A large portion of the cost of a drug's development comes from clinical trials that gather information about how the product affects patients. Now many consumers are sophisticated. The FDA should maintain the current level of scrutiny for promotional claims targeted at unsophisticated consumers. At the same time, the FDA should refrain from reviewing promotional activities between manufacturers and sophisticated consumers. This way we can protect the integrity of claims and the information available to the public without jeopardizing the evolution of the health care system.
Studies show that the quality of cost-effectiveness analyses varies widely.
Surveys have shown that institutional purchasers, as well as members of formulary committees, are confused by and mistrustful of cost-effectiveness analyses. This is an unnecessarily strict standard of evidence for cost-effectiveness information. The likely result will be fewer cost-effectiveness analyses conducted and disseminated, stifling potentially valuable information. The health care marketplace can generate its own more efficient and effective mechanisms for evaluating pharmacoeconomic information. Managed care plans and pharmacy benefit managers have the knowledge and economic incentives to determine the validity of pharmacoeconomic claims The FDA's appropriate role might be to impose disclosure requirements for all pharmacoeconomic promotional material while stopping short of requiring claims to be backed by well-controlled trials.