OTC Crunch Time in California - Pharmaceutical Executive

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OTC Crunch Time in California

Pharmaceutical Executive


Existing FDA requirements

FDA regulation of OTC drugs entails consideration of human health effects and environmental impacts. There are two regulatory pathways that ensure the safety of the chemicals used in an OTC drug. OTC drugs are either approved through a new drug application (NDA) or must conform to a drug monograph issued by FDA. Through the NDA process, FDA approves a drug if, and only if, it is shown to be safe and effective. FDA permits an Rx-to-OTC switch if there is a long history of safe use, a prescription is no longer necessary to ensure safe use, and it is in the public interest to increase access at a lower cost. Similarly, drug monographs outline detailed conditions to which the OTC drug product must conform in order to be legally marketed. The use of active ingredients is specified in the monograph by dosage strength and dosage form. The active ingredient in a drug monograph has been extensively assessed by FDA for human health effects, for purposes of both safety and efficacy.

Through this detailed assessment, FDA determines what level of chemical is not hazardous and acceptable for use—i.e., conditions under which an OTC ingredient is generally recognized as safe and effective. The monographs contain specific requirements regarding permissible active ingredients, dosage strength, directions for use, claims, warnings, and precautions. The entire OTC monograph development and assessment process is conducted by FDA through public, notice-and-comment rule making, based upon recommendations by expert advisory panels.

The California Safer Consumer Products regulations are largely duplicative of FDA's regulation of OTC drugs. Although the Safer Consumer Products regulations do permit DTSC to grant a regulatory exemption from a requirement if it is in conflict with a federal regulatory program, such that the responsible entity could not reasonably be expected to comply with both, there is no guarantee that DTSC would do so for OTC drug products. Moreover, the burden should not be on industry to resolve conflicts and overlap between regulatory regimes. To obviate the need for a DTSC regulatory exemption, the pharmaceutical industry needs to take an active role and demonstrate to the California legislature that its proposed regulation of OTC drugs is preempted by the federal Food, Drug and Cosmetic Act (FDCA) and FDA regulation of OTC drugs.

In our view, the FDCA, the FDA's NDA process and drug monograph requirements likely preempt the Safer Consumer Product regulations as they relate to OTC drug products. Section 751 of the FDCA expressly preempts states from imposing additional regulation on OTC drugs: "no state may establish...any requirement (1) that relates to the regulation of a [nonprescription] drug...and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter."

In this regard, the statute dictates that "a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug." Courts have held that federal laws preempt conflicting state laws when it is the "clear and manifest purpose of Congress to do so." An express preemption provision, such as Section 751, is direct evidence of congressional intent to preempt state law. The Safer Consumer Product regulations, as they relate to OTC drugs, are different from, and in addition to, the FDA regulations of OTC drugs. Therefore, they should be interpreted as being preempted by the FDCA.

The bottom line

In sum, California's Safer Consumer Products regulations could impose significant financial costs and other related regulatory burdens on OTC drug manufacturers, and may even bar the sale of OTC drug products in the California market. There is a strong argument that the DTSC requirements conflict with and are preempted by FDA laws and regulations. However, manufacturers cannot expect a quick and favorable judicial review of the preemption issue after implementation of these new regulations. By then, industry may also have to contend with product liability claims. It must take action on the legislative front—beginning now.

Maureen Gorsen is a partner at Alston & Bird LLP. She can be reached at
. Cathy L. Burgess is a partner at Alston & Bird LLP. She can be reached at
. Elise Paeffgen is an Associate at Alston & Bird LLP. She can be reached at
.


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