Review of FDA Public Hearing Transcript on Behind-the-Counter Availability of Certain Drugs

Abstract

OBJECTIVES: To explore the viewpoints of physicians, pharmacists, and other healthcare professionals on the creation of a behind- the-counter class of drugs. METHODS: This was a descriptive study of testimony contained in public hearings that were held by the FDA regarding behind-the- counter availability of certain medications. A data collection form was created to classify the testimony into categories according to the list comprised of 14 general issues, 11 logistical issues, and 11 miscellaneous issues. Testifiers were divided into three groups: medical, pharmacy, and health care related. Testimonies were analyzed for issues addressed by each speaker and marked pro, con, or neutral next to the corresponding issue. Frequencies and percentages were derived from the count data and groups were compared using a Yate’s Chi-square test. RESULTS: The medical, pharmacy, and health care related groups had a significantly different number of responses (p<0.001). The responses of the medical testifiers were significantly more opposed to a BTC class than the pharmacy testifiers (p<0.001). The pharmacy testimony was also significantly more in favor of a BTC class compared to the health care related groups testimony (p=0.014). The medical testimony was not significantly different from the health care related testimony (p=0.064). CONCLUSIONS: Pharmacists supported and physicians opposed the creation of a BTC class of drugs. Other healthcare related professionals had mixed opinions as a group.