For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act of 2007 which requires REMS (Risk Evaluation and Mitigation Strategy) from drug and biologics manufacturers for products to ensure that any serious risks are outweighed by its benefits. REMS requirements can impose special duties on manufacturers, wholesalers, pharmacists, physicians, and/or patients. Failure to comply with a REMS potentially has significant legal consequences and patient safety implications.
Years ago we saw CME under attack by critics charging the education representing a way around FDA’s control of medical promotion. REMS changed this trend as the agency turned back to CME as the keystone to controlling a tough drug overuse/abuse situation. Specifically, FDA’s REMS approach for long-acting opioid pain products relies on physician education with materials pre-approved by FDA as the key post-marketing control tool.
Now, many years later, FDA recently launched REMS@FDA, a REMS database website. The user-friendly website contains a table of all currently approved individual and shared REMS, as well as a link to historical REMS. The table provides an at-a-glance overview of elements included in each REMS and links to detailed pages for the REMS. All REMS materials are downloadable in PDF format.
FDA has developed a number of REMS-related priority projects and in an October 2015 Federal Register announcement, the agency introduced a pilot project for the submission of final approved REMS and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. The goal is to make it easier for these documents to be integrated into pharmacy and hospital IT systems.
FDA says that stakeholders have “expressed concern that information about REMS materials, tools, and requirements are not communicated … in a clear and consistent manner,” and that “REMS materials and requirements may be difficult to locate,” and “difficulty integrating REMS materials and procedures into their existing health information systems and healthcare delivery processes.” FDA says it is looking for no more than nine volunteers to take part in the pilot and asks interested parties to apply by December 7, 2015.
Also recently, twenty health care provider and patient advocacy organizations forces announced an effort to counter what they view as recent efforts to weaken REMS linked to certain FDA-approved drugs. The move comes as generic drug advocates raise concerns that brand-drug makers are using REMS restrictions to delay generic competition. The group, Patients Alliance for Drug Safety Protections, says patients, policy makers and other key stakeholders have an extensive knowledge gap about how REMS work. The goal of the alliance and the website is to educate the public on FDA’s use of REMS to approve high-risk medications that would otherwise not be on the market and to keep them from being diverted to the black market.
Among the priority issues for the Alliance will be to preserve the integrity of safety programs like REMS with Elements to Assure Safe Use (ETASU). Drugs that are covered by REMS with ETASU face the greatest set of restrictions, including the use of registries, education programs for providers, pharmacies and patients, monitoring, and restrictions on distribution. Although these programs can add time and administrative requirements for health professionals and can be expensive for manufacturers to develop and operate, these extensive safety measures are required by the FDA under federal law to ensure that a drug’s benefits will outweigh its risks. ETASU components are rare, as only 36 drugs as to date have these programs.