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The case for creating excess capacity at the US Food and Drug Administration


Jeffrey Clemens, Parker Rogers
The public and political pressure on vaccine developers and global regulatory approval agencies has never been higher. The world has been eagerly awaiting any – and all – developments regarding vaccines and therapeutics required to fight the current Covid-19 pandemic. While the demand side is willing to pay almost any price for an effective and fast solution, unfortunately neither the drug development nor the drug approval process is designed to deliver speed and safety free of trade-offs. 
The dilemma faced by the regulators is simple. If regulators rush their review, they may end up approving a drug without adequately understanding its efficacy and safety, leaving room for unforeseen side-effects. These include safety issues around the drug itself, along with treatment dangers such as unsafe dosages and failing to highlight potentially dangerous drug interactions. Yet if regulators endeavour to understand all possible scenarios, it may ....

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