There has been a lot of buzz lately about Congress’ reauthorization of the Prescription Drug User Fee Act, affectionately known as PDUFA (pronounced: pah-du-fa) inside the beltway and in the halls of pharmaceutical and biotech companies. Traditionally, PDUFA is an issue that only D.C. health policy wonks get excited about, as it goes in front of Congress about every five years. But times have changed, especially with the United States public so tuned into health care these days. The once little-known PDUFA reauthorization has been the talk of the health care town and is getting more press nationwide than it has in years past, covered most recently in Forbes by Doug Schoen and in the Washington Post as the “most important health policy you’ve never heard of.” Even patient advocates like NORD are getting in on the PDUFA hype to champion the part of legislation that supports drugs for rare diseases.
I think it’s about time.
For those who are not familiar with PDUFA, here’s a Cliff Notes version as to what it is, why it matters and, most importantly, what it means for patients:
Definition of PDUFA: A law enacted in 1992 and renewed in 1997 (PDUFA II), 2002 (PDUFA III) and 2007 (PDUFA IV), which authorizes FDA to collect fees from companies that produce certain human drug and biological products.