FDA’s Proposed Rule on Generic Drug Labeling Could Sow Confusion and Chaos (and Lawsuits)

The FDA wants to give generic drug makers the same labeling authority as their branded peers. Attorneys Erin Bosman, James Huston, and Julie Park of Morrison & Foerster explain:

[T]he U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule … in an effort to ‘create parity’ between brand-name and generic manufacturers for their labeling obligations. […] Under the proposed rule, holders of abbreviated new drug applications (ANDAs) would be permitted to update product labeling with new safety information even if the revised labeling differs from the reference listed drug (RLD).”

The FDA hopes that the new rule will “speed the dissemination of new safety information about generic drugs to health professionals and patients.”

But changing the rules for generic drug labels could create a number of unintended – and potentially harmful – consequences. From attorneys writing on JD Supra:

1.       More failure-to-warn litigation:

“The rule … will have the intended effect of eliminating the shield to liability … for failure to make safety label changes. The FDA advises that ‘[i]f this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.’ Reviving these claims inevitably will subject generic drugs previously ‘out of bounds’ to new labeling suits, begging the question of whether, as a practical matter, generic labeling would in the future be influenced in some measure by the looming threat of legal challenges.” (Jason Drori, Michael Hinckle, Katy Koski, and James Matthews at K&L Gates)

2.       More disagreements over safety data:

“Also problematic – for manufacturers, prescribers, and consumers alike – would be disagreements among multiple drug application holders, be they NDAs or ANDAs, over the interpretation of postmarketing safety data and whether and when they warrant a label change. As the FDA points out, ‘decisions about how to address a safety concern often are a matter of judgment, about which reasonable persons with relevant expertise may disagree, and this may be reflected in different approaches to proposed labeling changes based on newly acquired safety information.’” (Drori, Hinckle, Koski, and Matthews)

3.       More confusion over labeling changes:

“While the FDA has clearly made an effort to ‘create parity among application holders with respect to’ certain labeling changes, implementation of the rule in its current form could very quickly lead to confusion. Multiple companies would be permitted to submit different labeling changes based on different information, with the NDA holder (if one still exists) responsible for evaluating the competing labels and submitting yet another proposal to the FDA.” (Erin Bosman, James Huston, and Julie Park at Morrison & Foerster)

4.       More health risks for consumers:

“Needless to say, confusing or inconsistent labeling for therapeutically equivalent medicines could pose serious health risks for consumers and sow confusion among drug firms, pharmacy providers, and health care practitioners. Those risks would be exacerbated if, as the FDA predicts, ‘health care practitioners are unlikely to review product labeling for each of the generic drugs that may be substituted for the prescribed product when making treatment decisions with their patients based on the balance of potential benefits and risks of the drug product for that patient.’” (Drori, Hinckle, Koski, and Matthews)

5.       More liability for all:

“If multiple labels are in effect at a given time, both generic and brand-name manufacturers would face increased exposure for failure-to-warn claims and be required to defend not only their own [changes being affected (CBE-0)] submission but also explain why other submissions were not adopted or incorporated. The 30-day window in which [abbreviated new drug applications (ANDA)] holders must update their labels will also open the door to ‘failure-to-update’ claims. And brand-name manufacturers’ post-marketing surveillance burdens will increase as they will be required to evaluate CBE-0 submissions from all ANDA holders (which is not accounted for in the FDA’s burden estimates).” (Bosman, Huston, and Park)

The updates:

Related reading:

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