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FDA Kicks off Reauthorization Process for PDUFA

Posted 12 May 2015 | By Alexander Gaffney, RAC

FDA Kicks off Reauthorization Process for PDUFA

The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug products in the US are reviewed.


PDUFA was first authorized in 1992, and has since been reauthorized four times, most recently in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA).

As with FDA's other user fee programs, PDUFA is based on a relatively simple premise. Drug reviews are often time- and resource-intensive for regulators. Drug companies, however, would like to bring their products to market more quickly. Drug companies have therefore agreed to fund FDA's review of their new drugs through substantial user fees meant to allow FDA to hire additional staff. In return for that money, regulators are supposed to review the majority of drugs according to established timelines.

By most accounts, PDUFA has been a successful program. FDA, once a laggard in global drug approvals, now approves drugs substantially more quickly than its global counterparts.

NAS Approval Times

Reauthorization Process Begins

Now regulators and industry are preparing to start the reauthorization cycle for what will be the sixth iteration of PDUFA (PDUFA VI).

As previously explained by Regulatory Focus, FDA's user fee reauthorization processes are quite unusual.

With the exception of trade agreements, Congress is typically the first and last word in any agreement between a government agency (i.e. FDA) and the industries it regulates (i.e. the pharmaceutical industry). But that's not the case with FDA's user fee agreements, which are hashed out in direct negotiations between FDA and each of the respective industries it regulates. Congress is then given the draft of the user fee bill for markup and final approval.

Stakeholders involved in the negotiating process for past user fee agreements have said this process results in an agreement that is tenable for both parties, and prevents the user fee agreements from becoming politicized or heavily modified by legislators lacking a deep understanding of the drug approvals process.

The reauthorization process is also controlled in part by federal legislation, the Federal Food, Drug and Cosmetic Act, which requires FDA to request "public input on the reauthorization" prior to starting any negotiations with industry.

A Public Meeting

The first of those public meetings is now set to occur on 15 July 2015, FDA said in a Federal Register posting on 12 May 2015.

The current authorization for PDUFA is set to end in September 2017, giving regulators and legislators a little more than two years in which to establish a new framework for PDUFA.

Key questions FDA is asking of the public include:

  • What is your assessment of the overall performance of PDUFA V thus far?
  • What current features of PDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the human drug review process?
  • What new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the human drug review process?

FDA said it also "welcomes any other pertinent information stakeholders would like to share."

What to Watch for

As reported previously by Regulatory Focus, the current reauthorization cycle for PDUFA is set to be unlike any prior reauthorization. That's because the pharmaceutical industry's main trade groups, PhRMA and the Biotechnology Industry Organization (BIO), have teamed up to establish a "PDUFA Tracking Database."

As explained by officials from PhRMA and BIO, the new system is intended to give industry the data it needs to press for informed changes to the PDUFA system. Previously, up-to-date information about the state of FDA's review performance was not always timely or easily available.

The PDUFA reauthorization process is also beginning just when legislators are expressing a sustained interest in reforming parts of FDA. The House Energy and Commerce Committee, for example, has unveiled the draft text of its proposed 21st Century Cures Act, which would overhaul the way in which FDA regulates many healthcare products.

The 21st Century Cures Act may ultimately benefit the PDUFA process by clearing a path for the reauthorization legislation and freeing it of many of the legislative add-ons which can raise the chances the must-pass legislation will be delayed or rejected.

A similar reauthorization process is already underway for generic pharmaceutical products.


Federal Register Notice


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