Back in March, drug giant Novartis donated 130 million doses of the anti-malaria drug hydroxychloroquine to the global Wuhan coronavirus (COVID-19) pandemic response. But the U.S. Food and Drug Administration (FDA) has been directly interfering with its distribution, which has prompted a new lawsuit.
The American Association of Surgeons and Physicians (AASP) has filed a complaint for declaratory and injunctive relief against the Department of Health & Human Services (HHS), along with the FDA and the Biomedical Advanced Research & Development Authority, two of its constituent agencies. Also named in the suit are the “lead officers” of these agencies.
According to the AASP, the FDA has been engaged in “irrational interference” concerning patients having “timely access” to hydroxychloroquine. Despite the fact that large amounts of hydroxychloroquine were donated to the federal government for “prompt distribution,” the FDA has seen to it that very few of these drug doses make it out to patients.
On March 28, just days after Novartis donated large quantities of hydroxychloroquine to the federal government, the FDA issued an “Emergency Use Authorization” that essentially prohibited the drug from being administered except in the case of “already-hospitalized patients for whom clinical trials are unavailable.”
“Through a biased, unlawful process described in greater detail below,” the suit states, “FDA officials from prior administrations acted contrary to the wishes of President Donald Trump, by arbitrarily limiting use of HCQ from the Strategic National Stockpile (SNS) to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible.”….