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.
Why it Matters:
1. Access to new prescription treatment options depends on PDUFA, including how fast patients have access
- PDUFA reauthorization means that the FDA drug approval process will continue to move as quickly as it has over the past two decades, due to increased FDA staffing to review and make decisions about drug applications. This means that for drugs with a standard review, the time from submission to an FDA decision is about ten months, and those drugs with a priority review will hear from the FDA within a six-month time frame.
2. Quicker availability of generic drugs and biosimilars (those drugs that are almost identical to current biologic drugs)
- Currently, it takes about 30 months for approval of a generic drug through the system. As you can imagine, this is holding up the availability of affordable medicines for millions of patients.
- And, for biosimilar treatments, a new system is proposed to expedite reviews and approvals of this relatively new classes of medicines.
- Lastly, one of the most important parts of PDUFA is to lessen the backlog of work that’s created by the collision of an innovative industry and the U.S. Federal Government.
- PDUFA legislation is a prime example of how government can adapt to meet the changing needs of our society, ensuring that patients have quicker access to the medicines they need.
There are currently three bills carrying the PDUFA language in the current 112th Congress with dual party support. On the Senate side, S.2516 and S.3187, championed by Senator Tom Harkin (D-IA), and on the House side, H.R. 5651, championed by Representative Fred Upton (R-MI).
On another note, researchers from Yale and the Mayo Clinic just published data showing that the U.S. FDA approved more new medicines in less time than Europe and Canada in the last decade, including an approval process that is about 15 percent faster than the EMEA or Health Canada.
It certainly is not often (if ever) that the FDA is showcased in a positive light, alongside the progress over the past 20 years with PDUFA and third-party data that backs it up. My message to FDA: live it up while you can!