1. PREEMPT safety concerns by assuring healthcare professional and patient groups, the FDA and other key governmental officials and the general public that the company will review all mesial evidence and cooperate with the FDA.
2. INITIATE an independent review by experts of the medical evidence and request their recommendations for improvements in labeling, professional and patient education initiatives and other steps to optimize safety.
3. BRIEF AND ENLIST the assistance from the key third party medical; professional and patient groups, governmental and other interested parties in supporting the independent medical review and company actions.
4. BROADLY COMMUNICATE the independent review and company actions directly and through the media to physicians, healthcare providers, patients, the general public and the company's employees and shareholders.
5. DEVELOP and initiate voluntary educational efforts to enhance product safety and efficacy as a precautionary measure irrespective of the merits of the product attacks or ultimate outcomes of the medical review.
6. FOLLOW THROUGH on all promised actions and keep FDA, key audiences and the general public frequently updated.
Source: Dack Dalyrymple, Baily and Dalyrymple, Washington, D.C. (202/833-1043).