New Draft FDA Blood Screening Guidance Undermines PrEP and Condom Use

At first glance, the U.S. Food and Drug Administration’s proposed major policy shift for screening blood donations for HIV appears to finally lift the discriminatory and stigmatizing ban against donations from gay, bisexual, and other men who have sex with men (MSM), unless they’ve been sexually abstinent for three months.

However, GMHC is raising serious concerns about how the new policy could undermine public faith and confidence in condom use and PrEP (pre-exposure prophylaxis), which are fundamental safer sex practices for HIV prevention.

Under the current policy, MSM are the only group of people singled out for the three-month deferral simply because of who they are. GMHC has been fighting this discriminatory ban for decades—along with other HIV/AIDS and LGBTQ+ organizations, the American Red Cross and other U.S. blood centers, and the American Medical Association—because it falsely stigmatizes MSM as carriers of a “gay disease.”

In draft guidance released January 27, the FDA is proposing an across-the-board behavioral-based approach for the individual donor history screening questionnaire in place of questions that currently focus on sexual orientation. Donors would continue to be screened out for participating in commercial sex work or injection drug use, which increase the risk of exposure to HIV. People living with HIV also can’t donate blood.

While the FDA is proposing a policy that is ostensibly more science-based for assessing HIV risk, its updated guidance raises concerning issues for condom and PrEP usage

First, anyone who reports having anal sex with a new sex partner or multiple sex partners in the previous three months—even if they use condoms—would be screened out under the new guidelines. Any prospective donor answering affirmatively to those questions would be deferred for three months.

People taking PrEP would also be deferred, even though this medication is over 99% effective for preventing HIV. People taking daily PrEP pills would be deferred for three months after their most recent dose, while those receiving bimonthly, long-term PrEP injections would be deferred for two years from their most recent injection.

Condoms and PrEP

Using condoms and taking PrEP are two of the most effective methods we have for preventing HIV—but the FDA’s new guidance would discount condom usage as a safer sex practice for anal sex and prevent people on PrEP from giving blood unless they suspend their PrEP regimen.

The FDA itself recognizes the value of taking PrEP, which it approved for HIV prevention over a decade ago: In announcing the new screening guidelines, it says people should not stop taking PrEP in order to donate blood. In fact, for HIV prevention, the FDA recommends PrEP and condom usage, along with regular HIV testing, other STI testing and treatment, and counseling on safer sex practices.

Encouraging the use of condoms and PrEP—both highly effective HIV prevention tools–is central to our mission at GMHC, as well as for other HIV and AIDS service organizations. Turning people away from giving blood—even if they’re using a condom for anal sex or are on PrEP—sends a message that is counterproductive and confusing.

GMHC’s vice president of policy and communications, Jason Cianciotto, told the San Francisco Chronicle that these restrictions carry their own stigma: “How do I message this in a way that doesn’t come across as gay and bisexual men are still inherently diseased? Or that the way we have sex is somehow inherently bad?” he asked.

To justify its deferral policy for PrEP usage, the FDA cites nascent research that indicates it is possible for someone on PrEP who’s been exposed to HIV to have such a low level of virus in their blood that it’s not detectable by current blood screening tests, resulting in a false negative.

However, all blood donations are screened for HIV by both an antigen test for HIV antibodies and a highly sensitive nucleic acid test that can detect the actual virus within 10 to 33 days of exposure, according to the Centers for Disease Control.

What’s more, when these tests are employed, the FDA itself places the per-unit risk of HIV infection from a blood transfusion at about one in 1.47 million. For comparison, the odds of dying in a car crash are one in 101, according to the National Safety Council.

For this reason, the FDA should reduce the screening period from three months to 45 days for people who’ve had anal sex with new or multiple partners. That would amply cover the period from any HIV exposure to when a nucleic acid test can detect HIV in blood. 

We also urge the FDA not to defer individuals solely for taking PrEP. Further, it should add screening questions that take into account protective sex practices, including condom and PrEP use.

Safer Sex Behaviors

The FDA’s stated goal is to continue to reduce the risk of blood-borne HIV transmission in the nation’s blood supply—a goal we fully support. However, to ensure the safety of the blood supply, it is a serious error to use behavioral questions that focus solely on anal sex as an indicator of high-risk sexual behavior.

While HIV is more easily transmitted during anal sex, many women become infected via vaginal intercourse. In fact, of the more than 1.1 million people living with HIV in the U.S., 23% are women. 

Is the risk of HIV exposure via safer anal sex, such as using PrEP or a condom (or both), truly higher than the exposure risk for someone engaging in vaginal sex with multiple new partners who does not take these safer sex precautions?

With these new guidelines, the FDA continues to perpetuate homophobic stigma by introducing a de facto ban on blood donors who are MSM In practice, the FDA’s proposed new guidelines only enable MSM in longer term, monogamous relationships to donate blood, while all other MSM would be deferred until they abstained from anal sex for three months.

To protect the nation’s blood supply, the sexual risk assessment questions must instead focus on all prospective donors–not just people having anal sex—who have not practiced safer sex by using PrEP and condoms during the 10- to 33-day window for which modern testing cannot detect the presence of HIV in blood.

Donor screening questions about higher-risk sexual behavior should address all sexual activity that creates risk for HIV transmission. That would make the screening tool more effective and avoid stigmatizing—yet again—MSM. Otherwise, the FDA will again communicate an inaccurate, unscientific message about how HIV is transmitted that continues to perpetuate homophobia.

The FDA is holding a 60-day public comment period through March 31 about the draft blood-screening questions. Use this link to comment online. To comment by mail, refer to the agency’s notice published in the Federal Register and use docket number FDA-2015-D-1211.