When Donald Trump took office earlier this year, he promised to bring some big changes to the US healthcare system. Along with slashing drug prices, and making health insurance more affordable and accessible for all Americans, President Trump has also sworn to make important medications more readily available to the patients who need them the most.
To help achieve this goal, President Trump has proposed a complete revamp of the US Food and Drug Administration (FDA), the federal agency charged with reviewing new drugs for market use. The president has openly lamented the FDA for its “slow and burdensome” drug approval process, claiming that there are far too many regulations and restraints in place that prevent patients from accessing novel drugs in a timely manner.
However, according to a recent study published in the New England Journal of Medicine, the FDA actually approves more drugs, at a faster rate, than the European Medicines Agency (EMA), the equivalent drug approval agency in Europe.
The study results show that, in the time period between 2011 and 2015, the FDA approved 170 new drugs while the EMA approved only 144. Furthermore, the FDA had a median review time of 306 days, while, at the EMA, there was a median review time of 383 days. Encouragingly for rare disease patients in the US, there were considerably more orphan drug approvals at the FDA than there were at the EMA. 43.5% of the approved agents in the US were orphan drugs, while in Europe, only 25% were orphan drugs.
This is definitely good news for the US FDA. While such positive data does not imply that the FDA is perfect, or that there is no room for improvement, it does confirm that, despite the President’s narrative, the FDA is more effective and efficient than other similar agencies around the world.
As such, as President Trump nominee, Scott Gottlieb, gets ready to take over as the new FDA commissioner, Americans can take comfort in knowing that any changes made at the FDA will only improve upon a system that does in fact work well.