ETHICS: Ethical Considerations Relevant to Communications with FDA
4:15 Registration to Workshop B This one-hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios involving situations in which FDA requires full disclosure of adverse information and authority. For example:
- In the context of citizen petitions FDA requires certification that the petition includes all information and views on which the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. 21 CFR 10.30. The discussion will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7 and 1.8 of the Rules of Professional Responsibility.
- In the context of an Advisory Committee meeting at which counsel is present, Committee members ask whether all data regarding adverse events have been reported to FDA. The discussion will cover the implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.
- Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending NDA. The discussion will cover the implications of Rule 1.11