FDA Focus: The Sherley Amendment

In the fourth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at the history of the FDA in the historic Shirley Amendment.

Today, new applications for marketable drugs undergo a strict, lengthy, all-encompassing process of testing for safety and efficacy. The US Food and Drug Administration stands as a prime example of an agency that stringently conducts and/or oversees this process. However, it was only a hundred years ago that the USA was plagued by a plethora of ‘snake oil salesmen,’ and the government of the day was beginning its long and arduous battle to bring control and transparency to the new-found booming drug trade. Various potions, oils, powders and ointments were for sale as a remedy for every illness or malady imaginable – some being marketed as a panacea or cure-all. Not only were peddlers selling a cornucopia of ‘medicines’ using unverified claims that often had no basis in reality, but some of these ‘medicines’ were dangerous and even lethal.