Nope, we’re not joking!
US SWAT teams (Special Weapons And Tactics, military weapons-equipped law enforcement teams) have been asked to step in to help with backlogged FDA applications to get experimental treatments designated as orphan drugs.
Despite the absurdity of a law enforcement unit associated with violent crisis management, this is a good sign! Because the real news behind the SWAT’s involvement is that rare diseases are being more noticed by the FDA than they previously have been!
The “orphan disease” designation means that those drugmakers who develop treatments get government incentives (such as tax credits) to do so. An orphan disease is a rare disease that affect fewer than 200,000 people; and therefore do not often get a lot of attention by pharma companies.
Rare diseases have become a fast-growing niche in pharma, helped partially by these incentives but also because the drugs’ prices have increased. But any news where overlooked diseases get attention is a big deal! In fact, the FDA has seen a big increase in applications, which more than doubled in four years.
“Congress gave us tools to incentivize the development of novel therapies for rare diseases and we intend to use these resources to their fullest extent in order to ensure Americans get the safe and effective medicines they need, and that the process for developing these innovations is as modern and efficient as possible,” according to Scott Gottlieb, the FDA commissioner.
And so what exactly will these SWAT teams be doing?
The teams are tasked with getting through the backlog of 200 requests – and answering any new requests – within 90 days. Not as exciting as assisting in bomb threats or hostage situations – but just as important, if not more!
Read the whole article in Bloomberg here.
