"While this administration may navigate the prior administrative law issues, several questions must first be addressed, including [1] Definition of 'developed' countries ... [2] Impact on generics and biosimilars ... [3] Framework for direct-to-consumer sales ... [4] Role of pharmacy benefit managers and insurance reimbursement ... Strategic considerations for drug manufacturers include ... [1] Participation in the notice and comment process ... [2] Internal review of drug prices ... [3] Preparing for antitrust scrutiny ... [4] Direct-to-consumer sales ... [5] Negotiations with foreign countries."  MORE >>