Case 3:22-cv-00184 Document 1 Filed on 06/02/22 in TXSD Page 1 of 37
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`IN THE UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF TEXAS
`GALVESTON DIVISION
`
`No. 3:22-cv-184
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`
`
`
`ROBERT L. APTER, M.D., FACEP;
`
`MARY TALLEY BOWDEN, M.D.; and
`
`PAUL E. MARIK, MBBCh, M.MED, FCCM,
`FCCP,
`
`Plaintiffs,
`
`
`v.
`
`DEPARTMENT OF HEALTH AND HUMAN
`SERVICES;
`
`XAVIER BECERRA, in his official capacity as
`Secretary of Health and Human Services;
`
`FOOD AND DRUG ADMINISTRATION; and
`
`ROBERT M. CALIFF, M.D., MACC, in his official
`capacity as Commissioner of Food and Drugs,
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`Defendants.
`
`
`
`COMPLAINT
`
`FOR VACATUR, DECLARATORY, AND INJUNCTIVE RELIEF
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`INTRODUCTION
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`1.
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`The U.S. Food and Drug Administration (“FDA”) is a gatekeeper with authority to
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`“approve” when a drug can be introduced to the market in the United States and what labeling it
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`can use. The FDA generally cannot ban particular uses of human drugs once they are otherwise
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`approved and admitted to the market, even if such use differs from the labeling—commonly
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`referred to as “off-label” use. The FDA also cannot advise whether a patient should take an
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`approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient
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`relationship. Attempts by the FDA to influence or intervene in the doctor-patient relationship
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`amount to interference with the practice of medicine, the regulation of which is—and always has
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`been—reserved to states.
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`2.
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`The FDA breached this critical boundary between federal and state authority by
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`directing the public, including health professionals and patients, not to use ivermectin to treat
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`COVID-19, even though the drug remains fully approved for human use.
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`3.
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`This case is not about whether ivermectin is an effective treatment for COVID-19.
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`It’s about who determines the appropriate treatment for each unique patient and whether the FDA
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`can interfere with that process.
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`4.
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`The FDA has unlawfully taken formal, unequivocal, and conclusory actions to
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`prohibit or otherwise interfere with the use of ivermectin to treat COVID-19, including:
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`a. A publication entitled, “Why You Should Not Use Ivermectin to Treat or Prevent
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`COVID-19.” Ex. 1, Why You Should Not Use Ivermectin to Treat or Prevent
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`COVID-19, FDA (Dec. 10, 2021), https://www.fda.gov/consumers/consumer-
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`updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19.
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`b. A “Frequently Asked Questions” that begins, “Q: Should I take ivermectin to
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`prevent or treat COVID-19? A: No. . . .” Ex. 2, FAQ: COVID-19 and Ivermectin
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`Intended for Animals, FDA (Apr. 26, 2021), https://www.fda.gov/animal-
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`veterinary/product-safety-information/faq-covid-19-and-ivermectin-intended-
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`animals (“Ivermectin FAQ”).
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`c. An August 21, 2021 tweet that reads, “You are not a horse. You are not a cow.
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`Seriously, y’all. Stop it.” Ex. 3. The tweet displays the title of “Why You Should
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`Not Use Ivermectin to Treat or Prevent COVID-19” and includes a link to that
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`publication. Id.
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`
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`d. An April 26, 2022 tweet that reads: “Hold your horses, y’all. Ivermectin may be
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`trending, but it still isn’t authorized or approved to treat COVID-19.” Ex. 4. The
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`tweet again displays the title of “Why You Should Not Use Ivermectin to Treat or
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`Prevent COVID-19” and includes a link to that publication. Id.
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`3
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`5.
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`The FDA proceeded with knowledge and intent that these actions would interfere
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`with the practice of medicine.
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`6.
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`The FDA acted in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”)
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`and the Administrative Procedure Act (“APA”).
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`7.
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`Because the FDA has unlawfully attempted to prohibit the use of ivermectin to treat
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`COVID-19, or to otherwise interfere with the practice of medicine, this Court should hold unlawful
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`and set aside any FDA actions that direct or opine on whether ivermectin is an appropriate
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`treatment for COVID-19, declare such actions unlawful, and issue permanent injunctive relief
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`enjoining the FDA from further engaging in such actions.
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`8.
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`This is not the first pandemic our country has faced, nor will it be the last. And
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`COVID-19 isn’t going away. If the FDA is not limited to its statutory lane, its unlawful actions
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`will no doubt persist and repeat themselves.
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`9.
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`Moreover, if the FDA is allowed to interfere with the practice of medicine now
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`under cover of a pandemic, this interference will metastasize to other circumstances, destroying
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`the carefully constructed statutory wall between federal and state regulatory powers, and between
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`the FDA and the professional judgment of health professionals.
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`PARTIES
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`10.
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`Plaintiffs are doctors who have been harmed by the FDA’s interference with the
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`practice of medicine.
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`Robert L. Apter, M.D., FACEP
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`11.
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`Robert L. Apter, M.D., graduated from the University of Colorado School of
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`Medicine in 1974. Ex. 5, Declaration of Robert L. Apter, M.D., FACEP, at 1. He has over 40 years
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`of experience in emergency medicine. Id.
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`4
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`12.
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`Dr. Apter is licensed to practice medicine in Arizona and Washington. Id. He is a
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`certified Diplomate of the American Board of Emergency Medicine and a Fellow of the American
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`College of Emergency Physicians. Id.
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`13.
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`Dr. Apter has completed over 6,000 patient consultations for COVID-19 through
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`MyFreeDoctor.com, about half for prophylaxis and half for treatment, with a patient survival rate
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`over 99.98%. Id. He has frequently prescribed ivermectin to these patients, finding the treatment
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`effective. Id.
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`14.
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`Dr. Apter asserts that statements by the FDA to stop using ivermectin to treat
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`COVID-19 have interfered with his ability to exercise professional medical judgment in practicing
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`medicine. Id. The off-label prescription of drugs is common and well-established medical practice,
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`and often necessary for the effective treatment of each unique patient. Id.
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`15.
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`Pharmacists have refused to fill ivermectin prescriptions for Dr. Apter’s patients,
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`citing the FDA’s statements on using the drug to treat COVID-19. Id. This refusal delays his
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`patients in obtaining their prescribed treatment—when early intervention is paramount—while
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`they look for a pharmacy to fill their prescription, if they can find one at all. Id.
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`16.
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`In Dr. Apter’s professional experience, the practice of medicine is affected by FDA
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`statements regardless of whether the FDA can legally enforce them, because the practice of
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`medicine has become highly driven by standards and guidelines. Id. at 1–2. Doctors are
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`increasingly employees of entities that look to the FDA for guidance and enforce standards
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`accordingly. Id. Government pressure, largely through the FDA, has also led pharmacies—
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`especially in large corporate chains—to refuse to fill ivermectin prescriptions for COVID-19,
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`because that position is supported by the FDA. Id.
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`5
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`17.
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`Dr. Apter has observed that patients believe that FDA’s pronouncements are
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`authoritative and want care that complies with such pronouncements. Id. at 3. Further, insurance
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`companies are refusing to pay for ivermectin to treat COVID-19, and the only observable basis for
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`this is pronouncements and pressure from the FDA. Id.
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`18.
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`Dr. Apter has been referred to the Washington Medical Commission and Arizona
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`Medical Board for disciplinary proceedings for prescribing ivermectin to treat COVID-19. Id. The
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`referrals include copies of the FDA’s publications directing against the use of ivermectin to treat
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`COVID-19. Id. He explains that state regulatory boards rely heavily on pronouncements from the
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`FDA. Id. at 3.
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`Mary Talley Bowden, M.D.
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`19.
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`Plaintiff Mary Talley Bowden, M.D., graduated summa cum laude from the
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`Medical College of Georgia in 1998. Ex. 6, Declaration of Mary Talley Bowden, M.D., at 1. She
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`completed residency in Otolaryngology–Head and Neck Surgery at the Stanford University
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`Medical Center in 2003. Id. She is certified by the American Board of Otolaryngology, and for
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`Sleep Medicine by the American Board of Internal Medicine. Id.
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`20.
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`21.
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`Dr. Bowden is licensed to practice medicine in Texas. Id.
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`Dr. Bowden began recommending ivermectin to treat COVID-19 in early 2020 and
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`found the therapy effective. Id. She was derided by Houston Methodist Hospital and forced to
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`resign her privileges there as a result. Id.
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`22.
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`Dr. Bowden is the owner of BreatheMD, where she continues to treat COVID-19
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`patients. Id. She is also a clinical advisor at the Front Line COVID-19 Critical Care Alliance. Id.
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`23.
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`Dr. Bowden has treated more than 3,900 patients for COVID-19, with a success
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`rate over 99.97%. Id. No patient who received early treatment from her required hospitalization.
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`6
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`Id. The only patient who did not recover was already in the late stages of the disease and needed
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`ventilator support before seeing Dr. Bowden. Id.
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`24.
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`The FDA’s actions regarding ivermectin, specifically its directives to stop using the
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`drug to treat COVID-19, have harmed Dr. Bowden’s ability to practice medicine and treat patients.
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`Id. As her attached declaration observes, health professionals, regulatory boards, and patients feel
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`compelled to follow any directives or recommendations from the FDA, which presents itself as
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`the authoritative source on the appropriate use of drugs. Id. This is especially true during a
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`pandemic. Id.
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`25.
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`Dr. Bowden also explains that the off-label prescription of drugs is common and
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`well-established medical practice. Id. at 2. Doctors must be able to exercise their professional
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`medical judgment in the context of each specific patient, including by prescribing drugs off-label,
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`to effectively practice medicine. Id. But by inserting itself into the practice of medicine, the FDA
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`has intentionally manipulated the ability of doctors to use ivermectin—a famously safe drug—off-
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`label. Id.
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`26.
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`Other doctors have referred patients to Dr. Bowden specifically because she
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`prescribes ivermectin to treat COVID-19. Id.
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`27.
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`Pharmacists have refused to fill ivermectin prescriptions for Dr. Bowden’s patients,
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`citing FDA directives not to use the drug to treat COVID-19, thereby interfering with her ability
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`to treat patients in a timely manner. Id.
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`28.
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`Pharmacists have likewise refused to fill ivermectin prescriptions for Dr. Bowden’s
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`patients because it is not FDA approved for the treatment of COVID-19, treating those off-label
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`prescriptions in a manner categorically different from other off-label prescriptions. Id.
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`7
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`29.
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`Patients have also delayed seeking treatment from Dr. Bowden because the FDA
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`says not to use ivermectin to treat COVID-19, only to reverse course when other treatments don’t
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`work. Another patient similarly delayed following a course of treatment using ivermectin as
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`recommended by Dr. Bowden—even after filling that prescription—because of the FDA, again
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`only to reverse course when other treatment didn’t work. Id. These delays can be devastating
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`because early treatment of COVID-19 is key. Id.
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`Paul E. Marik, MBBCh, M.Med, FCCM, FCCP
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`30.
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`Plaintiff Paul E. Marik, MBBCh, M.Med, FCCM, FCCP, is a critical care specialist
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`who has practiced medicine for over 40 years. Ex. 7, Declaration of Paul E. Marik, MBBCh,
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`M.Med, FCCM, FCCP, at 1.
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`31.
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`Dr. Marik received his medical degree in 1981 from the University of
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`Witwatersrand in Johannesburg, South Africa. Id. His academic credentials include:
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` Bachelor of Medicine and Surgery (MBBCh), from the University of
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`Witwatersrand;
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` Bachelor of Science with Honors in Pharmacology, from the University of
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`Witwatersrand;
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` Master of Medicine, from the University of Witwatersrand;
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` Diploma in Tropical Medicine and Hygiene (DTM&H), from the University
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`of Witwatersrand.
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`Id.
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`32.
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`Dr. Marik is a Fellow of the College of Physicians of South Africa, a Fellow of The
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`Royal College of Physicians of Canada, a Fellow of the American College of Critical Care
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`Medicine, and a Fellow of the American College of Chest Physicians. Id.
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`8
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`33.
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`Dr. Marik is certified by the:
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` American Board of Internal Medicine, for Internal Medicine and Critical
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`Care Medicine;
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` American Board of Physician Nutrition Specialists, as a Physician Nutrition
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`Specialist;
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` United Council for Neurological Subspecialities (USA), as a Neurocritical
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`Care Specialist;
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` British Medical Council, as a General Practitioner with a specialty
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`certification in Internal Medicine;
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` South African Medical and Dental Council, as a General Practitioner with
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`a specialty certification in Internal Medicine, and a sub-specialty
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`certification in Critical Care Medicine; and
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` Canadian Medical Council, as a General Practitioner with a specialty
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`certification in Internal Medicine, and a sub-specialty certification in
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`Critical Care Medicine.
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`Id. at 1–2.
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`34.
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`According to Semantic Scholar, Dr. Marik has over 750 publications and been cited
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`more than 40,000 times, with an h-index of 95. Id. at 2; P. Marik, Semantic Scholar,
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`https://www.semanticscholar.org/author/P.-Marik/3887524 (last accessed June 1, 2022).
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`35.
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`Dr. Marik is among the top scientists across all scientific fields according to John
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`P. A. Ioannidis et al., A Standardized Citation Metrics Author Database Annotated for Scientific
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`Field, PLoS Biol. 17(8), table S1 (2019), https://doi.org/10.1371/journal.pbio.3000384.
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`9
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`36.
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`Expertscape’s PubMed-based algorithm ranks Dr. Marik in the top .01% of scholars
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`worldwide on sepsis, a life-threatening condition and common result of COVID-19. Ex. 7, at 2;
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`Expertise in Sepsis: Paul Ellis Marik, Expertscape, https://www.expertscape.com/au/sepsis/
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`Marik%2C+P (last accessed June 1, 2022).
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`37.
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`Dr. Marik is a founding member and Co-Chief Medical Officer at the Front Line
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`COVID-19 Critical Care Alliance. Ex. 7, at 2.
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`38.
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`Dr. Marik was a Professor of Medicine and Chief of Pulmonary and Critical Care
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`Medicine at Eastern Virginia Medical School (“EVMS”) in Norfolk, Virginia, from 2009 through
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`2021, with tenure starting in 2014. Id. He also served as a Director of the Intensive Care Unit at
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`Sentara Norfolk General Hospital. Id.
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`39.
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`Dr. Marik developed a protocol for EVMS for treating COVID-19. Id. It was called
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`the EVMS COVID-19 Management Protocol, which included the MATH+ Protocol. Id.
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`Ivermectin was added to the EVMS COVID-19 Management Protocol, including the MATH+
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`Protocol, after Dr. Marik and others observed that the drug was effective to treat COVID-19,
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`especially as an early treatment. Id.; see, e.g., Ex. 8, EVMS COVID-19 Management Protocol
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`(Dec. 17, 2020), at 6–7, 9–10, 13, 18.
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`40.
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`Dr. Marik was directed by EVMS to remove the protocol from its servers and not
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`speak publicly about ivermectin following the FDA’s August 21, 2021 tweet deriding the drug as
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`animal medication and directing against its use to treat COVID-19. Ex. 7, at 2.
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`41.
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`Sentara also issued a “Call for Immediate End to Prescribing, Dispensing, and Use
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`of Ivermectin to Prevent or Treat COVID-19 Outside Clinical Trials” to its hospitals, citing in part
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`the FDA. Ex. 9, Sentara Comprehensive COVID-19 Treatment Guidelines—Version 26 (Sept. 27,
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`2021), at 3.
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`10
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`42.
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`The FDA’s actions harmed Dr. Marik’s ability to practice medicine. Id. at 2–3. He
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`was forced to resign from his positions at EVMS and Sentara Norfolk General Hospital for
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`promoting the use of ivermectin—as well as other safe, cheap, and effective off-label FDA-
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`approved drugs—to treat COVID-19 following the FDA’s attempts to stop use of those drugs for
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`that purpose. Id.
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`43.
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`Dr. Marik explains that it doesn’t matter whether FDA statements are technically
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`binding on health professionals. In his experience and observation, after the FDA’s decision to
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`interfere with the use of ivermectin to treat COVID-19, doctors have been threatened with
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`revocation of their medical licenses and adverse disciplinary actions should they prescribe the drug
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`contrary to the FDA’s public position. Hospitals have relied on FDA publications to prohibit their
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`pharmacies from dispensing ivermectin and have threatened doctors with revocation of their
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`privileges if they don’t comply with NIH/FDA guidelines. Many pharmacists have refused to fill
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`prescriptions for out-patients with COVID-19 because the drug is not “FDA approved” for this
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`purpose, even though filling off-label prescriptions is routine. Refusing to allow patients to receive
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`effective early treatment for COVID-19 has led to innumerable hospitalizations and deaths, and
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`caused extreme distress for patients, their families, and health professionals. Id. at 3.
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`Defendants
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`44.
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`Defendants are United States governmental agencies and appointed officials of the
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`United States government responsible for the challenged actions. The individual named defendants
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`are all sued in their official capacities.
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`45.
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`Defendant Xavier Becerra, in his official capacity as Secretary of Health and
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`Human Services, has authority over the U.S. Department of Health and Human Services (“HHS”)
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`and its components, including the FDA.
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`46.
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`Defendant Robert M. Califf, M.D., MACC, in his official capacity as Acting
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`Commissioner of Food and Drugs, has authority over the FDA and the unlawful actions of that
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`agency to prohibit or otherwise interfere with the use of ivermectin to treat COVID-19.
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`JURISDICTION AND VENUE
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`47.
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`This Court has jurisdiction under 5 U.S.C. §§ 701–706, and 28 U.S.C. §§ 1331,
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`1346, 1361, 2201, under the U.S. Constitution, and pursuant to the equitable powers of this Court.
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`48.
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`The Court is authorized to award the requested relief under 5 U.S.C. §§ 702, 706,
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`and 28 U.S.C. §§ 1361, 2201, 2202, and pursuant to the equitable powers of this Court.
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`49.
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`Venue is proper under 28 U.S.C. § 1391(e)(1)(B) because an officer of the United
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`States in his or her official capacity, or an agency of the United States, is a Defendant, and a
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`substantial part of the events giving rise to Plaintiffs’ claims occurred in this District. Venue is
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`also proper under 28 U.S.C. § 1391(e)(1)(C) because an officer of the United States in his or her
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`official capacity, or an agency of the United States, is a Defendant, and Dr. Bowden resides in this
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`District, and no real property is involved.
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`FACTUAL BACKGROUND
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`The FDA
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`50.
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`The FDCA establishes the FDA as an agency within HHS. 21 U.S.C. § 393. The
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`Secretary of Health and Human Services is responsible for executing the FDCA through the
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`Commissioner of Food and Drugs. Id. § 393(d).
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`51.
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`The FDA has authority under the FDCA to approve a drug “for introduction into
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`interstate commerce” if the agency determines it is “safe for use under the conditions prescribed,
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`recommended, or suggested in the proposed labeling thereof,” and there is “substantial evidence
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`that the drug will have the effect it purports or is represented to have under the conditions of use
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`12
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`prescribed, recommended, or suggested in the proposed labeling thereof.” Id. § 355(d); see 21
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`C.F.R. § 201.57.
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`52.
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`The FDA can also collect information on adverse events resulting from use of
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`approved drugs, 21 U.S.C. § 355(k), request changes to drug labeling, id. § 355(o)(4), impose risk
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`evaluation and mitigation strategies like mandatory patient monitoring, id. § 355-1, communicate
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`the risks of using approved drugs, id. § 360bbb-6, and even withdraw approval of a drug entirely
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`under certain circumstances, id. § 355(e).
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`53.
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`None of these provisions authorize the FDA to prohibit, direct, or advise against
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`off-label uses of drugs approved for human use.
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`54. When Congress has authorized the FDA to limit particular uses of an approved
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`drug, it has done so explicitly. E.g., id. § 333(e).
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`55.
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`The FDA also has authority to regulate animal drugs, id. §§ 321(g)(1), 351(a)(1),
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`360(b), which includes the ability to “prohibit particular uses of an animal drug.” Id.
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`§ 360b(a)(4)(A). No similar authority exists for the FDA to prohibit particular uses of human
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`drugs.
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`56.
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`Importantly, the FDCA further provides in 21 U.S.C. § 396 that nothing in the
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`statute “shall be construed to limit or interfere with the authority of a health care practitioner to
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`prescribe or administer any legally marketed device for any condition or disease within a legitimate
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`health care practitioner-patient relationship.”
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`57.
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`Courts have consistently cited § 396 as applying to the prescription or
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`administration of drugs as well. See Markland v. Insys Therapeutics, Inc., 758 F. App’x 777, 780
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`(11th Cir. 2018); U.S. ex rel King v. Solvay Pharms., Inc., 871 F.3d 318, 328 (5th Cir. 2017); U.S.
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`ex rel. Nathan v. Takeda Pharms. N. Am., Inc., 707 F.3d 451, 454 n.2 (4th Cir. 2013); United States
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`13
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`v. Caronia, 703 F.3d 149, 167 (2d Cir. 2012); United States v. Muoghalu, 662 F.3d 908, 911 (7th
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`Cir. 2011); Smith v. C.R. Bard, Inc., 730 F. Supp. 2d 783, 803 (M.D. Tenn. 2010).
`
`58.
`
`The FDA thus cannot interfere with “the practice of medicine, which is the
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`exclusive realm of individual states.” Planned Parenthood Cincinnati Region v. Taft, 444 F.3d
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`502, 505 (6th Cir. 2006); see Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001)
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`(“[T]he FDA is charged with the difficult task of regulating the marketing and distribution of
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`medical devices without intruding upon decisions statutorily committed to the discretion of health
`
`care professionals.”); Ass’n of Am. Physicians & Surgeons v. FDA, 13 F.4th 531, 534 (6th Cir.
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`2021) (“Although the [FDCA] regulates a manufacturer’s distribution of drugs, it does not go
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`further by regulating a doctor’s practice of medicine. . . . It instead leaves the regulation of doctors
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`to the states.”); see also Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390, 400 (D.C. Cir.
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`2021) (“Choosing what treatments are or are not appropriate for a particular condition is at the
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`heart of the practice of medicine.”).
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`59.
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`As a result, once a drug has been approved by the FDA for human use, appropriate
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`health professionals can prescribe or dispense the drug off-label when done for a medical purpose
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`within the scope of a doctor-patient relationship. See Buckman Co., 531 U.S. at 350 (“‘[O]ff-label’
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`usage of medical devices (use of a device for some other purpose than that for which it has been
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`approved by the FDA) is an accepted and necessary corollary of the FDA’s mission to regulate in
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`this area without directly interfering with the practice of medicine.”); Judge Rotenberg Educ. Ctr.,
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`Inc., 3 F.4th at 395 (“Section 396 ensures that once the FDA permits a device to be marketed for
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`one use, health care practitioners have the flexibility to draw on their expertise to prescribe or
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`administer the device for any condition or disease, not just the use the FDA approved—in short,
`
`to practice medicine.”); Solvay Pharms., Inc., 871 F.3d at 328 (“[T]he FDA does not restrict
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`Case 3:22-cv-00184 Document 1 Filed on 06/02/22 in TXSD Page 15 of 37
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`physicians from prescribing an otherwise FDA-approved drug for an off-label use.”); In re
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`Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 240 (3d Cir. 2012)
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`(“Because the FDCA does not regulate the practice of medicine, physicians may lawfully prescribe
`
`drugs for off-label uses.”); Planned Parenthood Cincinnati Region, 444 F.3d at 505 (“Absent state
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`regulation, once a drug has been approved by FDA, doctors may prescribe it for indications and in
`
`dosages other than those expressly approved by the FDA. . . . Off-label use does not violate federal
`
`law or FDA regulations[.]”); Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir.
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`2000) (“A physician may prescribe a legal drug to serve any purpose that he or she deems
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`appropriate, regardless of whether the drug has been approved for that use by the FDA.”);
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`Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine
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`and Hydroxychloroquine, FDA (June 15, 2020), https://www.fda.gov/news-events/press-
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`announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-
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`chloroquine-and (“FDA approved products may be prescribed by physicians for off-label uses if
`
`they determine it is appropriate for treating their patients, including during COVID.”).
`
`60.
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`FDA regulations recognize that the agency cannot interfere with the practice of
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`medicine or off-label use of approved drugs. 21 C.F.R. § 312.2(d) (“This part does not apply to
`
`the use in the practice of medicine for an unlabeled indication of a new drug product approved
`
`under part 314 or of a licensed biological product.”).
`
`61.
`
`Appropriate healthcare professionals can—and often do—prescribe or dispense
`
`drugs off-label precisely because they have been approved by the FDA for human use. Christopher
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`M. Wittich et al., Ten Common Questions (and Their Answers) About Off-label Drug Use, 87
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`Mayo Clinic Proc. 982 (2012), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/. Off-
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`label prescriptions are “common, and can be a source of innovation, and in some settings may
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`Case 3:22-cv-00184 Document 1 Filed on 06/02/22 in TXSD Page 16 of 37
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`represent the standard of care.” Donna T. Chen et al., U.S. Physician Knowledge of the FDA-
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`Approved Indications and Evidence Base for Commonly Prescribed Drugs: Results of a National
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`Survey, 18 Pharmacoepidemiology & Drug Safety 1094, 1094 (2009) (footnotes omitted).
`
`62.
`
`One study found that 21% of all prescriptions were for off-label use. Wittich et al.,
`
`supra. That fraction is nearly twice as high, 36.2%, in intensive care units. Id.
`
`63.
`
`The National Ambulatory Medical Care Survey observed that 38.3% of
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`prescriptions are for off-label uses. W. David Bradford et al., Off-Label Use of Pharmaceuticals:
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`A Detection Controlled Estimation Approach, 66 J. Indus. Econ. 866, 866 (2019).
`
`64.
`
`Regarding off-label prescriptions, the FDA has acknowledged that “[g]ood medical
`
`practice and the best interests of the patient require that physicians use legally available drugs,
`
`biologics and devices according to their best knowledge and judgment.” “Off- Label” and
`
`Investigational Use of Marketed Drugs, Biologics, and Medical Devices, FDA (May 6, 2020),
`
`https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-
`
`investigational-use-marketed-drugs-biologics-and-medical-devices.
`
`65.
`
`An FDA Deputy Commissioner for External Affairs likewise emphasized that “off-
`
`label drug use is often essential to good medical practice,” and “it is on this edge that science and
`
`medicine move forward to benefit patients with intractable illness.” Carol Scheman, Prescription
`
`Drug Marketing and Promotion—An FDA Perspective, Address before the PMA Public Affairs
`
`Section, Mid-Year Meeting (Apr. 15, 1992).
`
`66.
`
`The Council on Scientific Affairs of the American Medical Association (“AMA”)
`
`agrees, reporting that “[t]he prevalence and clinical importance of prescribing drugs for unlabeled
`
`uses are substantial,” and “the prescribing of FDA-approved drugs for unlabeled uses is often
`
`necessary for optimal patient care.” Joseph W. Cranston, et al., Report of the Council on Scientific
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`Case 3:22-cv-00184 Document 1 Filed on 06/02/22 in TXSD Page 17 of 37
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`Affairs: Unlabeled Indications of Food and Drug Administration-Approved Drugs, 32 Drug Info.
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`J., 1049, 1050–51 (1998).
`
`The COVID-19 Pandemic
`
`67.
`
`On January 31, 2020, the Secretary of Health and Human Services determined that
`
`COVID-19 resulted in a public health emergency under section 319 of the Public Health Service
`
`Act, Pub. L. No. 78–410, as amended.
`
`68.
`
`On March 13, 2020, President Trump determined pursuant to the National
`
`Emergencies Act, 50 U.S.C. § 1601 et seq., that the COVID–19 outbreak in the United States
`
`constituted a national emergency that threatened national security.
`
`69.
`
`The United States has suffered 1,004,447 deaths attributed to COVID-19 as of the
`
`week ending on May 28, 2022. See COVID-19 Mortality Overview, CDC, https://www.cdc.gov/
`
`nchs/covid19/mortality-overview.htm (last accessed June 1, 2022).
`
`Ivermectin
`
`70.
`
`Ivermectin was developed in the late 1970s and has been used successfully for over
`
`forty years to treat humans for onchocerciasis (commonly known as river blindness), worm
`
`infections, scabies, and other parasitic diseases.
`
`71.
`
`The World Health Organization lists ivermectin as an “essential medicine.” Ex. 10,
`
`World Health Organization Model List of Essential Medicines 6, 24 (22nd ed. 2021),
`
`https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02.
`
`72.
`
`Alongside penicillin and aspirin, ivermectin is one of the “few drugs that can
`
`seriously lay claim to the title of ‘Wonder drug’ . . . . based on its versatility, safety and the
`
`beneficial impact that it has had, and continues to have, worldwide—especially on hundreds of
`
`millions of the world’s poorest people.” Andy Crump & Satoshi Ōmura, Ivermectin, ‘Wonder
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`Drug’ from Japan: The Human Use Perspective, 87 Proc. Jpn. Acad., Ser. B 13, 13 (2011),
`
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740/pdf/pjab-87-013.pdf.
`
`73.
`
`Sculptures have been erected around the world—from Atlanta to Amsterdam, from
`
`the World Bank to the World Health Organization itself—to commemorate the accomplishments
`
`of ivermectin. Derek Yach, Health as a Cornerstone of Good Business and Sustainable
`
`Development, 106 Am. J. Pub. Health 1758, 1759 (2016), https://www.ncbi.nlm.nih.gov/pmc/
`
`articles/PMC5024391/pdf/AJPH.2016.303387.pdf.
`
`74.
`
`In 1996, the FDA approved ivermectin for use in humans to treat onchocerciasis
`
`and a parasitic roundworm, strongyloidiasis. Ex. 11, Center for Drug Evaluation and Research,
`
`Approval Package for: Ivermectin (1996), https://www.accessdata.fda.gov/drugsatfda_docs/nda/
`
`96/050742ap.pdf.
`
`75.
`
`The FDA has also approved ivermectin for use in animals. See, e.g., ZIMECTERIN
`
`GOLD—Ivermectin and Praziquantel Paste, FDA (Jan. 4, 2021), https://www.accessdata.fda.gov/
`
`spl/data/3553c950-dd70-413e-8d58-ee8d792bbbe3/3553c950-dd70-413e-8d58-ee8d792
`
`bbbe3.xml.
`
`76.
`
`Ivermectin is a very safe drug. It “has been used safely in 3.7 billion doses
`
`worldwide since 1987 and is well tolerated even at much greater doses than the standard single
`
`dose of 200 μg/kg.” Alessandro D. Santin et al., Ivermectin: A Multifaceted Drug of Nobel Prize-
`
`Honoured Distinction with Indicated Efficacy Against a New Global Scourge, COVID-19, New
`
`Microbes & New Infections 43:100924, at 2 (2021), https://www.ncbi.nlm.nih.gov/pmc/articles/
`
`PMC8383101/. In fact, Merk has now donated over 4.4 billion treatments of ivermectin, brand
`
`name Mectizan, for use in mass distribution campaigns alone. See 35 Years: The Mectizan
`
`Donation Program, Merck (May 25, 2022), https://www.merck.com/stories/mectizan/ (“The
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`Case 3:22-cv-00184 Document 1 Filed on 06/02/22 in TXSD Page 19 of 37
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`program reaches more than 300 million people in the affected areas annually, with more than 4.4
`
`billion treatments donated since 1987.”).
`
`77.
`
`A 2002 study demonstrated that ivermectin is safe even at dosages many multiples
`
`higher than the treatment initially approved by the FDA. See Cynthia A. Guzzo, MD, et al., Safety,
`
`Tolerability, and Pharmacokinetics of Escalating High Doses of Ivermectin in Healthy Adu