The Food Marketing Institute (FMI) appreciates the opportunity to comment on the Food and Drug Administration’s request for input on the availability of behind-the-counter (BTC) drugs. We applaud the FDA’s desire to study the public health implications of certain drugs being available without a prescription after intervention by a pharmacist. There are several issues surrounding the possible creation of a BTC class of drugs that are of particular concern to FMI, specifically how products will be evaluated for inclusion in the BTC class, what protections pharmacists will receive from claims of liability, how pharmacists will be reimbursed for their time, services and expertise, and the logistical issues that will arise with the new class. Given the complexity of this issue and the wide array of stakeholders affected, we thank the FDA for extending the comment period to ensure all stakeholders had an opportunity to be heard.

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