FDA’s Rules Prohibit Tissue Collection from LGBTQ+ and African Donors
(Thursday, November 10, 2022)
An antiquated FDA policy prohibits collection of tissues, cells, organs, and blood from gay donors and sub-Saharan African immigrants. These prohibitions apply even if vigorous testing shows these donors to be non-infectious and healthy. These prohibitions are enforced by the FDA through improper means via its Guidance Documents and not through the appropriate regulatory process. Organ, tissue, cells, and blood donations are critical for several lifesaving and life-altering medical applications. Human cells and tissues have been used in medical practice to treat patients for hundreds of years and, recognizing their necessity in medical practice, the regulations allow donated cells and tissues to be provided to patients without any formal approval from the FDA. Therapeutic products derived from tissues, cells, and blood from human donors, collectively called the “Human Cells, Tissues, Cellular and Tissue-based products” or HCT/Ps, are regulated under 21 CFR 1271 (the 1271 rules). The 1271 rules do not describe the prohibitions listed above but require common sense approaches to prevent collection of tissue donations from infected donors. The prohibitions were introduced by FDA via its Guidance Document for donor screening finalized in 2007 based on data reported in publications from 20 years earlier. At the height of the AIDS epidemic in the early 1990s, there were several concerns about preventing infections such as HIV and hepatitis viruses, which at that time were prevalent in the gay communities in the US and Europe, and several African countries. Hence, the guidance also prohibits donation by immigrants from several sub-Saharan African countries and their families, any person who lived for a cumulative 5 years or more in European countries in the last 40 years, and anyone who lived with or had any relationship with these prohibited donors. Those concerns are no longer valid 30+ years after the AIDS epidemic when we have several highly accurate and reliable tests which provide an almost 100% certainty of finding infections. However, this policy is still enforced by the FDA’s auditors, likely illegally, citing the Guidance Documents. The Guidance Documents, by definition, are non-binding “opinions and suggestions” but enforcement must be for compliance with the regulations, making enforcement outside of the 1271 rules to be outrightly questionable. Manufacturers have no option but to apply such restrictions on their donors or face regulatory actions. The screening questions that the collection agents are forced to ask donors are highly improper and inappropriate creating opportunities for false responses and discrimination against the LGBTQ+ community. And in the process, this has created a shortage of healthy donors for HCT/Ps creating a supply and demand imbalance leading to higher price pressures for patients. The biggest impact is on African donors from whom there is an acute shortage of available HCT/Ps. Professional, organizations such as the American Association of Tissue Banks (AATB) have parroted the FDA’s guidance as well, instead of challenging the relevance of these restrictions, exacerbating the issue for their members. There have been a few attempts to urge FDA to update this policy, most notable a Congressional letter to FDA exactly one year ago, but so far there are no indications that FDA is listening. But it is time for FDA to amend these discriminatory and non-scientific anti-LGBTQ+ and anti-African practices because clearly that was not the intent of the Agency or the US Congress.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC