Participated in weekly review sessions with Marketing, Medical and Regulatory representatives to ensure that promotional materials for IV antibiotic drug comply with FDA requirements and to minimize legal risks of Lanham Act (competitor lawsuits), product liability and government prosecution for off-label promotion.
Guided prescription drug company on analysis of off-label medical journal reprints and minimized legal risks associated with sales representative distribution.
Counseled prescription drug company selling branded and generic drugs on FDAAA requirements for clinical trial disclosure laws and best practices for correcting past errors in NDA/ANDA submissions.
Conducted on-site training at biopharmaceutical company on lawful communications of clinical trial results and pre-approval promotion as the company prepared to submit a BLA for approval of its prescription biologic.
Conducted review of prescription drug company policies and procedures and draft revisions, as well as supplemental documents, to ensure compliance with PhRMA code, as well as state specific codes of conduct.
Counseled company with orphan drugs and medical foods on compliance with state and federal aggregate spend (""Sunshine Act"") disclosure laws andproduct sample disclosure laws, as well as laws imposing spend limits or bans on marketing expenditures.
Provided legal counsel on social media-related incentive programs for patients to earn charitable contribution "rewards" and evaluate potential anti-kickback and false claims act implications.