Nicholas Downing, a student in the School of Medicine’s Class of 2014, has been named one of Forbes magazine’s 30 most influential people under the age of 30. In 2011, as a first-year student, Downing began comparing the speed with which the U.S. Food and Drug Administration (FDA) approves new drugs to the speeds of drug approval by comparable agencies in Europe and Canada.
His work, funded by the Pew Foundation and published in 2012 in The New England Journal of Medicine (Downing is one of the youngest-ever first authors published in the prestigious journal) showed that, contrary to popular belief, the FDA was faster than regulators in other countries at approving new medicines.
The report concluded that given the FDA’s lead over its peer institutions, criticisms about the inefficiency of the agency’s review process for novel drugs may be unfounded.
The idea for the FDA study emerged from the impending reauthorization of the Prescription Drug User Fee Act (PDUFA), which was first enacted in 1992 to allow the FDA to collect fees from drug companies to fund the process of new drug approval.
Downing says that his study “injected some objective information into what had become a relatively subjective debate.”