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Physicians Sue FDA to Widen Access to Hydroxychloroquine (1)

June 3, 2020, 4:52 PMUpdated: June 3, 2020, 7:27 PM

The Association of American Physicians and Surgeons wants the Food and Drug Administration to stop limiting access to national stores of hydroxychloroquine, a drug championed by President Donald J. Trump as a means of preventing Covid-19.

The conservative nonprofit group sued FDA in the U.S. District Court for the Western District of Michigan Tuesday, alleging the agency is “irrationally” interfering with doctors’ and patients’ access to the Strategic National Stockpile’s cache of the antimalarial drug.

FDA officials left over from President Barack Obama’s administration acted arbitrarily, unlawfully, and contrary to Trump’s wishes when they approved access to the drug only for adults and adolescents hospitalized with Covid-19 who aren’t able to participate in clinical trials studying the drug’s use as a treatment for the disease.

Officials should have made the drug widely available for prophylactic or preventative uses, the complaint says.

The officials included Rick Bright, according to the complaint. Bright has filed a whistleblower complaint claiming the administration pushed him out of his job as head of the Biomedical Advanced Research and Development Authority because he criticized its response to the coronavirus pandemic.

FDA has approved hydroxychloroquine for treating malaria, lupus, and rheumatoid arthritis. In March, it issued an emergency use authorization that allows health-care providers to use hydroxychloroquine from the Strategic National Stockpile within certain limitations.

In April, FDA issued a drug safety communication warning that hydroxychloroquine shouldn’t be used outside of clinical trials as a treatment for Covid-19. The agency said it was aware of reports of serious heart problems in Covid-19 patients. It also said the drug hasn’t been proven to be effective for this use.

AAPS describes itself as an organization dedicated to “preserving the sanctity of the patient-physician relationship and the practice of private medicine.” It opposes the Affordable Care Act, Medicare, and most government interference with health care.

Causes of Action: Equal protection, administrative procedure act, First Amendment.

Relief: Declaratory judgment that restrictions are invalid; block FDA from restricting access to hydroxychloroquine and require agency to make it widely available to people holding valid prescriptions; costs and attorneys’ fees.

Response: The FDA doesn’t comment on pending litigation, an agency spokesman told Bloomberg Law.

Attorneys: AAPS’s general counsel’s office and Law Office of Lawrence J. Joseph of Washington represent AAPS.

The case is Ass’n of Am. Physicians & Surgeons v. Food & Drug Admin., W.D. Mich., No. 20-cv-493, filed 6/2/20.

(Updated to clarify that complaint seeks access to federal government stores of drug, and to add FDA's response.)

To contact the reporter on this story: Mary Anne Pazanowski in Washington at mpazanowski@bloomberglaw.com

To contact the editors responsible for this story: Rob Tricchinelli at rtricchinelli@bloomberglaw.com; Nicholas Datlowe at ndatlowe@bloomberglaw.com

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