Doctors Sue FDA, HHS Over Hydroxychloroquine Restrictions

The Association of American Physicians and Surgeons (AAPS) has filed a lawsuit against the heads of the FDA, HHS and the Biomedical Advanced Research and Development Authority (BARDA) over what they call “irrational interference” to limit the use of hydroxychloroquine (HCQ) for treating COVID-19 patients.

In its complaint filed in U.S. District Court in the western district of Michigan, AAPS criticized the FDA’s Emergency Use Authorization (EUA) for the antimalaria drug that limits its use to hospitalized COVID-19 patients who can’t participate in trials. They said the restriction lacks any legal or factual justification and was influenced by a politically biased official. They seek release of the drug without restrictions.

The association claimed that Rick Bright, the former head of BARDA and a government whistleblower who has publicly criticized President Trump, “distorted the agency process to arbitrarily and unjustifiably limit access by patients to hydroxychloroquine received as donations by the federal government” for distribution to the public.

“These arbitrary, irrational and unjustifiable limitations by the FDA in its EUA prevents the use of HCQ as a prophylaxis in nursing homes and when in the best interests of nonhospitalized patients,” the association said. It is seeking declaratory and injunctive relief from the agencies it is suing.

The doctors allege that, while FDA Commissioner Stephen Hahn claims the agency does not involve itself in physicians’ abilities to prescribe the medicine, it is currently blocking access to the 150 million-dose supply donated to the national stockpile.

“This irrational hoarding by government is an abuse of power,” the group says, claiming that most of the doses have not been distributed and are approaching spoilage as higher summer temperatures draw near.

The doctors note that other countries, including China, Costa Rica, India, South Korea, Turkey and the United Arab Emirates, are using the drug for early treatment and prevention of COVID-19.

Recent trials have shown hydroxychloroquine to be ineffective as a COVID-19 treatment, but a recent scandal has raised questions about the supporting data. Last week, The Lancet retracted findings from a large, 96,032-patient study of hydroxychloroquine and chloroquine after an inquiry into its data. The study’s findings suggested that the drug increased the risk of death in COVID-19 patients. But the authors admitted that their data could not be trusted after the data analytics company they used, Surgisphere, refused to provide its full data set (DID, June 5).

Most recently, the chief investigators of the RECOVERY trial, a University of Oxford study of multiple potential treatments for COVID-19, “concluded that there is no beneficial effect of hydroxychloroquine” in hospitalized COVID-19 patients. In response to the findings, they have ended enrollment to their hydroxychloroquine trial.

Read the AAPS complaint here: www.fdanews.com/06-05-20-Court.pdf. — James Miessler