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Restrictions on blood donations eased; limitations lead to controversy
by Matt Simonette
2015-12-21

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While key limitations still apply, the Food and Drug Administration (FDA) announced Dec. 21 that it was easing some restrictions on blood donations from gay and bisexual men.

Previous restrictions, which had been in place for about 32 years, included a "lifetime deferral" for gay and bisexual men, meaning any men who had ever had sex with men since 1977 were prohibited from making donations. Under new rules, only men who have not had sex with men in the previous 12 months will be prohibited from doing so.

"In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment," said Peter Marks, M.D., deputy director of the FDA's Center for Biologics Evaluation and Research, in a statement. "Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge."

While the FDA regards the shift as a progressive step in the right direction, many advocates and stakeholders have regarded even the one-year ban as an overreach that contributes to stigmatization against gay and bisexual men and HIV-positive individuals.

U.S. Rep. Mike Quigley (D-Illinois), vice-chair of the Congressional LGBT Equality Caucus, said in a statement, "This past year, we saw tremendous progress for the LGBT community with the legalization of same sex marriage nationwide. Unfortunately, today's official policy change by the FDA on blood donations from men who have sex with men (MSM) from a lifetime ban to one-year deferral does not keep up with that same progress. A time-based deferral focusing solely on men who have sex with men is still discriminatory and fails to exclude donors based on actual risk factors. However, I remain encouraged by the ongoing conversation to change this outdated policy."

U.S. Sen. Tammy Baldwin (D-Wisconsin), added, "I am encouraged that the FDA swiftly finalized this guidance to move forward and revise the discriminatory lifetime ban on blood donations. However, this is just the first step toward ending an outdated policy that is medically and scientifically unwarranted. This revision doesn't go far enough—and I expect the FDA to maintain its commitment to work with stakeholders to develop better blood donor policies based on science."

Scott Schoettes, Lambda Legal senior attorney and HIV Project director, said in a statement, "We are glad that the proposed new guidelines allow a subset of gay and bisexual men who have abstained from sex for a year to donate, and we are pleased transgender people will be allowed to self-report their gender in the donation process, but the policy still excludes the vast majority of gay, bisexual and transgender men from donating."

"The United States government has to stop reacting to HIV like it is the early 1980s," added Gay Men's Health Crisis CEO Kelsey Louie. "Other countries have implemented risk-based deferral systems that reflect modern science and screen all donors for behavior that could lead to HIV transmission. ... It is time for the FDA to implement a policy that is truly based on science, not blanket bans on certain groups of people."

BELOW FROM PRESS RELEASES

Quigley responds to FDA policy change to blood donor deferral policy for MSM

WASHINGTON — Today, U.S. Representative Mike Quigley (IL-05), Vice-Chair of the Congressional LGBT Equality Caucus, released the following statement regarding the Food and Drug Administration's (FDA) policy change of the blood donor deferral policy for men who have sex with men (MSM) from lifetime ban to one-year deferral:

"This past year, we saw tremendous progress for the LGBT community with the legalization of same sex marriage nationwide. Unfortunately, today's official policy change by the FDA on blood donations from men who have sex with men (MSM) from a lifetime ban to one-year deferral does not keep up with that same progress. A time-based deferral focusing solely on men who have sex with men is still discriminatory and fails to exclude donors based on actual risk factors. However, I remain encouraged by the ongoing conversation to change this outdated policy. As the leader of the bipartisan, bicameral effort to reverse the FDA's discriminatory policy, I will continue to fight for a deferral policy based on behavioral risks, commensurate with the rest of the population and based on sound science, bringing equality for the LGBT community while still protecting the U.S. blood supply."

The previous lifetime ban on MSM donating blood was put in place during the rise of the AIDS epidemic in the 1980's, but is no longer scientifically justified with current blood screening technology. In 2010, the HHS Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA) found the ban to be suboptimal and asked for re-evaluation of this policy. In response to a letter from legislators in 2013, HHS indicated that the Department will finish deliberations on a policy change to the blood ban by the end of 2014.

In 2013, the American Medical Association (AMA) passed a resolution opposing the current lifetime ban as discriminatory and not based on sound science. Instead, the AMA supports new donation deferral policies that are based on an individual's level of risk. The blood banking community, including the American Red Cross and America's Blood Centers, has also long-supported a change in policy.

Rep. Quigley has been a leader in the fight to change this outdated and discriminatory policy. This summer, along with 79 of his congressional colleagues, Rep. Quigley sent a letter to the FDA requesting that the FDA implement the one year deferral policy "in a way that ensures that this is only a first step toward implementing a risk-based blood donation policy for MSM," and requests that the agency consider amending the draft guidance document to clarify the agency's policy regarding donations from transgender individuals, to clearly delink the establishment of the Transfusion Transmissible Infections Monitoring System from the change in the MSM blood donation policy, and to take action to reform and correct deficiencies in the Uniform Donor History Questionnaire. Last year in a letter to HHS Secretary Sylvia Burwell, Rep. Quigley, along with 75 of their colleagues, asked for additional information regarding the timeline for reversing the lifetime deferral policy, actions being taken to work towards a risk-based deferral policy, and plans for implementing the long-overdue blood safety surveillance system. Previously, he urged HHS Secretary Burwell to reevaluate the current discriminatory, inconsistent blood, organ and tissue donation policies for MSM.

Gay Men's Health Crisis responds: FDA's 12-month deferral discriminatory

New York, NY - Today the FDA formally released a 12-month deferral plan in the blood donation policy for gay and bisexual men, clinically referred to as "men who have sex with men" (MSM). The policy replaces a lifetime ban on gay and bisexual male blood donors with a one-year deferral for any man who has had sex with another man - meaning, gay and bisexual men must be celibate for one year before they can donate blood.

The following is a statement from Kelsey Louie, GMHC's CEO:

The FDA's 12-month deferral plan would still require gay and bisexual men to be celibate for a full year before they are allowed to donate blood, regardless of marital status and safe-sex practices. Heterosexuals are given no such restrictions, even if their sexual behavior places them at high risk for HIV. In practice, the new policy is still a continuation of the lifetime ban and ignores the modern science of HIV-testing technology while perpetuating the stereotype that all gay and bisexual men are inherently dangerous. Blood donation policies should be based on science, not stigma.

The United States government has to stop reacting to HIV like it is the early 1980s. Other countries have implemented risk-based deferral systems that reflect modern science and screen all donors for behavior that could lead to HIV transmission. Since Italy implemented this type of system in 2001, transfusion-related infections have actually decreased.

It is time for the FDA to implement a policy that is truly based on science, not blanket bans on certain groups of people. GMHC is optimistic that we can and should get to a policy that will treat gay people who want to donate blood with the dignity and respect they deserve.

This is why GMHC is proud to participate in a campaign for #BloodEquality, a bold advocacy campaign launched to stop the discrimination against prospective donors and allow everyone an equal opportunity to donate blood.

More information on the Blood Equality campaign can be found at www.Blood-Equality.com .

About Gay Men's Health Crisis

Gay Men's Health Crisis (GMHC) is the nation's leading provider of HIV and AIDS care, prevention services and advocacy, serving nearly 9,000 people living with and affected by HIV and AIDS in New York City, the epidemic's largest U.S. epicenter. As the world's first HIV and AIDS service organization, GMHC is an expert in providing services that every person affected by the epidemic deserves. GMHC is on the front lines caring for people who are both HIV negative and positive, including: testing, nutrition, legal, mental health and education services. GMHC also advocates for stronger public policies at the local, state and federal level with the goal of ending AIDS as an epidemic in New York State by 2020. Most recently, GMHC and other HIV and AIDS organizations successfully persuaded the federal government to recommend widespread use of PrEP, a new daily treatment that is over 90% effective in preventing HIV infection. For more information, visit www.gmhc.org .

About the FCB Health Network

With more than 30 years of experience marketing to healthcare professionals, patients and consumers, FCB Health produces work that is both strategically relevant and creatively compelling. The agency provides its clients with multichannel capabilities, including payer strategy and marketing, professional education, scientific services, strategic planning and media services. Its high energy, diverse culture and global network have resulted in a robust client roster, including Abbvie, Onyx, Takeda, J&J, Boehringer-Ingelheim, Bristol-Myers Squibb, Lilly and Novartis. It was named "Agency of the Year" by Medical Advertising News in 2006 and 2009 and by Medical Marketing & Media in 2007 and 2010. For the past four out of five years, FCB Health was named Most Creative Agency by Medical Advertising News.

FCB Health is a unit of FCB, itself a member of the Interpublic Group (NYSE: IPG). Under its network umbrella, FCB Health has other separate full-service, multichannel healthcare agencies, including AREA 23 and Neon, as well as units focusing specifically on managed markets and medical education, Mosaic, ProHealth and Hudson Global. For more information, visit www.fcbhealthcare.com .


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