Blood Donation, Deferral, and Discrimination: FDA Donor Deferral Policy for Men Who Have Sex With Men

As part of its responsibilities to protect the safety of the American public, the United States Food and Drug Administration (FDA) regulates activities associated with blood donation. One FDA policy concerns the deferral period of blood donation by men who have sex with men (MSM), and their sexual partners. The policy risks reinforcing stigma against people in the lesbian, gay, bisexual, transgender, queer/questioning (LGBTQ) community. The 2019 novel coronavirus pandemic created an urgent need for blood products; hence, the FDA shortened the deferral period for MSM and their sexual partners. Yet, the public’s support of the deferral policy remained unclear. U.S. community adults (N = 829, Mage = 46.83, 50.3% women, 9.5% lesbian, gay, bisexual (LGB) individuals) rated their approval of the FDA’s deferral policy and attitudes toward blood donations from people across various sexual orientations and gender identities. Approximately 78% of participants reported positive attitudes toward receiving blood from heterosexual donors, whereas 54% reported positive attitudes toward receiving blood from LGBTQ donors. Participants were inclined to believe that the 2020 policy revision was motivated by an increased demand for blood donations amid the coronavirus pandemic rather than an intent to reduce discrimination. Relative to LGB participants, heterosexual participants were less willing to receive blood from LGBTQ donors, more likely to endorse the FDA’s deferral policy, and less likely to consider this policy to be discriminatory. Grounded in a minority stress framework, understanding public opinion can contextualize the possible negative impact on LGBTQ health and inform future FDA policies.

Background and ObjectivesGay and bisexual men (GBM) are deferred from donating blood in many countries. Perceptions by GBM that blood donor deferral policies are unjustifiably discriminatory, especially due to advances in HIV prevention, could contribute to non‐compliance and need to be understood. We explore blood donation interest and history among GBM and attitudes towards donor deferral policies for the first time in New Zealand (NZ).Materials and MethodsData from a cross‐sectional online survey of GBM in NZ were examined. We constructed three groups: (1) never donated blood and not interested; (2) never donated but expressed interest; and (3) previously donated blood. We tested these for association with demographic and behavioural variables, as well as attitudes towards blood donation policy.ResultsA total of 607 GBM were eligible for the study, of whom 32.9% reported having donated blood previously, 44.3% had never donated blood but expressed interest and 22.7% expressed no interest in donating. Among previous donors, a third (8.6% of the total sample) reported non‐compliance with the deferral policy. Most participants found the 12‐month deferral policy to be too strict (81.8%), unfair (75.4%) and homophobic (68.8%).ConclusionWe estimate that, for the first time in NZ, almost 10% of the sample did not report compliance with the 12‐month deferral policy for men who have sex with men (MSM). Negative attitudes towards the deferral policy were common and could potentially increase the risk to the blood supply if compliance reduces. Further work is needed to inform a deferral policy that is accepted by GBM while maintaining the safety of NZ's blood supply.

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British chef and food activist Jamie Oliver ignited a firestorm in January 2011 when he mentioned on the Late Show with David Letterman that castoreum, a substance used to augment some strawberry and vanilla flavorings, comes from what he described as “rendered beaver anal gland.”1 The next year, vegans were outraged to learn that Starbucks used cochineal extract, a color additive derived from insect shells, to dye their strawberry Frappuccino® drinks2 (eventually, the company decided to transition to lycopene, a pigment found in tomatoes3). Although substances like castoreum and cochineal extract may be long on the “yuck factor,”4 research has shown them to be perfectly safe for most people; strident opposition arose not from safety issues but from the ingredients’ origins. But these examples demonstrate that the public often lacks significant knowledge about the ingredients in foods and where they come from. This is not a new development; the public relationship to food additives has a long history of trust lost, regained, and in some cases lost again. The Federal Food, Drug, and Cosmetic (FD&C) Act of 19385 was passed shortly after the deaths of 100 people who took an untested new form of a popular drug, which contained what turned out to be a deadly additive.6 The new law was consumer oriented and intended to ensure that people knew what was in the products they bought, and that those products were safe. The law has been amended over the years in attempts to streamline and bring order to the sprawling task of assessing and categorizing the thousands of substances used in foods, drugs, and cosmetics. One result of this streamlining is that under current U.S. law, companies can add certain types of ingredients to foods without premarket approval from the thin-stretched Food and Drug Administration (FDA). In other words, there are substances in the food supply that are unknown to the FDA. In 2010 the Government Accountability Office (GAO) concluded that a “growing number of substances … may effectively be excluded from federal oversight.”7 Is this a problem? The answer depends on whom you ask.

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …

The US Food and Drug Administration (FDA) is a remarkable hybrid. Part regulatory agency, part public health agency, it sits at the intersection of science, law, and public policy. The FDA’s mission can be considered in the context of 2 broad dimensions: the products it regulates and its core functions. Both fall under the rubric of protecting and promoting the public health. The FDA’s remit is both broad and diverse: altogether, the agency has regulatory responsibility for >20% of the US economy. The products it is charged with overseeing through its various centers1 encompass food and cosmetics (regulated by the Center for Food Safety and Applied Nutrition); food and drugs for animals, including companion animals and animals used for food (regulated by the Center for Veterinary Medicine); and medical devices, drugs, and biologics (regulated by the Centers for Devices and Radiological Health, Drug Evaluation and Research, and Biologics Evaluation and Research, respectively). Tobacco products were added to the FDA’s portfolio by the Tobacco Control Act of 2009, and are overseen by the Center for Tobacco Products. Regardless of the specific product regulated, the FDA’s core mission remains the same: to protect the US population by helping to ensure the fundamental safety of the food Americans consume and the medical products prescribed by their clinicians. At the same time, this primary mission is complemented by a mandate to promote the public health by reviewing research and taking appropriate action on the marketing of regulated products in a timely manner. Not only do people need access to advances in nutrition and medical therapies, but also the American spirit is itself characterized by a strong current of scientific and technological innovation. At first glance, differences in these 2 priorities, protecting the public safety and promoting the public health through encouraging innovation, might …

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