Guest Blog: The Campaign For Modern Medicines Discusses PDUFA

Now that we’re ramping up our PDUFA campaign in anticipation of reauthorization this year, we thought it might be nice to review the basics of PDUFA. In this post, we’ll talk about what exactly PDUFA does, what’s at stake during its reauthorization, and how Congress can get PDUFA right. If you don’t know, think of this as PDUFA 101.

What is PDUFA?

The Prescription Drug User Fee Act (PDUFA) was first passed by Congress in 1992 to allow the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies. These fees allow the FDA to hire new employees and invest additional resources in making their drug review process safer and more efficient.

When PDUFA works, it creates a regulatory environment that is predictable, transparent, and institutes accountability for the FDA. This allows the pharmaceutical industry to deliver safe and innovative cures and treatments that will help people live longer, healthier, and more productive lives. It also ensures America’s position as the global leader in drug innovation.

For example:

  • More than 2,900 medicines are in clinical trials or being reviewed by the FDA today, vs. 1,800 in 1999. America currently has more potential treatments in clinical trials than the rest of the world combined.
  • Last year, the FDA approved 35 breakthrough treatments, making 2011 one of the highest approval periods in the last decade. Those 35 treatments included seven major innovations in cancer research; the first new treatment for Hodgkin’s lymphoma in 30 years; and the first new treatment for lupus in over 50 years.
  • Since 1993, over 1,000 new drugs have been approved, including treatments for cancer, metabolic and endocrine disorders, neurological and psychiatric disorders, and cardiovascular and renal diseases.
  • Median review times for priority review drugs has been cut in half; for standard applications, review time has decreased by 37%.

What is at stake with PDUFA Congressional reauthorization?

The current user fee agreement, PDUFA IV, expires on September 30, 2012. Congress must reauthorize PDUFA by that date in order to keep the program operational. In past reauthorizations of PDUFA, Congress made legislative changes that reduced its effectiveness and impaired the FDA’s ability to review new drug applications efficiently, ultimately delaying safe, innovative medicines from getting to patients. These changes increased drug review times and meant that the FDA met only one-third of its review performance goals.


Without the proper regulatory environment in place, America will lose the innovation race and will fail to realize all of the critical health and economic benefits that new medicine research, manufacturing, and delivery can bring.

That’s why it’s important that this time, Congress reauthorize a clean PDUFA, free of unnecessary legislative burdens. To us, a clean PDUFA is one that stays faithful to the technical letter agreed upon by patient and consumer groups, industry representatives, and the FDA. Over the last year, we’ve seen real consensus that this agreement will improve the drug review process and provide the FDA with the additional resources it needs to safely and efficiently deliver new medicine to patients.

How can Congress get PDUFA reauthorization right?

As Congress considers PDUFA in the next few months, we need to ensure that Congress does not turn PDUFA into a vehicle for costly, unrelated legislation. The focus of PDUFA V is to enhance the FDA’s ability to safely review and approve innovative new drugs; burdening PDUFA with unnecessary changes that don’t focus on this mission would cause unnecessary delays in getting medicines to the patients who need them.

A clean PDUFA V will enable the FDA fulfill its mission of speeding safe and effective treatments to patients, and enhance America’s position as the global leader in developing innovative new medicines. Congress should act in a responsible and timely manner and pass a clean PDUFA V without unnecessary legislative additions.

As PDUFA’s reauthorization date grows closer, we encourage you to stay involved with our campaign via FacebookTwitter, or email. We strongly believe that PDUFA will greatly improve the FDA’s drug review process, holding the FDA accountable for speeding safe, innovative treatments to patients, and ensuring that the U.S. maintains its position as a global leader in the discovery of new treatments and cures.

For more on the Campaign for Modern Medicines, please visit:




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