Stephen Hahn (oncologist)

Hahn being sworn in on December 17, 2019

Hahn speaks to the White House press corps on the COVID-19 pandemic on April 24, 2020

On November 1, 2019, U.S. President Donald Trump announced his intent to nominate Hahn to be Commissioner of Food and Drugs Administration.[11][12][13] On December 3, 2019, the Senate Health Education Labor and Pensions Committee voted 18 to 5 to advance the nomination to the Senate floor.[14] On December 12, 2019, the Senate confirmed his nomination by a 72–18 vote.[15] Hahn was sworn in on December 17, 2019.[16]

Hahn has factored prominently in the Trump administration's response to the novel coronavirus pandemic in the United States, although the FDA under his administration has also been criticized for a lethargic response to the rapidly emerging outbreak in the United States.[17] By November 2020, Hahn had gained the confidence of individuals concerned about the politicization of the DA.[18]

On March 1, 2020, Vice President Mike Pence and Health and Human Services Secretary Alex Azar announced the addition of Hahn to the White House Coronavirus Task Force.[19]

According to a whistleblower complaint filed by HHS infectious disease expert Rick Bright, in April 2020, Hahn instructed FEMA administrator Peter Gaynor "to distribute hydroxychloroquine to pharmacies nationwide," even though the emergency use authorization (EUA) issued by the FDA did not provide for outpatient use of hydroxychloroquine for COVID-19.[20] Hydroxychloroquine was later linked to multiple deaths of COVID-19 patients,[21] and the FDA revoked the EUA in June 2020.[22]

On July 5, 2020, Hahn refused to defend Trump's false claim that 99% of coronavirus cases are "totally harmless"; in response to an interview question about the president's claim, Hahn said, "I'm not going to get into who is right and who is wrong."[23][24]

On August 23, 2020, Hahn joined with Trump and Azar in announcing an emergency authorization for the use of coronavirus convalescent plasma in treating COVID-19.[25] As with hydroxychloroquine, Trump publicly exerted major pressure on the FDA to approve convalescent plasma as a COVID-19 treatment, even suggesting that "deep state, or whoever over at the FDA" was blocking the authorization.[26] The approval came a few days after Trump publicly complained that the agency was moving too slowly on plasma and suggested they might be delaying the approval for political reasons. In fact, the delay was due to concerns at the National Institutes of Health that the treatment's effectiveness had not been adequately demonstrated.[27] Hahn has said that Trump "has asked FDA to cut back red tape and try to speed medical products into the hands of providers, patients and American consumers."[25] In making the announcement Trump exaggerated plasma's effectiveness compared to the FDA's own assessment, and Hahn did not correct him.[25] After coming under criticism from scientists and former FDA officials for echoing Trump's exaggerated claims about the benefits of convalescent plasma, Hahn issued an apology/correction, saying, "The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction."[26][28]

The FDA was criticized in the beginning stages of the pandemic in the U.S. for moving slowly and bureaucratically in approving COVID-19 tests developed by laboratories, prompting concerns from academic medical centers and others.[29] On February 29, 2020, the FDA allowed laboratories to begin using tests after validation, but still required emergency use authorization applications.[29] Over the following months, the FDA approved many COVID-19 tests, including lab-developed and non-lab-developed tests. In August 2020, the Trump administration blocked the FDA from regulating COVID-19 tests and a wide array of other laboratory tests.[29] The move was strongly opposed by Hahn and the FDA, and came after rising tensions between Hahn and Azar.[29] The sudden move was criticized by public health experts, who stated the change could lead to more unreliable or defective coronavirus tests entering the market, and pointed out that testing shortages were by that point primarily attributable to shortages of swabs, chemical reagents, and other supplies, rather than a lack of approved tests.[29]

After controversy over the hydroxychloroquine and plasma authorizations, Hahn transferred two political appointees from the top public relations and communications posts at the agency, replacing them with career civil servants on an acting basis. Emily Miller, the agency's top spokesperson, who had no prior medical or science experience, was removed on August 28 after just two weeks on the job.[30] On September 2 John "Wolf" Wagner, a close ally of chief DHS spokesman Michael Caputo, was removed from his post as FDA's associate commissioner for external affairs after serving for two months.[31]

Hahn left office on January 20, 2021.[32]