Drug developers, healthcare providers, insurers and others involved in the delivery of healthcare in the US are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategies programme, a new study shows.
The agency was given authority by the FDA Amendments Act of 2007 to require drug developers to create a REMS as part of a new product approval application, and sometimes for a previously-approved product, when the FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. However, three-quarters of organisations consulted for the study, conducted by the Tufts Center for the Study of Drug Development (CSDD), said they believe the REMS programme needs a “major overhaul.”
Moreover, 68% of the organisations also regard REMS as a poor substitute for other improvements which they believe are necessary right across the system in terms of drug education, communication, use monitoring, patient access and delivery of care, according to the findings of the study, which is the first systematic look at the initiative since the FDA introduced it in 2008 and is reported in the January/February Tufts CSDD Impact Report, published yesterday.
“Most respondents said it is virtually impossible to measure the benefits of a REMS - compared to its burdens on patient access and cost of health care delivery - for a newly-approved drug, and that even for an already-approved drug it would likely require two years or more to effectively conduct such an assessment,” said Christopher-Paul Milne, associate director at Tufts CSDD, who conducted the assessment.
86% of respondents told the researchers that, under current guidelines, risk and benefit information was not well balanced in REMS communications, while only 22% said they thought the programme has been an improvement over the existing risk management system.
Nevertheless, the programme is expected to impact a growing number of healthcare stakeholders as the number of products with REMS expands in coming years, Dr Milne forecasts.
• The FDA has approved a total of 163 REMS since 2008. The first, issued in April that year, were for GlaxoSmithKline/Pozen’s migraine drug Treximet (sumatriptan and naproxen sodium), Sanofi-aventis’ Aplenzin (bupropion hydrobromide) extended-release tablets for the treatment of Major Depressive Disorder (MDD) and GlaxoSmithKline’s Advair Diskus 250/50 mcg (fluticasone propionate) for patients with patients with asthma and chronic obstructive pulmonary disease (COPD). The most recent is for Sanofi-aventis’ ketolide antibiotic Ketek (telithromcyin), approved last month.