M e d i c i n e A v e 2 inquiries to a company regarding an unapproved use may be responded to by a member of the medical or scientific staff, as long as there is no intent to promote or commercialize the product for the use in question, while company sales representatives are forbidden to initiate such conversations. Anticipating FDA Decisions and Actions FDA regulators operate not only with a large volume of law and regulations, but also with enormous discretionary authority. In rendering its decisions, FDA staff evaluate a company's activities based on a variety of factors including its history of Untitled or Warning Letters, its attitude when dealing with FDA, the nature of the company's responses, the history of actions against the company, and continued violations following receipt of letters calling for the cessation of activities that FDA wishes to curtail. The degree of seriousness of any given violation or complaint filed by a competitor or medical professional with FDA also plays a role in its decision-making. Conclusion The foregoing discussion provides a brief insight into current FDA regulatory requirements and some informed speculation about its current thinking concerning prescription drug advertising and promotion. Today's environment is not, however, a static one. In addition to FDA, other federal regulators are aggressively enforcing the Fraud and Abuse laws and using promotional practices, particularly those that promote off-label usage, as the centerpiece of their investigations and prosecutions. Advertisers also must be aware of and concerned about the evolution of requirements or policies of professional associations (eg, AMA, AAFF) and ACP) and trade associations (eg, PhRMA Guidelines for Interactions 66
RkJQdWJsaXNoZXIy NDMwNDAx