Saturday, June 13, 2015

An upcoming way for rare-disease patients in the U.S. to get access to FDA-approved meds

In the U.S., we've all known the frustration of not getting insurance approval to take FDA-approved meds -- because these drugs haven't been specifically approved for Behcet's

That situation might finally change.

A bill called the "OPEN Act (the Orphan Product Extensions Now) Act" will, if it's passed later this month as part of the "21st Century Cures Act,"allow FDA-approved drugs to be used off-label for diseases they weren't originally approved for. It would give drug companies financial incentives to re-label their already-approved drugs as FDA-approved treatment for "rare diseases." 

This bill was created by U.S. Rep. Gus Bilirakis (FL). According to Bilirakis, "The OPEN Act would unlock a new world of potential treatments and put FDA-approved, safe and effective treatments "on-label."' Insurance companies would then be able to pay for the meds, and it would also allow rare-disease patients to get access to the FDA-approved drugs they need.

If you want to read more (and encourage your own representatives to support the bill), it's here: AND here:

Joanne Zeis