In 2007 the FDA Amendments Act (FDAAA) of 2007 was signed into law and provided the FDA the authority to require Risk Evaluation and Mitigation Strategies (REMS). Since its enactment, the FDA has required both new and previously approved drugs to develop REMS consisting of one or more elements provided for in the provisions. The goal is to put in place risk-reducing processes to ensure that the benefits of a drug or biological product would outweigh associated risks.
REMS can also facilitate approval of high-risk drugs or allow drugs to stay on the market. REMS may contain the following components: patient package insert, medication guide, communications plan, elements to assure safe use (ETASU) and an assessment timetable.
The bill requires that the FDA use electronic medical records as the source of data to track all aspects of product safety and perhaps outcomes (efficacy). The records are not billing based but are the actual patient charts. For more information and a complete list of FDA approved REMS, CLICK HERE.
Below is detailed information about REMS programs specific to ASTS members and the patients they serve.
The FDA has determined that a Risk Evaluation and Management Strategy (REMS) is necessary to ensure that the benefits of NULOJIX (belatacept) outweigh the risks of post-transplant lymphoproliferative disorder (PTLD) and progressive multifocal leukoencephalopathy (PML), both of which can be fatal. The NULOJIX REMS is designed to inform healthcare providers about the increased risk of PTLD, predominantly involving the central nervous system (CNS), and PML with NULOJIX.
Bristol-Myers Squibb has established the ENLiST (Evaluating NULOJIX Long-Term Safety in Transplant) Registry to further evaluate the safety profile of NULOJIX. ENLiST is intended to enroll all adult kidney transplant patients who are treated with NULOJIX, regardless of when NULOJIX is initiated. The primary objective of ENLiST is to determine the incidence rate of PTLD, CNS PTLD, and PML in US adult EBV seropositive kidney transplant recipients treated with NULOJIX.
For more information, visit http://www.nulojix.com/hcp/rems.aspx
The FDA has mandated a REMS program to tell doctors, nurses, pharmacists and patients about the risks of taking mycophenolate during pregnancy. The FDA determined that a REMS is necessary to ensure that the benefits of mycophenolate outweigh the risks of first trimester pregnancy loss and congenital malformations associated with mycophenolate use during pregnancy. For more information about this REMS, visit https://www.mycophenolaterems.com and https://mycophenolatepregnancyregistry.com/.