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.

Several people pushed unsuccessfully for federal legislation concerning the regulation of food and drugs in the USA at the turn of the 19th century. The most notable people are Peter Collier and Dr Harvey Wiley, the latter also being known as the ‘Crusading Chemist.’ Unfortunately, it took the occurrence of two separate tragedies in 1901 for the public to become involved, demanding justice and stricter regulations, for legislation to be enacted. Two tetanus outbreaks involving the deaths of 21 children in Camden, New Jersey, and Saint Louis, Missouri, were caused by tainted smallpox vaccines and diphtheria antitoxin serums, respectively. These tragic incidents led to the first pharmacoepidemiologic investigation in the USA and the first working legislation concerning drugs: the Biologics Act of 1902.