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Jill Wechsler is Pharm Exec's Washington Corespondent
After revoking its Emergency Use Authorization for medicines thought to treat COVID=19, the FDA is looking to regain credibility.
The biomedical health community blasted FDA’s decision in March to authorize emergency use of malaria drug hydroxychloroquine (HCQ) and its earlier version, chloroquine (CQ), to treat patients seriously ill from COVID-19. Medical authorities cited a lack of evidence of effectiveness for these products and ongoing concerns about adverse effects on patients with cardiac problems. The situation exposed FDA to charges of responding to White House pressure to make the drugs more widely available, as advocated by President Trump, difficulties aggravated by missteps by the agency’s new commissioner Stephen Hahn, who was criticized for failing to address shortages and failures in authorizing effective diagnostics able to track the spread of the COVID-19. HCQ use emerged as a political issue between conservatives seeking open access to any promising medicine, and Democrats charging the Trump administration with ignoring science and medical authorities to promote favored remedies.
Now FDA has revoked its Emergency Use Authorization (EUA) for these medicines, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronovirus and raise continued concerns about cardiovascular safety risks. Furthermore, FDA warned health care providers not to administer HCQ with remdesivir, as the combination may reduce antiviral activity of that drug, which appears to provide some benefits for COVID patients [see https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-warns-newly-discovered-potential-drug-interaction-may-reduce].
The reversal of this closely-watched drug access policy appears to reflect efforts by Commissioner Hahn to assert FDA’s independence in basing decisions on objective scientific measures. In a presentation to the Alliance for a Stronger FDA June 1, Hahn emphasized his reliance on “rigorous data in support of advancing innovation and discovery” and that agency approval decisions must be based on good science for the American public to “have confidence in the products regulated by the FDA.” Hahn also acknowledged that when he came to FDA at the beginning of the year he was unprepared to handle a health emergency “of this magnitude” but has learned much over recent months [see https://www.fda.gov/news-events/speeches-fda-officials/remarks-commissioner-stephen-hahn-md-covid-19-pandemic-finding-solutions-applying-lessons-learned].
However, Hahn left it to his staff to announce the EUA revocation, staying out of the limelight – or avoiding the line of fire. FDA deputy commissioner for medical and scientific affairs Anand Shah said the policy change was based on “the most trustworthy, high-quality, up-to-date evidence available.” And FDA revoked the EUA following “a rigorous assessment by scientists,” added Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research (CDER) following Janet Woodcock’s move to Operation Warp Speed [see https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and].
The EUA repeal was applauded by public health officials, even though FDA had limited use of HCQ to health professionals treating hospitalized patients with confirmed COVID-19 in an effort to minimize broader adverse events. FDA officials explained in March that permitting access to some 3 million pills donated to the strategic national stockpile managed by the Biomedical Advanced Research and Development Authority (BARDA) would help address mounting shortages of the drug, which was needed for its approved use in treating patients suffering from lupus and rheumatoid arthritis, and that such emergency use did not represent approval of the drug for a new use [see https://www.statnews.com/pharmalot/2020/04/24/fda-woodcock-hydroxychloroquine-covid19-coronavirus/].
At the same time, former BARDA director Rick Bright lost his job, allegedly due to his refusal to implement administration demands to authorize a much broader expanded access policy for HCQ, as outlined in Bright’s whistle-blower filing against HHS [see
]. Bright praised FDA officials for supporting the EUA that limited use to hospital care and now gains credibility from the agency conclusion that HCQ is “unlikely to produce an antiviral effect,” as stated in the formal revocation letter from FDA chief scientist Denise Hinton to BARDA [see https://www.fda.gov/media/138945/download].
FDA’s policy change may not halt use of HCQ to treat COVID patients, as it remains available in large quantities in many hospitals and may be prescribed by physicians for off-label uses. More than 100 clinical trials have been launched to test HCQ with other therapies, although the World Health Organization and European regulators have halted many studies. At the same time, HHS secretary Alex Azar interpreted the EUA revocation as opening the door to broader use of HCQ, while White House trade policy advisor Peter Navarro scolded FDA bureaucrats for blindsiding the administration, according to press reports. The situation has reignited calls to make FDA an independent agency, similar to the Social Security Administration, to protect its decision-making processes from political interference. Such a move has been proposed in the past amidst policy controversies and remains one way to separate regulatory decisions from changing political preferences.