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FDA guidance eases blood donation restrictions for gay, bi men

Sen. Tammy Baldwin, Congressional LGBTQ+ Equality Caucus, LGBTQ groups celebrate new FDA proposal

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FDA headquarters (Public domain photo.)

The U.S. Food and Drug Administration (FDA) introduced a proposed change to its blood donation guidelines on Friday that would ease restrictions for gay and bisexual men.

The FDA notes the proposal, news of which was first reported in November, would bring U.S. policies in alignment with those in place in countries like the U.K. and Canada. The agency is expected to formally adopt the new guidelines after a public comment period.

The move follows criticism from LGBTQ groups and organizations like the American Medical Association (AMA) that have long argued the current policy is homophobic and based on an outdated understanding of the risks associated with blood donation by men who have sex with men.

As the AMA wrote of the current policy: “a man who has protected sex with another man in the three months prior to a blood donation cannot be a donor, but a man or woman who has unprotected sex with multiple partners of the opposite sex over the same time period remains eligible.”

The FDA’s proposal would lift the mandatory three-month deferral period for some men who have sex with men and instead use a “gender-inclusive, individual risk-based questions relevant to HIV risk.”

Potential donors would be asked for information about their sexual history over the past three months. Respondents who indicate they have had sex with one or more new sexual partners would then be asked whether they have had anal sex during this period. Those who answer “yes” would be deferred from blood donation.

Axios noted that as of this morning, about 20 percent of the country’s community blood centers have a one-day supply or less, while the FDA’s broadened eligibility criteria would increase the annual blood supply by two to four percent, citing data from America’s Blood Centers’ daily tracker and the Williams Institute.

U.S. Sen. Tammy Baldwin (D-Wis.) issued a statement celebrating the FDA’s proposal. “As I have long advocated for, this blood donation policy takes a step forward and is better rooted in the most up-to-date science with a focus on individual risk factors, not outdated stigmas that effectively ban gay and bisexual men,” she said.

Baldwin has repeatedly urged the agency to revisit its blood donation policy over the years, including by corralling support from other members of Congress to cosign letters to the FDA in 2014 and 2016, raising the issue again in 2020 as the COVID-19 pandemic exacerbated shortages in the blood supply.

The Congressional LGBTQ+ Equality Caucus also acknowledged the move in a statement by its chair, Rep. Mark Pocan (D-Wis.): “I am glad the FDA is finally moving toward an individual risk-based assessment model, but recognize, based on existing reporting, that many LGBTQI+ people may still be barred from donating,” he said. “I look forward to taking a closer look at the proposed guidelines once they are published and working with the FDA to ensure that any unnecessary barriers are removed.”

Several LGBTQ groups also issued statements celebrating the FDA’s new guidance.

“These changes are 40-plus years in the making, and are a tremendous leap forward toward elevating science over stigma,” said GLAAD President Sarah Kate Ellis. “GLAAD and leading medical experts have long been advocating for guidelines that see and treat LGBTQ people the same as any other person, including as potential donors who want to help others.”

“This new policy removes a decades-long barrier for many in our community – and there is more to do to ensure gay, bisexual and transgender people are no longer unfairly stigmatized when they try to donate blood,” Human Rights Campaign President Kelley Robinson said. “The assessment criteria have flaws, focusing excessively, for instance, on the number of partners a potential donor has instead of just on new partners,” she added.

Carl Schmid, executive director of the HIV+ Hepatitis Policy Institute, said: “While this long-overdue change is being made based on the science and the facts, which have been clear for years, it is the result of the leadership of the Biden administration that continues to tear down discriminatory government policies.”

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Office of National AIDS Policy Director Phillips: Congress must increase funding

‘Without congressional funding we can’t get there’

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The White House in 2011 (Washington Blade photo by Michael Key)

Harold Phillips, director of the White House Office of National AIDS Policy (ONAP), said Monday that Congress must increase funding to end the HIV/AIDS epidemic, including for programs designed around the lives and needs of Americans who are living with the disease.

“We have the support of the Biden-Harris administration, and we have the support at HHS, but without congressional funding we can’t get there,” said Phillips, who delivered his remarks during the AIDS United annual AIDSWatch conference in Washington, D.C.

Phillips echoed remarks by other speakers in calling for Congress to increase appropriations funding for the U.S. Department of Health and Human Services (HHS) Ryan White HIV/AIDS Program, but he also emphasized the importance of “making space for people living with HIV in other aspects of the budget.”

Consistent with the Biden-Harris administration’s focus on employing a whole-of-government approach, Phillips said stakeholders must understand that while “HIV is, yes, a public health threat,” the disease is also “the result of systemic and structural racism,” an intersectional problem requiring more than narrowly focused biomedical or public health responses.

Therefore, he said, these conversations about matters like HIV’s impact on Black lives, or considerations for aging folks who are living with the disease, must be held at places like the White House Gender Policy Council, the National Economic Council, and the U.S. Department of Labor.

“When we talk about ending HIV as a public health threat,” Phillips said, “we also want to end HIV such that it’s not the defining characteristic for people living with HIV and that they can have access to housing, access to employment, good mental health and substance abuse treatment.”

Former ONAP Director Sandra Thurman with ONAP Director Harold Phillips (Screen shot/YouTube)

Under Phillips’s leadership, data on these considerations for those living with HIV/AIDS will be measured for the first time with ONAP’s rollout of new quality of life indicators in the National HIV/AIDS Strategy Federal Implementation Plan.

“There’s an indicator in there that’s self-reported quality of life,” Phillips said, which asks respondents to consider, “how do I feel?” This is important, he added, because people living with HIV may have positive lab results but still feel poorly.

Phillips advised those AIDSWatch participants who are slated to meet with members of Congress and their staffs after hosting a rally on the grounds of the U.S. Capitol Tuesday morning to “build a common bond” with lawmakers by emphasizing the human impact of the appropriations funding for which they are advocating.

An AIDS United spokesperson told the Washington Blade by email Monday that 187 congressional meetings have been scheduled for Tuesday.

Phillips also noted that while “conversations need to happen in Washington, there’s also conversations that need to happen on the state and local level,” where “we’re finding a level of hate and stigma and discrimination that’s on course to try to either stop our progress or take us backwards.”

Speaking before Phillips, Equality Federation Public Health Policy Strategist Mike Webb stressed the importance of policies under consideration by state and local lawmakers. “Our access to PrEP shouldn’t be based on a patchwork of laws by the states,” they said, and HIV-related legislative proposals in many cases would “add criminalizing aspects.”

Laws already on the books that “criminalize the transmission of, or perceived exposure to, HIV and other infectious diseases,” the Movement Advancement Project writes, “create a strong disincentive for being tested for HIV, and result in adverse public health outcomes.”

Phillips and the Biden administration have made modernizing or repealing those laws a top priority.

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Biden budget earmarks funds for HIV along with new programs for PrEP, hepatitis C

Budget seen as preview of Biden’s reelection campaign

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The White House in 2011 (Washington Blade photo by Michael Key)

The $6.8 trillion budget unveiled by President Joe Biden on Thursday includes increased investment in existing programs to fight HIV/AIDS, along with new initiatives to expand access to HIV prevention medications and eliminate hepatitis C.

U.S. House Republicans are expected to kill the proposal, which is nevertheless seen as a possible blueprint for the major themes to come in Biden’s expected reelection campaign.

Major focus areas of the plan include deficit reduction, increased taxes for the wealthy, and increased spending on the military and other endeavors to compete with China.

The HIV + Hepatitis Policy Institute praised the budget in a press release Thursday, writing that it will “significantly increase the federal resources necessary to end both HIV and hepatitis C.”

The group’s president, Carl Schmid, said Biden “recognizes the historic role the federal government must play, and the investments needed to end infectious diseases.”

First, the plan would bolster funding for the Trump-era Ending the HIV Epidemic in the United States initiative by $313 million, bringing the total to $850 million. Second, it would debut a “ten-year $9.7 billion nationwide PrEP delivery program” and a “historic initiative to eliminate hepatitis C.”

PrEP, or preexposure prophylaxis, is a medication regimen that reduces the risk of contracting HIV. According to the HIV + Hepatitis Policy Institute, only 30 percent of patients who could benefit from the drug are taking it.

The new hepatitis C program “seeks to provide outreach, testing, and curative medications to the estimated 2.4 million people living with hepatitis C, many of whom are unaware of their infection.”

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Gov. Newsom: Calif. will not do business with Walgreens after decision to not distribute abortion pill

20 Republican state attorneys general threatened to sue Walgreens for offering mifepristone

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Calif. Gov. Gavin Newsom (D) (Washington Blade file photo by Michael Key)

Gov. Gavin Newsom (D-Calif.) announced on Monday that California will not do business with Walgreens following the company’s announcement of its decision on Friday to not distribute the abortion pill mifepristone in 20 states.

The move comes amid pressure from conservative lawmakers and threats of legal action against Walgreens and CVS from 20 Republican state attorneys general, who claimed in a Feb. 1 press release that selling mifepristone is “unsafe and illegal.”

Mifepristone is still legal in several of the states where Walgreens has decided to stop providing it in response to the specter of lawsuits from state attorneys general: Alaska, Iowa, Kansas and Montana.

Newsom’s office told NPR that California will review “all relationships between Walgreens and the state,” but declined to provide more specifics.

“California won’t be doing business with @walgreens – or any company that cowers to the extremists and puts women’s lives at risk,” Newsom wrote in the tweet. “We’re done.”

“Elected officials targeting pharmacies and their ability to provide women with access to safe, effective, and FDA-approved medication is dangerous and just unacceptable,” White House Press Secretary Karine Jean-Pierre said during a briefing on March 3.

“The administration will continue to stand by the FDA’s expert judgment in approving and regulating medications. And in the face of barriers to access and concerns about safety of patients, healthcare providers, and pharmacists, we will continue to support access to this critical medication within the limits of the law,” Jean-Pierre said.

Meanwhile, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas is expected to soon rule on a case challenging the safety of mifepristone that advocates for reproductive justice fear could lead to a nationwide injunction prohibiting the sale and distribution of the abortion drug.

Medical experts have slammed the Texas plaintiffs’ lawsuit, arguing that mifepristone’s safety and efficacy have been well demonstrated for years. Kacsmaryk, who was appointed by former President Donald Trump, is nevertheless expected to rule in their favor.

“The plaintiffs who have no legitimate standing have hand-picked him to hear this case that has no merit because they know what they’re getting with Judge Kacsmaryk,” Sen. Ron Wyden (D-Ore.) said last month.

Jean-Pierre addressed the case during a press briefing on March 1: “The decision would be unprecedented, as you know, and devastating to women’s health.  And we may find ourselves in uncharted territory,” she said.

“And so, we’re closely — closely working with the Justice Department and DHS — HHS on this, on how to be prepared for any range of outcome or potential outcomes,” Jean-Pierre added.

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