It’s no question we are in a new era of medicine. From personalized medicine to the most advanced cancer therapies that utilize the patient’s own immune system to fight disease, treatments which just a few years ago seemed like science fiction are today reality.
American patients in particular are fortunate enough to be able to typically access new treatments months or even years before patients in other countries. In fact, America leads the world in new medicine approvals and availability of treatments.
But it hasn’t always been this way. Just a few decades ago, more than 70% of medicines were first approved outside the U.S. Back then, inefficient regulatory procedures and rules surrounding intellectual property (IP) made it difficult for biopharmaceutical companies to deliver innovative medical treatments to patients in a timely manner.
In the 1980s and ‘90s, Congress passed a series of laws that helped unify, modernize and support the U.S. ecosystem of medical innovation. These laws have brought the landscape we have today, in which more than half (57%) of new medicines come from the U.S. In 2018 alone, of the 59 new medicines approved by the U.S. Food and Drug Administration (FDA), 42 were first approved in the U.S. before receiving approval in any other country.
Take, for instance, the Prescription Drug User Fee Act (PDUFA),which allows the U.S. Food and Drug Administration (FDA) to collect user fees from biopharmaceutical companies to help support the regulatory review process for new medicines. PDUFA was enacted by Congress in 1992 in response to a bottleneck of new medicine approvals that left patients waiting for years—29 months, on average—for an under-staffed and under-funded FDA to review new drug applications. PDUFA has been transformative in accelerating patient access to innovative new therapies. Now, more than 27 years after the law was first passed, the average FDA approval time for a new medicine is just 10 months.