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Regulatory Focus™ > News Articles > 2020 > 4 > Harvard professors call on FDA to maintain review standards amid COVID-19

Harvard professors call on FDA to maintain review standards amid COVID-19

Posted 15 April 2020 | By Michael Mezher 

Harvard professors call on FDA to maintain review standards amid COVID-19

In a perspective published in the New England Journal of Medicine Tuesday, Harvard professors Benjamin Rome and Jerry Avorn call on the US Food and Drug Administration (FDA) to maintain its drug approval standards amid the coronavirus disease (COVID-19) outbreak.
Rome and Avorn express concern about the agency’s issuance of an emergency use authorization (EUA) for chloroquine and hydroxychloroquine following President Donald Trump’s promotion of the drugs as potential game changers, despite limited evidence to support the drugs’ efficacy. (RELATED: FDA EUA Allows States to Receive Unapproved COVID-19 Treatments, Regulatory Focus 30 March 2020).
The authors note that this is only the second time FDA has issued an EUA for a drug during a public health emergency, following its EUA for peramivir amid the 2009 H1N1 influenza outbreak. Under that EUA, peramivir was provided to some around 1,200-1,500 severely ill patients, “with no rigorous tracking of which patients received it or collection of outcome data.”
The vast majority of EUAs issued during public health emergencies have been for diagnostics. FDA has also issued EUAs for drugs in the past as medical countermeasures to address specific health threats, such as anthrax and nerve agent poisoning.
Rome and Avorn point out that hydroxychloroquine is approved for other indications in the US, clearing the way for off-label use without the need for an EUA and that investigational products can already be provided to patients outside clinical trials through expanded access protocols.
“These developments represent fundamental threats to the US drug-evaluation process. Advocating that the FDA should quickly approve drugs without randomized trial data runs counter to the idea of evidence-based medicine and risks further undermining the public’s understanding of and faith in the drug-review process,” Rome and Avorn write, noting that the statutory basis for drug approval in the US is substantial evidence of safety and efficacy from adequate and well-controlled clinical trials.
The authors stress that rigorous evidence can be generated rapidly from well-designed studies. “The most relevant clinical outcomes for evaluating these drugs—including death, hospitalization, number of days spent in intensive care, and need for a ventilator—are readily assessed and available within days or weeks,” they write.
Rome and Avorn also argue that any “truly effective” treatment for COVID-19 could be reviewed and approved by FDA in a matter of days or weeks, citing the agency’s coronavirus treatment acceleration program. (RELATED: New FDA Program to Accelerate Coronavirus Treatments, Regulatory Focus 31 March 2020).

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