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Regulatory Focus™ > News Articles > History of Charging for Investigational Biological Products

History of Charging for Investigational Biological Products

Posted 01 December 2010

In 1630, a certain Nicholas Knopp of Massachusetts "was fined five pounds, or was whipped, for vending as a cure for scurvy 'a water of no worth or value,' which he 'solde att a very deare rate.'"1 This is the earliest example of government action on a drug in the Colonies referenced by the US Court of Appeals for the District of Columbia Circuit in its ruling that there is no constitutional right to investigational new drugs.2 Formal regulation of drugs in what would become the US began when the Colony of Virginia's legislature passed an act in 1736 that addressed the dispensing of more drugs than was "necessary or useful" because that practice had become "dangerous and intolerable."3

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