Now in an interview with the "Financial Times," FDA head Dr. Stephen Hahn is quoted as saying they would consider possibly using them again, to approve an early release of a coronavirus vaccine. But to understand where that power comes from, you have to turn the clock back to another major American crisis.
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The historic attacks of September 11 may seem to have little in common with the COVID-19 crisis. But 9/11, and the mysterious Anthrax attacks that followed, triggered a series of emergency laws that wield critical power today.
"There was considerable concern in the Bush administration that we would be attacked again," says retired Rear Admiral, USPHS, Kenneth Bernard, M.D.
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Dr. Bernard helped head up a special bioterrorism team in the wake of 9/11. Their mission resulted in a wide ranging law called the BioShield act of 2004. Among their first priorities was to create a pipeline of vaccines as quickly as possible.
"Of course it sped things up, because the biggest impediments to moving a new product to the market are the testing for the safety and the efficacy," explains Dr. Bernard.
First, millions of federal dollars poured into a market-fund for vaccine development. Pharmaceutical companies were ultimately granted protection from most liability, in follow-up legislation. And the Secretary of Health and Human Services along with the FDA were given special authority to speed the release of promising drugs and vaccines before the normal course of clinical trial, using a device known as an E.U.A., or emergency use authorization.
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"The Emergency Use Authorization gave the government the ability to declare a health emergency or a need for that product that was more important than the full licensure process," says Dr. Bernard.
And flashing forward, that fast track power may be even more critical today. The BioShield powers and those of related bills are now the legal driver for much of the government's emergency Covid 19 response. The Federal funding system kick started a race for a Covid vaccine that's proceeding at an unprecedented pace. And Golden Gate University Law professor Kathleen Morris says it's also empowered federal agencies.
"In many ways, it's like a lot of laws where congress delegates broad authority to a federal agency, to solve a specialized problem," says professor Morris.
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But the Trump administration has wielded other BioShield powers early and often with some mixed results. An emergency use authorization for the drug Hydroxychloriquin, touted by the President, was ultimately reversed. While another for the use of convalescent blood plasma was ultimately approved after a back and forth over the scientific data. And now come published reports that the administration may consider a fast track release of a vaccine, possibly before the November election. While the BioShield laws do provide emergency power, professor Morris says oversight responsibility ultimately rests with Congress.
"And that if someone starts to act in bad faith, congress will step and do something about it," she explains.
Dr. Bernard says he's proud of what BioShield has accomplished in the decades since 911, and in battling the COVID-19 crisis. He's also hopeful that the checks and balances in place will ensure its used responsibly in the weeks and months ahead.
"Scientists reaching out from everywhere, giving counter arguments when they think that the national leadership has gone off line, especially on the science," he points out.
Protecting a set of powers that may be needed to protect America again in the future.
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