HOUSTON (Newswire.com) – The Golden Gift announced today that affordable plasma interventions can have significant health and economic benefits to prevent or manage age-related conditions that account for a majority of our nation’s $4.5 trillion in annual health care expenditures: https://www.youngplasmastudy.com.
Plasma was approved for medical use by the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and since the formation of the Junior Red Cross on November 1, 1942, approximately 20 percent of our nation’s supply has been collected from young donors (AABB Donor Hemovigilance). Young plasma is an organic, renewable resource with an established infrastructure that is safe and healthy for individuals to donate frequently and for elder individuals to receive, forming a perfect circle for better health. Yet, or because of those facts and its unpatentability, our own FDA continues to aggressively defy the FDCA’s authorization of medically licensed off-label use of an approved biologic by deliberately attempting to restrict the availability and legal use of young plasma.
Dian Ginsberg, MD FACOG ABAARM: “Since 2018 I have been the Golden Gift’s Principal Investigator using young Fresh Frozen Plasma (yFFP®) to treat neurodegeneration and age-related diseases. Although the FDA annually reports that the blood supply is safer than it has ever been and we have documented significant efficacies, the FDA has repeatedly harassed me personally in my medical practice, both in-writing on September 25, 2019 and again in-person this July, that resulted in my filing a formal complaint (CPT2401333) on August 1, 2024, as well as attempting to intimidate the medical community and public through misleading public warnings the FDA published on February 19, 2019, and again on December 10, 2024, that falsely claim young plasma is an unapproved biologic. This harassment is similar to the way they interfered with physicians trying to use their knowledge and approved medications to treat COVID-19.” (“Convalescent plasma use in the USA was inversely correlated with COVID-19 mortality.” Johns Hopkins, Mayo Clinic et al June 4, 2021).
Spectrum Plasma, a fully accredited and FDA-AABB-CLIA audited outstanding blood bank that exclusively collects sex-identified plasma from 18-25-year-old volunteer donors, has had its Biologics License Application BL 125704/0 to ship outside of Texas unjustifiably withheld for more than five years by the FDA’s defiance of the July 10, 1973, U.S. National Blood Policy “to provide an adequate supply of blood, to ensure a higher quality of blood, and to facilitate maximum accessibility to services by sharing blood supplies nationwide.”
The FDA also directly contradicted its own public announcement on December 29, 2023, that “research has shown that biological differences between men and women may contribute to variations in the safety and efficacy of medical products” by demanding in writing on March 28, 2024, that Spectrum Plasma remove age and sex-identification from its unit labels that are allowed according to 21 CFR 606.121.