January 03, 2020
The Center for Biologics Evaluation and Research (CBER) issued an annual report last week to highlight the agency’s ongoing efforts to improve and protect public health. The report summarizes the agency’s product approvals, efforts to advance product development, actions to improve public safety, mission-related research and guidance documents from the 2019 fiscal year.
The 2019 report features several notable approvals, including two assays to detect genetic material from Babesia species of protozoan parasites in whole blood specimens, an additional treatment for hemophilia A and a vaccine for dengue virus. It also explores CBER’s efforts to advance biologic and human cells, tissues, and cellular and tissue-based product (HCT/P) development through the establishment of the CBER Advanced Technologies Team (CATT) and the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), respectively.
In addition, CBER shared its progress following the November 2018 memorandum of understanding with the U.S. Department of Defense (DOD) to advance the development of products prioritized by DOD to ensure the highest level of attention from the agency. This includes an August 2019 variance to the Department of the Army that allows cold storage of platelets for up to 14 days to treat active bleeding when conventional platelets are unavailable or their use not practical.
The report outlines CBER’s actions to ensure the safety and effectiveness of new therapies, as well. In 2019, CBER issued 60 letters to separate manufacturers and health care providers across the country that appeared to be offering unapproved stem cell products to treat a variety of diseases or conditions.
The agency also advised caution to consumers concerning infusions of plasma from young donors and claims that the plasma will treat a variety of conditions including normal aging and memory loss. The Food and Drug Administration initiated efforts to maintain the safety of the blood supply, informing blood establishments of recent reports of platelet contamination with Acinetobacter species bacteria, as well.
The report also includes materials from the 2019 meetings of the Blood Products Advisory Committee and data from the Transfusion-Transmitted Infections Monitoring System (TTIMS).