly once new health and safety information becomes available.  Alliance for Justice joined with the Center for Justice and Democracy (CJD) and a number of other groups in submitting comments in support of the FDA’s proposed rule.

As the comments we submitted state, as things stand now:

a generic drug manufacturer [can] maintain a label even if it knows that label to be inaccurate and out-of-date. In addition to raising serious safety concerns, the current regulations have had severe legal consequences for patients harmed as a result of unsafe generic drug labels.

Those severe legal consequences stem from the Supreme Court’s 2011 decision in PLIVA, Inc. v. Mensing (the case discussed in our video) where, as our comments state,

[T]he U.S. Supreme Court immunized the generic drug industry for marketing drugs with labels they know to be inaccurate and out-of-date because current regulations prevent generic companies from independently changing drug labels.

As Alliance for Justice has previously noted, the dissenters in PLIVA “identified three ‘absurd consequences’ that will result from the Court’s decision.”

First, generic drug consumers will have no access to compensation when they are injured by inadequate warnings.  This creates an “arbitrary distinction” between brand-name and generic-drug consumers that Congress did not intend to create.  As a result of this decision and the 2009 Wyeth decision, the majority concedes that a consumer’s ability to seek compensation for injuries depends on whether a pharmacist fills a prescription with the brand-name or generic version of a drug.  Many states allow pharmacists to unilaterally make such substitutions.  Second, generic-drug manufacturers will no longer have the same state-law incentives to monitor and disclose safety risks that brand-name manufacturers have.  As the dissent observed, “brand-name manufacturers often leave the market once generic versions are available, meaning that there will be no manufacturers subject to failure-to-warn liability.”  Third, the decision undercuts the goals of the Hatch-Waxman Amendments to increase the consumption of less expensive generic drugs.  Doctors will be more hesitant to prescribe generic drugs and patients will be less likely to take them because generic-drug manufacturers will now face weaker safety incentives.

According to the FDA, PLIVA “alters the incentives for generic drug manufacturers to comply with current requirements to conduct robust postmarketing surveillance, evaluation, and reporting, and to ensure that the labeling for their drugs is accurate and up-to-date.”

As our comments state, this proposed rule is necessary because it “would ‘create parity’ between brand name and generic drug companies to independently ensure safe product labels. American patients and prescribing physicians deserve no less.”

We urge the  the FDA to implement this rule—and restore justice for generic drug consumers—without delay.

Find out more about  PLIVA v. Mensing here.