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M-03: Assessment of the United States REMS Program Requirements for NDAs and BLAs

Poster Presenter

      Nina A. Johnson

      • PharmD Candidate 2019
      • Western New England College of Pharmacy
        United States


The first full year of FDAAA implementation, 2008 through to 2016, were reviewed to assess if FDA requirements for safety risks identified differenced in REMS for CDER’s New Drug Applications (NDAs) compared to Biologics License Applications (BLAs).



The following FDA sources were reviewed: REMS @ FDA, Approved Risk Evaluation and Mitigation Strategies (REMS), Released REMS, Drugs @ FDA, CDER New Drug Approvals by Calendar Year, CBER new drug approvals by calendar year, and Drugs @ FDA. The data was reviewed for years 2008-2016.


During the years of 2008-2016, CDER approved 930 new drugs; 93.1% being NDA and 6.9% being BLA approvals. Of the 930 CDER new drug approvals, 127 were required to have a REMS on product approval; 12.1% of NDAs and 34% of BLAs required REMS, respectively. The highest requirements for both NDAs and BLAs were seen during the first three years of the REMS implementation. Additionally, there was a higher percent likelihood for BLAs to have a REMS requirement at product approval. Since implementation, 170 of the approved REMS have been released by the FDA; 8 ANDAs, 136 NDAs and 26 BLAs. In comparison of REMS lifecycles, the NDA and BLAs both had similar release rates. Unreleased approved REMS included 47 NDAs and 12 BLAs. The risks identified in each of the unreleased REMS programs were assessed to determine the safety practices of the FDA’s REMS programs. Adaptation of the Medication Dictionary or Regulatory Activities, (MedDRA) System Organ Class, terminology was utilized to categorize the risks in each REMS program. The 47 unreleased approved NDA REMS programs included 57 identified risks. The risk identified most frequently was injury, poisoning, and procedural complications with 16 risks identified [24.6%]; constituting mostly accidental/secondary exposure and misuse/abuse. The second highest risk identified in the NDA REMS was pregnancy, puerperium, and perinatal conditions [13.8%]. Within the BLA’s REMS, there were 24 identified risks in the 12 unreleased REMS programs. The risk most frequently identified was neoplasms benign, malignant, and unspecified with a total of 5 identified risks [41.7%]. In comparison, risks of neoplasms was identified only 3 times [4.6%] in NDA REMS programs. Immune mediated conditions was the second most identified risk observed in BLAs, with 4 identified risks [33.3%] and identified in 1 of the NDA programs [1.5%].


Since implementation of the REMS program, the FDA’s CDER has required NDA and BLA drug products to include REMS programs. During the investigation period, NDAs had greater new drug approvals in comparison to BLAs. However, 35% of BLA new drug approvals required a REMS on product approval compared to 12% of the NDAs. Collectively, there has been 221 REMS programs approved during 2008-2016 for NDA and BLA drug products. Following REMS approval, there was no significant difference observed in the release rate between both NDA and BLA programs, demonstrating no additional scrutiny on BLAs despite the higher likelihood of requirements observed at product approval. The type of identified risks differed in the NDA and BLA REMS programs. BLAs exhibited risks more frequently of neoplasms, immune mediated disorders, and infection, while NDAs included risks of injury/poisoning and pregnancy/perinatal conditions. With the increase of CDER’s BLA new drug approvals coupled with an overall increase in the research and development of biologic therapies, BLA drug manufacturers approaching product approval can anticipate to require a REMS program. Based on the study observation, the risks identified for BLAs will be associated with immune system modifications including infection, neoplasms/carcinoma, and immune mediated disorders. Although close in frequency of identified risks of neoplasms/carcinoma and infections between NDAs and BLAs, the requirement for BLA REMS programs is seen far greater, with less approved products.