On The Docket
David B. Brushwood, BSPharm, JD
The federal Food, Drug, and Cosmetic Act (FDCA) classifies drugs as either Rx only or OTC. The standard for Rx only classification applies to any drug that is “not safe for use except under the supervision” of a state-licensed prescriber. The OTC classification applies to any drug that is capable of being labeled for safe use without prescriber supervision. The difference between these two foundational classifications is dependent on the labeling. The plaintiff in a recent lawsuit alleged that the labeling of a pharmacy’s “house brand” of OTC dextromethorphan (DXM) is false and misleading.
Background
According to the court, the “plaintiff alleges she was misled into purchasing [the pharmacy’s] branded ‘Non-Drowsy’ cough and flu OTC medicine at a premium price under the false representation that it did not cause drowsiness when it did.” The plaintiff alleged that the pharmacy had violated state law. The plaintiff alleged that the pharmacy misled patients into believing that the medication does not cause drowsiness by including the word “non-drowsy” on the product’s label. The plaintiff alleged that in fact DXM is “scientifically proven to cause drowsiness.”
The pharmacy moved for dismissal of the case, arguing that the plaintiff’s state claim is preempted by the federal FDCA which regulates the marketing and labeling of OTC drugs.
Rationale
The court first noted that a state law claim is preempted if it seeks to impose requirements that differ from, or add to, federal requirements. For example, a lawsuit that seeks to impose additional warnings for drug product labeling under state law is preempted.
The court reviewed the language of FDA’s antitussive OTC monograph and concluded that although the monograph requires drowsiness warnings for products containing diphenhydramine, there is no such requirement for OTC products containing DXM.
The court then explained that the plaintiff in this case did not claim that the pharmacy should remove a statement from its packaging that the FDCA requires or that the pharmacy should include a statement that the FDCA does not require, such as “may cause drowsiness.” Either claim would be preempted by federal law. Instead, the plaintiff was seeking to hold the pharmacy liable for adding the language “non-drowsy” to OTC antitussives containing DXM. She alleged that the pharmacy added this language to its packaging voluntarily and that describing DXM as “non-drowsy” is inaccurate and misleading.
The court noted that under the FDCA misbranding standards, there is a “general prohibition against false or misleading labeling.”
The court held that “the plaintiff is not seeking to impose a requirement that is different from the federal requirements, but rather, her claim is parallel to federal law because she is seeking to hold [the pharmacy] accountable for labeling that she alleges is false, deceptive, and misleading.”
The court concluded that the plaintiff’s state law claim was not preempted by federal law. The pharmacy’s motion to dismiss the lawsuit was denied.
Takeaways
While the ultimate outcome of this lawsuit is yet to be determined, the limits of federal preemption are clear under this ruling. Pharmacies that add language to the labeling of their OTC products, beyond statements that are mandated by FDA’s OTC monograph, with the intent of facilitating patient self-medication, do so at the risk of being sued for misbranding.
This case confirms what pharmacists already know: The printed language on OTC product labeling is insufficient to assure safe medication use. Labeling has limits. Pharmacists have traditionally played a significant role in verbal consultation with patients regarding the safe and effective use of OTC medications. Unfortunately, the overwhelming challenges of contemporary community pharmacy can make it difficult for pharmacists to fulfill that role.
Pharmacists who are interested in meeting a critical patient need for accurate information about self-care can find guidance on developing a self-care niche in pharmacy practice by studying APhA’s publication Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. ■