Breaking Down the Barrier to Life-Saving Medications

Naples, FL. - July 1, 2025

On June 26, 2025, Dr. Simone Gold and America’s Frontline Doctors filed two Citizen Petitions with the U.S. Food and Drug Administration (FDA) to convert both hydroxychloroquine and ivermectin from prescription-only status to full over-the-counter (OTC) status. Dr. Gold and AFLDS were joined by doctors Dana Granberg-Nill, Bryan Atkinson, Pierre Kory, Brian Tyson, Peterson Pierre, Robin Armstrong, Geoff Mitchell, and Lynn Fynn as co-petitioners. By submitting these petitions to the FDA, AFLDS is taking critical action to empower the American people and ensure easy access to life-saving medications.

Hydroxychloroquine (HCQ) has been FDA-approved for decades and is available OTC in many parts of the world, such as in Africa and South America, for the prevention and treatment of malaria. In the United States and other Western Nations, HCQ is a widely prescribed medication primarily used to treat rheumatoid arthritis and lupus. According to the government’s own database, FAERS (FDA Adverse Event Reporting System), HCQ is one of the safest drugs on the planet. Ivermectin is a wide-ranging antiparasitic agent that has been used in humans for over three decades and won the Nobel Prize in Medicine in 2015, reflecting the drug's enormous impact on human health. Considered extremely safe, ivermectin is FDA-approved to treat threadworm infection and river blindness, with millions of treatments administered in global public health campaigns. Although it is used to treat parasites, ivermectin has gained much attention for its potential use in cancer treatment. There is absolutely no dispute that both of these drugs are extremely safe.

The COVID pandemic sparked a tremendous public health demand to repurpose well-known drugs like HCQ and ivermectin for new uses, specifically for the prevention and treatment of COVID-19. Tragically, patients who were prescribed these medications by their doctors were denied access by pharmacies that refused to fill these prescriptions due to pressure from government health agencies and their C-suite executives. This unnecessary barrier prevented countless Americans from accessing safe and effective medication in the middle of a pandemic. To make matters worse, both drugs were attacked relentlessly in order to push experimental mRNA injections onto the public. Despite their tremendous safety profiles and potential, these generic medicines are not profitable to Big Pharma, so there is no financial incentive to convert them to OTC status. In short, profits are being prioritized over cheaper alternatives.

Recognizing the importance of cutting through the COVID propaganda and removing this barrier to patient access, Dr. Gold and AFLDS filed a Citizen Petition with the FDA to make HCQ available OTC in October 2020. By refiling our petition for HCQ along with a new petition for ivermectin, we are reactivating this fight. The American people deserve access to safe and effective medicine without government interference!

In a statement following the submission of these petitions, AFLDS Founder and President Dr. Simone Gold stated, “The fight to make hydroxychloroquine and ivermectin over-the-counter continues. The mainstream narrative has collapsed under the weight of its own deception, and the truth can no longer be suppressed. It is way past time for our government to truly follow the science. These drugs are FDA-approved, safe, and life-saving. This isn’t just about COVID or the next pandemic. This is about prioritizing patient access to safe and effective treatment over Big Pharma’s profits. Breaking down the barrier to hydroxychloroquine and ivermectin will save lives. The fight for medical freedom isn’t over. We are calling on the FDA to take critical action now.”

Dr. Geoff Mitchell added, “We suggest that one of the predominant reasons for the poor clinical outcomes and excess COVID deaths in the U.S. was the prohibition of early, oral, outpatient treatment with safe, effective, repurposed drugs like the Nobel-prize-winning IVM and also HCQ. The FDA led the charge against these treatment alternatives, enlisting pharmacists, corporate pharmacies, and physicians in their effort as well. They were effectively banned in the U.S. to enable the release of the COVID vaccine via the Emergency Use Authorization, which required that there be no viable existing alternative therapies. We might say that the FDA defamed half of America’s citizens with ‘you are not a horse.’ It seems that 78 million Americans voted for a change in their healthcare.” 

America’s Frontline Doctors is asking the American people to join us in the fight. We strongly encourage you to learn more HERE and sign our petition TODAY!

Stay tuned - We will keep you updated on our progress and efforts to make HCQ and ivermectin over-the-counter nationwide.

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About AFLDS

We are the Nation's independent authority on ethical and transparent standards in science, health, and human rights. We provide individuals with unbiased and accurate information from the world's top experts in medicine and law so you can be empowered with facts to protect your rights, take care of your health, and safeguard your future. Visit AFLDS.org

Media Contact Lisa Alexander, Communications Director | Media@AFLDS.org