In a recently published white paper, the Institute for Economic Review (ICER) and University of Chicago researchers examined four proposed policies and how they could shape the rare diseases research and access landscape. The paper, entitled “The Next Generation of Rare Disease Drug Policy: Ensuring Both Innovation and Affordability,” is available for free download.
According to the AJMC, “In 1983, Congress passed the landmark Orphan Drug Act (ODA), which created financial incentives to encourage companies to develop new drugs for rare diseases, including tax credits to offset some research and development costs; eligible products receive an extended 7-year market exclusivity. However, in recent years, these products and their pricing have come under intense scrutiny, as several reports have noted that drugs with the orphan drug designation generate much of their use—and their resulting revenue—through expanded indications for diseases that are not rare.”
Click here to read more and find a download link.
(Source: AJMC, April 14th, 2022)