Identical bills introduced simultaneously in the House and Senate propose to offer grants to independent third-party entities for developing and distributing physician and patient informational materials related to "prescription drug, non-prescription drug, and non-drug interventions." ("Non-drug interventions" likely are to be viewed as including medical devices and biologics.) The "Independent Drug Education and Outreach Act" (S. 767 and H.R. 1859) purports to "provide physicians and other prescribers with an objective source of information ... based on independent, scientific research" and sets out a two-tiered approach for issuing the grants.
The first tier provides grant money for organizations to produce educational materials on the safety, efficacy and cost of therapy. To be eligible for the grants, an entity must be a nonprofit or governmental organization such as a medical school, an academic medical center, a school of pharmacy, a medical society, a pharmacist society or research institute. In determining grant recipients for the development of educational materials, the legislation proposes that the U.S. Department of Health and Human Services (HHS) will consider the entity's capacity to develop the materials, the health conditions to which the materials will relate and the quality of the materials based on the type of sources relied upon, the likelihood that the sources accurately reflect the comprehensive body of available evidence, and the adequacy of the methods used to analyze the studies.
The second tier authorizes the awarding of ten grants by HHS for staff training on disseminating the educational material to physicians. Staff must consist of nurses, pharmacists or other clinically-oriented professionals. Organizations eligible to receive the second-tier grants include state or county public entities, nonprofit private entities, academic institutions or a partnership between a public and nonprofit private entity. HHS would be required to consider the entity's capacity to train appropriate clinicians, its proposed service areas, incentives for physicians to participate in the program (e.g., continuing medical education), and the methods proposed to provide the first-tier educational materials through physician and consumer outreach programs.
Importantly, recipients of both first-tier and second-tier grants would be precluded from receiving financial support from any entity that manufactures products used to treat the subject medical condition beginning one year prior to the submission of the grant application and ending one year after the receipt of the grant.