Theratechnologies, a pharmaceutical company based in Canada, had licensed out an approved prescription drug product to a U.S. drug company. Subsequently, Theratechnologies and the U.S. company agreed to return the drug back to Theratechnologies. The client has one in-house lawyer, so it sought help from expert outside counsel to comply with U.S. FDA and healthcare laws, as well as to negotiate contracts with U.S. specialty pharmacies and other third-party vendors to market the drug in the U.S.
Regarding FDA compliance, AGG reviews promotional materials and serves on the company’s Promotional Review Committee, has conducted in-house training of executive management and the Board of Directors on regulatory compliance, and has responded to day-to-day questions about FDA requirements. The firm’s Healthcare Practice has assisted with HIPAA questions, fraud and abuse and healthcare compliance issues, and state regulatory matters. AGG’s Corporate Practice has helped negotiate specialty pharmacy agreements and other distribution contracts. All of the issues have been time-sensitive because the publicly-traded company needs to start selling the product immediately.
Because the company was not familiar with the intricacies of U.S. law, AGG took on the responsibility of handling pressing assignments in a timely and cost-effective manner. The general counsel has worked with several U.S. law firms on other matters and said the relationship with AGG is among the best he has experienced.