FDA To View Managed Care "Sophistication"

The US Food and Drug Administration has announced a series of open meetings, to be held October 18-20 to discuss issues raised by direct-to-consumer advertising of pharmaceuticals, and also to assess the "sophistication," or level of education, of the new managed care buyers in relation to information and promotion activities undertaken by the drug industry.

Announcing the open meetings in the Federal Register last month, the FDA said the rapid growth of managed care and new drug marketing promotion strategies have meant more attention being paid to product value as well as safety and efficacy. Moreover, the audience for this type of information has changed, and now includes more institutional decision-makers. Through the open meeting, the FDA will seek to discover who now is receiving and/or asking for drug information supplied by the industry, and whether these people are more "sophisticated," or better-educated, than the traditional audiences for this type of information.

The agency says a number of companies with which it has discussed the inclusion of pharmacoeconomic data in promotions to managed care companies have told it that there is no need for these promotions to adhere to traditional standards of substantiation because the recipients are highly-educated and "able to regulate the process by creating a demand for supporting studies that display scientific rigor."