America First Legal (AFL) is suing the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) for failing to turn over documents related to the government’s suppression of the COVID-19 treatments hydroxychloroquine (HCQ) and ivermectin.
According to the lawsuit, AFL filed a Freedom of Information Act (FOIA) request in August 2022 with HHS and the FDA seeking information about the anti-malarial drug HCQ from March 1 to Sept. 1, 2020. AFL received confirmation and tracking numbers from both agencies that its request had been received.
AFL filed similar FOIA requests in September 2022 with the same agencies seeking information on ivermectin—a popular antiparasitic medication—and also received confirmation that the requests were received, along with tracking numbers.
AFL, a nonprofit “working to promote the rule of law in the United States, prevent executive overreach, and ensure due process and equal protection for all Americans,” sought information to determine when and why government officials, including Dr. Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases, discouraged and suppressed the use of HCQ and ivermectin to treat COVID-19.
Neither agency complied with the requests.
“The true reasons for the federal government’s assault on HCQ and ivermectin have never been made public. We don’t know why—in the midst of a pandemic—the government went after doctors prescribing these potentially useful drugs and coerced pharmacies into rejecting prescriptions. But AFL will keep fighting to see that the truth about Dr. Fauci and his colleagues is exposed,” Reed D. Rubinstein, AFL’s senior counselor and director of Oversight and Investigations, said in a press release.
Despite hundreds of peer-reviewed studies supporting the effectiveness of both medications, the FDA has cautioned against using HCQ and ivermectin to prevent and treat COVID-19. On its website, the FDA states that “currently available data do not show ivermectin is effective against COVID-19,” yet half of the studies the agency uses to support its position support using ivermectin against COVID-19, according to a 2022 review by The Epoch Times.
In September, the 5th Circuit Court of Appeals revived a lawsuit against HHS and the FDA filed by three doctors who claimed the FDA overstepped its authority when it initiated an anti-ivermectin public relations campaign in 2021 that warned people not to take the drug.
According to the lawsuit, the FDA released an informal consumer update 18 months into the pandemic discouraging the use of ivermectin to prevent and treat COVID-19. It then released a document on COVID-19 and ivermectin intended for animals and made four posts online—one on its website and three on social media featuring an image of a horse that stated the following:
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
“You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.”
“Hold your horses y’all. Ivermectin may be trending, but it still isn’t authorized to treat COVID-19.”
In an internal email, a member of the FDA’s communications team said the posts were part of a “new engagement strategy.” According to the lawsuit, the national media ran with headlines, and pharmacies, hospitals, and medical boards took notice of the FDA’s position and began restricting access to the treatment and punishing doctors who utilized the treatments for their patients.
The FDA also sent letters to the Federation of State Medical Boards and the National Association of Boards of Pharmacy warning against using ivermectin to treat COVID-19, along with an advisory that said taking it in high dosages was dangerous.
Similar to ivermectin, the FDA cautioned against the use of hydroxychloroquine for the treatment of COVID-19, citing a risk of “heart rhythm problems” and claimed the medication was neither safe nor effective for treating or preventing COVID-19. The agency had previously allowed its use under emergency use authorization (EUA) but revoked the authorization in June 2020—six months before granting EUA to COVID-19 vaccines by Pfizer and Moderna.
A month after revoking EUA for hydroxychloroquine, Dr. Fauci, the former White House coronavirus advisor, said in an interview with MSNBC that scientific data and clinical trials “that were valid” determined that “hydroxychloroquine is not effective” in treating COVID-19.
As stated on the FDA website, the FDA can use its authority to grant EUA under section 564 of the Federal Food, Drug, and Cosmetic Act to allow the use of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met. One of the criteria is that there are no “adequate, approved, and available alternatives.” Thus, to grant EUA to COVID-19 vaccines, no adequate, approved, and available alternative treatment for COVID-19 could exist.