White House ignored FDA, ordered hydroxychloroquine to be sent to pharmacies, investigation finds

The White House ordered the strategic national stockpile to distribute millions of hydroxychloroquine pills to retail pharmacies despite FDA regulations that they only be given to hospitals and clinical trial sponsors, The Washington Post reported. 

According to documents obtained by the Post through a Freedom of Information Act request, in April the White House ordered distribution of 23 million hydroxychloroquine pills from the national stockpile to a dozen states. The White House ordered the tablets to be delivered to retail pharmacies in five cities, the documents state.

Hydroxychloroquine is approved for use to treat lupus, rheumatoid arthritis and malaria. In March, the FDA granted emergency use authorization of the drug for hospitalized COVID-19 patients and those in clinical trials. But in June, the agency revoked the authorization after finding hundreds of adverse events linked to the drug in COVID-19 patients, including dozens of deaths, according to the Post

Three distributors, AmerisourceBergen, Cardinal Health and McKesson, told the Post they didn’t ship hydroxychloroquine to retail pharmacies despite the administration’s request. Cardinal Health said it sent the drug to long-term care facilities and hospitals. 

“At the direction of the White House, [the strategic national stockpile] did a one-time shipment of hydroxychloroquine to several commercial distributors to support further distribution of hydroxychloroquine directly to hospitals and retail pharmacies in the hard-hit areas of NYC, Detroit, Chicago and New Orleans,” a senior analyst at HHS said in an internal email exchange, the Post reported. 

HHS confirmed to the Post that the hydroxychloroquine pills were supposed to go to retail pharmacies, but it said that the department doesn’t know where the pills ended up. HHS told the Post  the drugs were intended to be used for lupus patients. 

CVS and Walgreens told the Post they didn’t receive or distribute shipments of hydroxychloroquine. Rite Aid didn’t respond to the Post’s requests for comment. 

Assistant Secretary for Health Brett Giroir, MD, said in an email in April that off-label use of hydroxychloroquine was appropriate for COVID-19 patients, the Post reported. 

“NOPE,” Dr. Giroir wrote. “Needs to go to pharmacies as well. The EUA matters not — The drug is approved any [sic] therefore can be prescribed as per doctor’s orders That is a FINAL ANSWER.” 

Giroir said that pharmacies needed the drug for lupus and rheumatoid arthritis patients, according to the Post

Read the full article here.

More articles on pharmacy:
Ascension launches pharmacy services business Ascension Rx
6 recent pharma industry exec moves
FDA lists essential medicines, countermeasures and pharmaceutical ingredients


© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.