Resources for Transplant Professionals
FDA Issues Letter on Safe Use of Surgical Staplers and Staples
The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices. In addition, we are announcing new actions we intend to take to help ensure the safe use of these devices.
AAMC, FASEB, COGR, and NABR Announce New Report on Regulatory Burden
The 21st Century Cures Act instructs the National Institutes of Health (NIH) Director to work with the Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) to identify ways the government can reduce regulatory burden on researchers. A new set of recommendations
proposes changes to federal regulations, policies, and guidelines governing the use of animals in research. Directed to federal agencies involved in the oversight of federally funded animal research – primarily the NIH and the USDA – the recommendations aim to address the numerous conflicting, outdated, or ineffective regulations that do not improve animal welfare. The proposed changes would ensure that standards of care in animal research are maintained and would have the practical effect of promoting efficiency among researchers.
The report grew out of an April 2017 workshop convened by the Federation of American Societies for Experimental Biology, the Association of American Medical Colleges, the Council on Governmental Relations, and the National Association of Biomedical Research. The workshop participants sought to identify federal requirements that demand significant administrative effort but do not enhance animal welfare.
Update on REMS for NULOJIX (belatacept)
The REMS for NULOJIX (belatacept) was originally approved by the Food and Drug Administration (FDA) on June 15, 2011. On May 9, 2017, the FDA determined that a REMS is no longer required for NULOJIX and has eliminated the REMS requirement. As a consequence, the distribution of the Pre-Infusion Checklist within the NULOJIX carton will cease.
The FDA determined that a communication plan was no longer necessary to include as an element of the approved REMS because the communication plan had been completed and the most recent assessment demonstrated that the communication plan had met its goals. Therefore, because the communication plan was no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for NULOJIX. The Medication Guide will continue to be part of the approved NULOJIX labeling.
FDA Issues Meeting Materials on Patient Focused Drug Development and Guidance on Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention
The Patient Focused Drug Development meeting for Patients Who Have Received on Organ Transplant was held at FDA September 27, 2016 and recently the Meeting Report: Voice of the Patient from this meeting has been posted on the website (along with the other documents related to the meeting). Patient-focused drug development is a component of FDA’s performance commitments for the Prescription Drug User Fee Act (PDUFA). FDA is interested in obtaining patients’ perspectives on the impact of diseases and medical conditions on their daily lives.
FDA recently published a new draft guidance on Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. The Federal Register notice of availability for this guidance and procedures to submit comments is available here.
6th Edition of the Council of Europe Guide to the Quality and Safety of Organs for Transplantation Published
This Guide contains the most updated information and guidance for all professionals involved in identifying possible organ donors, co-ordinators managing the process of donation after death and of living donation, professionals responsible for the allocation and clinical use of human organs, quality managers and Health Authorities responsible for overseeing donation and transplantation programmes.
In this 6th Edition, all of the chapters have been revised thoroughly to update their contents with the most recent advances in the field. In addition, new and important chapters have been added, including specific guidance for the determination of death by neurologic criteria, donation after circulatory death and living donation, among others.
This Guide has been elaborated by a dedicated and committed group of well-recognised international experts who did a tremendous job in sharing their expertise, in reviewing the literature and in extracting knowledge from numerous international guidelines, collaborative projects and diverse publications and websites with the aim of ensuring accessibility to all this information. The entire project has been an exceptional combined effort, with extensive discussions dedicated towards the common goal of increasing the safety, efficacy and quality of human organs for transplantation. The final result is this Guide, which constitutes a common European standard, based on the long-standing expertise and knowledge of the EDQM, Council of Europe. You may find more information about this Guide at https://go.edqm.eu/OTg.
With the aim of ensuring broad dissemination and use of this guidance document, the electronic version of this Guide is available for free download at the EDQM’s dedicated website (https://www.edqm.eu/freepub) after a simple registration process. Paper copies will soon be available for purchase at the EDQM Store (http://store.edqm.eu).
Availability of DRAI Addenda to Assist with Screening for Risk of Zika Virus Infection
To assist with screening donors for risk of Zika virus (ZIKV) infection an addendum and relevant flowcharts are available for use with any of the three Uniform Donor Risk Assessment Interview (DRAI) forms, and they are adaptable for use with any DRAI form style. Documents can be accessed at these links on the AATB website:
Zika Virus (ZIKV) Infection Addenda and Flowcharts
Deceased Donor (ZIKV)
The tools for a “Deceased Donor” assist with developing policies and procedures to screen a deceased donor of organs, tissues or eyes for risk of infection with ZIKV, and use “as is” is encouraged. The following guidance information was referenced to develop the tools:
A separate addendum and set of flowcharts should be used when screening a living donor who is a delivery mother of birth tissue (e.g., placenta). Both sets of tools meet expectations described in the immediate guidance issued by FDA/CBER on March 1, and their recommendations should be implemented by March 29, 2016.
NOTE: As knowledge is gained regarding risk of ZIKV infection associated with donation of organs, tissues or eyes, be aware that updates to the addenda and/or the flowcharts can occur.
Contact Scott Brubaker if you have questions after carefully reviewing all documents and published guidance.
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/.