AVAC Condemns Court Decision that Tramples Human Rights, Endangers Evidence-Based Medical Care and Sets a Dangerous Precedent

As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC strongly condemns the decision by a federal judge in Texas who issued an unprecedented preliminary injunction that suspends the US Food and Drug Administration’s (FDA) approval of mifepristone, a safe and effective abortion medication approved more than 20 years ago. If this decision is allowed to stand, it will restrict access to the most widely used method of abortion and undermine the FDA’s authority on drug regulation generally.

A counter ruling issued shortly after the Texas decision by a judge in Washington state called for the FDA to maintain access to mifepristone. It is unclear how these competing rulings will play out, but it is assumed this will force the issue to the Supreme Court where it is uncertain how a conservative majority may rule.

“The Texas decision throws open the door to reversals of other drug approvals based on one individuals’ personal or political beliefs rather than science and evidence. It’s yet another blow in a campaign to roll back bodily autonomy and human rights and cannot be allowed to stand,” said Mitchell Warren, AVAC’s executive director. “In solidarity, we stand with the millions of individuals and families who will be affected by this highly political decision, and we stand with science and medical evidence, which is increasingly under attack in the US.”

More than 20 years ago, the FDA reviewed the scientific evidence and approved mifepristone for medication abortion as a safe and effective product. In the intervening time, a tremendous amount of additional evidence has been added to the safety and efficacy profile of the drug, and its effective use outside of a clinic setting.

“The FDA’s job is to evaluate reams of scientific evidence and conduct unbiased, stringent review of new drugs and devices.” said Suraj Madoori, AVAC’s director of policy advocacy. “Friday’s ruling would take decision-making out of the hands of experts and put it into the hands of misguided activist judges, endangering access to other FDA-approved medications. AVAC is especially concerned about implications for access to contraception, treatments used by transgender individuals and HIV prevention drugs.”

“The FDA is recognized as the global leader in stringent, objective review of drugs and devices. Today’s ruling not only endangers public health and access to safe, effective medication, it jeopardizes our national standing and well-earned respect for our regulatory body,” said Madoori.

AVAC calls on the Biden Administration to take immediate action to safeguard access to mifepristone and to the sanctity and credibility of the nation’s drug approval process. AVAC also calls for appellate courts and the Supreme Court to uphold the FDA’s jurisdiction over drug regulation.

“This decision cannot be allowed to stand. AVAC commits to working with our partners and allies to ensure that the right to access evidence-based medical care is not infringed and that the right to abortion, and reproductive rights overall, are protected for all,” Warren added.

Challenging a Season of Hate in 2023

A look back at the last few weeks brings a heavy heart, and, for us at AVAC, a renewed determination to fight back against a sea of reactionary policies that jeopardize healthcare and dismantle civil liberties around the world.

As our Executive Director Mitchell Warren recently told the TheBodyPro, “This is, frankly, a global pandemic. Right-wing politics, moralizing legislatures, and moralizing judicial systems are putting people’s lives at risk.”

Extremist courts and legislatures in the US and in many other countries are pursuing laws that will, at the very least, turn back time in our progress against HIV and at worst destroy the lives of whole segments of society.

In the last two weeks alone, AVAC has had to issue three statements condemning unjust, dangerous and deeply flawed legal maneuvers.

On March 24, we condemned Uganda’s Anti-Homosexuality Bill of 2023, a more poisonous version of a 2014 attempt to further criminalize the LGBTQIA+ community. It’s also just one of condemned Uganda’s Anti-Homosexuality Bill of 2023 several draconian anti-gay bills sweeping across Africa and the US. As Brian Kanyemba of Advocacy for Prevention of HIV and AIDS (APHA) told TheBodyPro, it’s a “Homophobic Spring”. (Watch this space for a podcast in the coming days with stunning reports from Uganda-based advocates on the fight against Uganda’s proposed anti-homosexuality law.)

Two US court rulings have since come down, each attacking access to fundamental healthcare. On March 30th, a US federal judge in Fort Worth, Texas, struck down a section of the Affordable Care Act that requires insurance coverage for many preventive services, including HIV testing and the provision of PrEP. This ruling reinforced an earlier decision that ruled PrEP provision may violate individual religious freedom. AVAC’s statement condemned this ruling that endangers access to PrEP, as well as other life-saving prevention services.

And today, we are again condemning a court ruling from a different US federal judge, this time based in Amarillo Texas, who has issued an unprecedented preliminary injunction suspending the US Food and Drug Administration’s (FDA) approval of mifepristone, a safe and effective abortion medication approved more than 20 years ago. If this decision is allowed to stand, it will restrict access to the most widely used method of abortion and undermine the FDA’s authority on drug regulation generally.

“This decision throws open the door to reversals of other drug approvals based on one individuals’ personal or political beliefs rather than science and evidence. It’s yet another blow in a campaign to roll back bodily autonomy and human rights and cannot be allowed to stand,” said Warren. “In solidarity, we stand with the millions of individuals and families who will be affected by this highly political decision, and we stand with science and medical evidence, which is increasingly under attack in the US.”

In what has become a season of hate, we turn our eyes to the work ahead. We call on the Biden administration to take immediate action to safeguard access to every aspect of sexual, reproductive and preventive healthcare, including PrEP, mifepristone and other abortion services. We call on political leaders and health leaders in every corner of the globe to take action in solidarity with LGBTQIA+ people to protect and expand their civil rights. When fear and reaction gather momentum, we must recommit to an advocacy agenda that champions evidence-based and science-informed policy. We must join together, with clarity and solidarity, to face down the hate and build a world for all of us that is safe, healthy and just.

AVAC at the 2023 Biomedical HIV Prevention Summit

The Biomedical HIV Prevention Summit, now in its seventh year, will be held in Las Vegas, Nevada, on April 11-12. This annual meeting focuses on biomedical interventions for treatment and prevention of HIV and approaches to implementation of these tools to end the epidemic.

This year’s theme highlights the role of sex and pleasure and includes a plenary featuring advocacy to right the wrongs of a failed US federal PrEP response with a US National PrEP Program.

AVAC and partners are involved in a number of sessions and activities; scroll down for information on these and click here to check out the full conference agenda.

And finally, be sure to follow our Twitter feed, @HIVpxresearch, Tuesday, April 11, when our Senior Program Manager for Policy, John Meade Jr., takes it over to report on the meeting live from Las Vegas.

AVAC and Partners at the Biomedical Prevention Summit

Tuesday, April 11:

10:30 to 12:00 PM PDT: No Data No More: A research scorecard for transgender inclusion
Session 1 Workshop
If we are to end the epidemic, we need biomedical research data that are representative of transgender communities. AVAC has designed a Scorecard tool with which to hold researchers accountable for the meaningful inclusion of transgender people in all HIV clinical trials. Join this session to learn how milestone HIV studies from 1991-the present have scored on transgender inclusion—and how you can ensure “No Data No More.”

4:30 to 6:00 PM EDT: Long-Acting Injectables: Revolutionary prevention drugs require revolutionary adaptations in delivery
Session 3 Workshop
Current delivery models for longer-acting injectable (LAI) PrEP require consumers to travel to outpatient settings and be seen by providers qualified to deliver injections. Yet, many providers serving HIV-impacted populations do not have sufficient capacity to offer LAI PrEP at the volume necessary to end the epidemic. Additionally, structural barriers and serious inequities within the United States healthcare system prevent many from engaging in HIV prevention. This workshop will explore how the HIV prevention community can draw lessons from other fields to successfully develop, advocate for, and implement alternative delivery models for LAI to increase access, and realize the promise of these revolutionary interventions.

4:30 to 6:00 PM PDT: PrEP in Black America: An equity movement in HIV prevention
Session 3 Workshop
Black people in the US bear a disproportionate burden of HIV, representing approximately 13 percent of the population while comprising more than 40 percent of incident HIV diagnoses in 2019. Despite this, biomedical HIV prevention tools remain underutilized by Black people and more than 90 percent of those who can benefit from PrEP have not been prescribed PrEP. The PrEP in Black America Summit (PIBA) was convened by a cadre of Black HIV activists, advocates, leaders, and public health professionals to address these frustrating factors on the 10th anniversary of the Food and Drug Administration’s approval of the first medication for biomedical HIV prevention. Summit leaders gathered more than 150 individuals, in person and virtual, in the spirit of confronting the historical injustices and race-based discrimination that continue to drive HIV and other sexual health inequities experienced by Black communities to develop a Black-focused agenda or “roadmap” for HIV prevention.

Wednesday, April 12:

10:30 to 12:00 PM PDT: CAB 4 PrEP: Opportunity for advancing equity and improving access
Session 4 Workshop
Injectable PrEP uptake in the US has the potential to reduce HIV infections, but only if its introduction can address the impediments to its implementation. Participants will engage with panelists that have experience with injectable cabotegravir in this workshop.

Webinar Recording on Global PPPR Equity

Global PPPR Equity: Why do we need agreements on IP and tech transfers?

Over the past two decades, HIV advocates have engaged in hard battles for equitable access to HIV/AIDS drugs and prevention options and have had some big wins. The process of these negotiations has led to strong relationships that have enshrined certain equity provisions as standard in clinical trials and manufacturing of HIV drugs. Through these battles, we’ve learned clear lessons on the necessity for such agreements and what’s required to secure them.

Throughout global PPPR agreements in 2023, governments and advocates in the Global South are asking for provisions on equity in the form of temporary IP waivers, mandatory tech transfer, and mandatory licensing for pandemic tools.

This panel discussed lessons from the HIV epidemic and explore why governments of the Global South and advocates think we still need to address ‘the IP question’.

Featured Speakers included Fifa Rahman, Brook Baker, Fitsum Lakew, and Esteban Burrone

Watch the recording here.