Ad Standards Council Issues DOH Administrative Order No. 2014-0040 Revised Guidelines on the Need/Role of Medical Director in the Pharmaceutical Industry

Upon request by the FDA, the ASC will implement Administrative Order No. 2014-0040 specifically Provision VI A2.1e on Policies and Procedures on the Roles and Functions/Responsibilities of the Medical Director which reads: Approval of all package inserts, labels, brochures and other labeling and promotion materials.

The Administrative Order requires the Medical Director to approve and sign ALL package inserts, labels, brochures and other labelling and promotional materials.

Per FDA, it is clear with the pharmaceutical companies and their respective Medical Directors that promotional materials include ALL advertising and promotional materials, i.e., TV, Radio, Print, Out-of-Home, Social & Digital Media and other materials.

Hence, all advertising and promotional materials of pharmaceutical companies submitted to the ASC starting Tuesday, September 1, 2015 must have the signature of the company’s Medical Director.

Thank you.