Ethical Issues in Prescription Drug Access under Restricted Distribution Programs

In 2007, Congress granted the Food and Drug Administration (FDA) the power to mandate that manufacturers implement so-called risk evaluation and mitigation strategies (REMS) for approved drugs with serious side effects. One possible REMS component—elements to assure safe use (ETASU)—are typically reserved for drugs with the most serious safety concerns and can range from patient monitoring; person, place, and volume restrictions on dispensation; and physician and pharmacist training and certification. Between 2010 and 2014, over 10% of newly approved drugs have been issued ETASU REMS. Despite such frequent use, however, little is known about the effects of ETASU REMS, including whether the additional prescribing burdens they impose reduce patient access, enhance costs, or improve patients’ experiences with their illnesses. This project seeks to address these questions. First, investigators will construct a comprehensive database of ETASU REMS and identify trends in the prescribing of certain medications subject to these programs. They will then conduct a series of interviews/surveys with patients and physicians exposed to ETASU REMS, FDA regulators overseeing such programs, and manufacturer representatives to better understand the administration of ETASU REMS and their impact on patient care. Based on their findings, investigators will propose ethical norms for the effective and equitable use of ETASU REMS.