The U.S. Food & Drug Adminstration (FDA) hit the fast lane as it struck a 21-year high in new drug approvals for 2017, more than double the previous year.
The 46 new medicines include treatments for rare diseases and subcategories of cancer. Drugs designated as “breakthrough therapy” reduce review times and increase competition by approving multiple drugs that have similar effects…more choices can provide insurers ways to reduce prices on historically expensive drug therapies.
The number of approved drugs could have been higher in the U.S., but cell and gene therapies that also got the go-ahead were not included in the tally (of 46) because they were under a separate category.
FDACommissioner Scott Gottlieb calls drugs in that category: “a whole new scientific paradigm for the treatment of serious diseases.”
Gottlieb, using recent department policy changes, pushed for the sped-up approval process. Let’s see if we keep the stride in 2018.
Read more of the story from Reuters here.