Trump touted the pills to treat covid-19.

White House sidestepped FDA to distribute hydroxychloroquine to pharmacies, documents show. Trump touted the pills to treat covid-19.

For days Trump had touted the off-label use of the anti-malarial drug hydroxychloroquine as a potential cure for covid-19, despite a lack of scientific evidence it worked and amid mounting concerns about the dangers to patients with underlying medical conditions.

Trump trade adviser Peter Navarro wanted to make sure the administration’s top vaccine expert would be on board with a White House plan to distribute the unproven drug to hard-hit cities.

“The first thing out of his mouth was, ‘I want to know what team you are on,’ ” recalled Rick Bright, who at the time was responsible for stockpiling drugs for medical emergencies as director of the federal Biomedical Advanced Research and Development Authority.

The immunologist, who later filed a whistleblower complaint against the administration, said in an interview with The Washington Post that he told Navarro he was on the side of medical evidence. Navarro, Bright said, replied, “I won’t hold it against you, but we need to move this forward.” Navarro declined to comment on Bright’s account.

The White House decision to set aside the mandatory safety controls put in place by the Food and Drug Administration fueled one of the most disputed initiatives in the administration’s response to the pandemic: the distribution of millions of ineffective, potentially dangerous pills from a federally controlled cache of drugs called the Strategic National Stockpile.

Over a span of four days in early April, the White House ordered the distribution of 23 million hydroxychloroquine tablets from the stockpile to a dozen states, enough pills for 1.4 million covid-19 patients, according to public records obtained by The Post in response to a Freedom of Information Act request.

The Post review found that the process was marked by haphazard planning, little or no communication to local authorities about the flow of pills into their communities, and a lack of public accounting about where they ended up.

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The documents also demonstrate the steps the administration took to bypass the FDA’s March 28 authorization for emergency use of the tablets, which limited their use to hospitals and clinical drug trials. According to FDA guidance at the time, state authorities were supposed to request stockpile supplies before they were delivered. But interviews and documents show that procedure was not followed in many cases.

The White House ordered more than a third of the tablets sent to the three major drug distributors in the United States with instructions to deliver them not only to hospitals but also retail pharmacies in five U.S. cities, despite the FDA controls, according to public records.

At the direction of the White House, SNS 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.

One major wholesaler said it shipped to long-term care facilities, which also were not covered in the FDA’s emergency authorization. All three distributors told The Post they did not ship to retail pharmacies, despite the administration’s request.

The Department of Health and Human Services, which oversees the stockpile, confirmed in an email to The Post that the pills were supposed to go to retail pharmacies but that the agency does not know where the pills ultimately ended up. Through a spokeswoman, the agency said the drugs were supposed to be used for patients with lupus, who encountered shortages early in the pandemic.

The FDA withdrew its emergency authorization in June, after it found hundreds of adverse events linked to the drug’s use in covid-19 patients, including dozens of deaths. In June, two months after the White House’s urgent orders to ship the millions of doses of hydroxychloroquine, health officials told holders of the pills in a general notice they could destroy them.

Rick Bright, center, former director of the Biomedical Advanced Research and Development Authority, arrives at the Rayburn House Office Building before testifying about the government response to the coronavirus pandemic on May 14.

Rick Bright, center, former director of the Biomedical Advanced Research and Development Authority, arrives at the Rayburn House Office Building before testifying about the government response to the coronavirus pandemic on May 14. (Chip Somodevilla/Getty Images)

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The government’s Strategic National Stockpile is maintained for pandemics and biological attacks, with large caches of drugs and medical supplies warehoused around the country for rapid deployment. In his whistleblower complaint, Bright alleged that, from the early days of the pandemic, the White House sought to bypass regular emergency response channels and directly control distribution of hydroxychloroquine. Bright alleged in his complaint, which is still pending, that he was removed from his post in part because of his resistance to the Trump distribution plan.

“The whole thing reeked of political pressure to get that stuff” into state health systems, Bright said in an interview after he departed the federal government this month. “There was no scientific reason or rationale. It was completely political.”

Navarro declined to discuss his role in leading the Trump administration’s push to distribute hydroxychloroquine. Despite the FDA’s revocation of its emergency use order, Navarro continues to insist the drug benefits patients in early stages of infection, both in the hospital and at home as outpatients.

“It is one of the great tragedies of this pandemic that the anti-Trump mainstream media demonized a cheap and effective medicine that could have saved tens of thousands of American lives,” Navarro said in an email to The Post. “How that happened is the only story worth writing about. The rest is just political garbage, and I have no interest in participating further in another hit piece timed around the election cycle.”

Trump said in May he was taking the drug as a preventive measure, but when he contracted the novel coronavirus early this month it was not included in the publicly released list of medications he received.

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Navarro was a relentless advocate for hydroxychloroquine in the administration, said Olivia Troye, a former official who served on the staff of Vice President Pence and worked on Trump’s coronavirus task force.

Troye, a public critic of Trump’s pandemic response, said Navarro became visibly irritated at times when other officials would not share his enthusiasm for the drug. He would personally distribute articles and studies around the White House that supported use of hydroxychloroquine to treat covid-19, she said.

“He was really passionate about it,” Troye said. “He was like, ‘Send it out to everyone.’ He was the number one backer of it.”

The anti-malarial drugs in the stockpile were donated by Sandoz, the generic drug division of drug manufacturer Novartis, which dispatched more than 80 million tablets over several months; and Mylan, which is becoming part of Pfizer and donated 10 million.But even as the manufacturers issued news releases calling attention to their large contributions, they made no claims of their effectiveness to treat covid-19. Medical associations and researchers strongly warned against widespread adoption of the untested pills. Hyroxychloroquine, particularly in combination with the antibiotic azythromycin, a cocktail for covid-19 treatment that a handful of doctors promoted, poses a risk of fatal heart arrhythmia in a small percentage of patients, numerous medical studies have found.

Those concerns were cited in the FDA’s March 28 emergency use authorization, which restricted the Strategic National Stockpile supplies of the drug to hospitalized patients and patients in clinical trials only. The agency wanted to be able to monitor outcomes and track adverse events, according to the EUA.

Despite the EUA’s controls, the administration made plans to ship hydroxychloroquine to pharmacies so patients at home could get the treatment on an outpatient basis. In an exchange of internal HHS emails during the weekend of April 4 and 5 discussing a first shipment of 620,000 pills, top officials outlined a plan to send 220,000 tablets to hospitals and 400,000 to pharmacies in the New York City area, Detroit, Chicago and New Orleans. (The April emails were first reported by Vanity Fair and became public in May when Bright included them in his whistleblower complaint.)

Two of the highest-ranking HHS officials — Adm. Brett Giroir, the assistant secretary of health, and Robert Kadlec, assistant secretary of preparedness and response — agreed that the EUA did not limit the intended distribution.

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Under prescribing rules, doctors may prescribe approved drugs for additional “off-label” purposes, meaning for illness other than the approved indications. Hydroxychloroquine has been approved for lupus and rheumatoid arthritis patients for decades.

Giroir, responding to a Strategic National Stockpile official who raised the subject of the EUA limits, was emphatic in an April 5 email that “off-label” outpatient prescribing of hydroxychloroquine was appropriate in the case of covid-19. Giroir is a pediatrician, academic and former hospital administrator appointed by Trump to the rank of four-star admiral in the U.S. Public Health Service.

“NOPE,” 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 added that pharmacies needed the drug for lupus and rheumatoid arthritis as well.

Kadlec answered in a one-word response: “Agree.” Through HHS, he declined to comment.

Food and Drug Administration Commissioner Stephen Hahn testifies Sept. 23 during a Senate Health, Education, Labor and Pensions Committee on Capitol Hill. (Alex Edelman/AFP/Getty Images)

Food and Drug Administration Commissioner Stephen Hahn testifies Sept. 23 during a Senate Health, Education, Labor and Pensions Committee on Capitol Hill. (Alex Edelman/AFP/Getty Images)

FDA Commissioner Stephen Hahn, the top drug safety official, also approved sending drugs to pharmacies, despite his agency’s EUA, according to an email in the same chain from Peter Gaynor, the head of the Federal Emergency Management Agency. Gaynor told the other officials on the email chain that he had spoken to Hahn about the issue by phone. FEMA referred questions to HHS.

The FDA referred a question about Hahn’s actions to a blog post published on the FDA website in May. In that post, Hahn explained that outpatient prescribing was justified despite the EUA limits because donation agreements with Sandoz and Mylan for hydroxychloroquine “allowed for it to be distributed for clinical trials and to the commercial market for use in the outpatient setting, if appropriate.”

Hahn also said in the blog that part of the need for outpatient supplies was to relieve shortages of the drugs for lupus and rheumatoid arthritis patients.

On the Monday after that weekend of emails, an order for more than 9 million pills went from the White House to the stockpile, according to a spreadsheet of hydroxychloroquine distributions provided to The Post in response to a Freedom of Information Act records request.

The April 6 order, relayed via email by a White House aide who worked with Navarro’s staff, resulted in 3 million pills sent to each of the three major wholesale distributors of prescription drugs, McKesson, Cardinal Health and AmerisourceBergen.

A former pharmaceutical executive with one of the three distributors, who is familiar with discussions around hydroxychloroquine distribution and spoke on the condition of anonymity to discuss internal deliberations, said Navarro had been in direct phone conversations with the executive’s company.

The message from Navarro was very clear, the former executive said: “You take it, you send it, you manage the distribution.”