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PDUFA Reauthorization: How Does This Affect REMS?

By Edward Li, PharmD, BCOP, Drugs and Biologics Editor

Signed into law by President Bush on September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) contained a reauthorization of the Prescription Drug User Fee Act (PDUFA) until 2012. Historically, PDUFA is “the cornerstone of modern FDA drug review” by providing funds to the FDA to allow the timely review and approval of new drug applications. Additionally, FDAAA also provided to the FDA “enhanced authorities regarding postmarket safety of drugs,” also known as Risk Evaluation and Mitigation Strategies (REMS). These regulations were initiated to improve patient safety, but clinicians are struggling to meet the new regulatory requirements in their day-to-day practice. NCCN has previously written on this issue to illuminate provider concerns and provide recommendations for stakeholders, which are outlined in NCCN’s Oncology REMS White Paper.

Interestingly, one opportunity to address some of the issues with REMS could be through the reauthorization of PDUFA. As the date draws closer to reauthorize the next PDUFA program for 2013-2017, FDAAA requires the FDA to hold public meetings with stakeholders and industry to gather recommendations. Since July 2010, the FDA has held these meetings at least once per month, and REMS has been among the topics discussed at these meetings.

Of note, the FDA proposed better ways to standardize and integrate complex REMS into the health care system. During the September 29th meeting with stakeholder groups, the FDA stated that REMS involving restricted distribution systems (of which there are currently over 30) could be standardized such that providers are better able to incorporate requirements into the current health care system2. These requirements include mandatory provider education, patient monitoring, or enrolling patients into a registry. Additionally, over the past months, FDA officials hinted that the issue of medication guides could perhaps be addressed by removing them as a “REMS.”

It is clear that certain REMS programs have the potential to drastically impact oncology practice. For example, in February 2010, a REMS was issued for erythropoiesis stimulating agents (ESAs). This program requires oncology providers to register in a program (“ESA APPRISE”) and to complete a training module. Additionally, providers must discuss with the patient the risks and benefits of ESAs before beginning treatment and document the discussion. In an NCCN Trends™ survey conducted in March 2010, 40 percent of clinicians responded that they were registered in the program, and an additional 43 percent reported that they were planning on registering in the program soon. The deadline to enroll in the ESA APPRISE program is February 16, 2011, after which access to ESAs will be suspended for those who have not registered. As most clinicians have accepted these provisions regarding ESAs, any future standardization from the FDA may be a welcome improvement.

Visit the NCCN Resource Tool: Risk Evaluation & Mitigation Strategies (REMS) online at NCCN.org for additional information.

Sources:

  1. White Paper Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications.  http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm1
    19253.htm    .  Accessed November 8, 2010.

  2. Stakeholder Meeting on PDUFA V Reauthorization.  http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUser
    Fee/UCM229610.pdf    .  Accessed November 8, 2010. 

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