Xecor makes several drugs, including Anxless, approved by the FDA for the treatment of anxiety. Recent studies
Question:
Xecor makes several drugs, including Anxless, approved by the FDA for the treatment of anxiety. Recent studies sponsored by Xecor indicate that Anxless may be a promising treatment for hypertension. Dr. Mabel is a pharmacy professor whom Xecor approached to see if she would be willing to present hypertension CE programs. The company told Dr. Mabel it would pay her $2,000 per one-hour program and would give her the slides to use. Dr. Mabel agreed, and Xecor sponsored a CE program at a local restaurant and personally invited the pharmacists. Most of the program was about the recent studies demonstrating how effective Anxless is for hypertension. The company also distributed articles to attendees discussing these studies. The FDA monitored the program and issued warning letters to Xecor and to Dr. Mabel. Explain the legal and social policy arguments as to why this program might violate FDA guidelines and why it might not. What legal violation might Xecor and Dr. Mabel have committed?
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The situation involving Xecor Dr Mabel and the promotion of Anxless for hypertension provides a complex case to analyze under both FDA guidelines and broader legal and social policy considerations Her...View the full answer
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