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funded animal research – primarily the NIH and the USDA – the recommendations aim to address the numerous conflicting, outdated, or ineffective regulations that do not improve animal welfare.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.
Manufacturing related supply constraints for NULOJIX® (belatacept)
In October 2016, Bristol-Myers Squibb (BMS) initiated communications with the U.S. Food and Drug Administration, European Medicines Agency, and other health authorities in applicable European and South American countries to notify them that a delay in transition to a more efficient manufacturing process, which is needed to meet growing demand for Nulojix, had created a potential supply constraint in 2017. At that time, steps were taken to mitigate the potential supply constraint. Based on growth in new prescriptions, BMS projects that the commercial supply of Nulojix in 2017 will not be sufficient to enable new patients to start treatment with Nulojix.
Starting March 15, 2017, no new patients will be able to start Nulojix. BMS is committed to maintaining supply for patients currently being treated with Nulojix. In order to preserve the ability of existing patients to receive Nulojix, you must register your existing patients in the Nulojix Distribution Program and receive a unique patient identification number, which will be required to order Nulojix. Distributors will request this information. The unique patient identification number can be obtained by completing the registration form and receiving notification of enrollment.
BMS anticipates that, subject to regulatory approval, the transition to the new manufacturing process will be completed at the end of 2017, which will enable supply to new patients again starting in 2018.
Information detailing the Nulojix Distribution Program will be communicated by your local BMS contacts. If you have any questions regarding this program, please call 1-855-511-6180 from 8 AM to 8 PM ET, Monday through Friday (except holidays).
October 13, 2016
CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery
The Centers for Disease Control and Prevention (CDC), in collaboration with National Jewish Health, has identified additional laboratory information in its ongoing investigation into heater-cooler units used during open-chest cardiac surgery. The new laboratory findings demonstrate that the Stöckert 3T heater-cooler devices manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) linked to outbreaks in several states, were likely contaminated during the manufacturing process. These units represent about 60 percent of the heater-cooler devices currently in use in the United States, and may be putting patients at risk for severe infection from slow-growing bacteria known as Mycobacterium chimaera.
CDC is advising hospitals to alert clinicians and patients of this risk and advise patients to seek immediate medical care if they have had open-chest cardiac surgery and are experiencing symptoms such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever.
Read more on the CDC website.
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/.