WASHINGTON, D.C. (August 13, 2026) - Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl issued the following statement today on the release of the Prescription Drug User Fee Act (PDUFA) VIII performance goals letter:

"Since 1992, PDUFA has fostered an efficient, predictable and science-based regulatory ecosystem. As a result, more than 70% of new medicines are approved in America first, and the FDA's human drug review program is the global gold standard for regulatory review and approval.

"The PDUFA VIII agreement strengthens America's competitive edge by reducing unnecessary review delays, embedding modern regulatory science tools into standard review and increasing program accountability. The goals letter reflects sustained collaboration between the FDA, industry, patient groups and other stakeholders to bolster America's regulatory ecosystem.

"We encourage Congress to move swiftly to reauthorize PDUFA. It is essential to maintaining American patients' early access to new medicines and keeping innovative drug development in the U.S."

The proposed PDUFA VIII agreement:

• Reduces delays by providing opportunities for earlier and more frequent FDA feedback throughout the regulatory review process.

• Helps enable the FDA to keep pace with scientific innovation by incorporating modern evidence, technology and regulatory science tools into standard review practice.

• Strengthens public trust by improving accountability and transparency around how user fees are spent and how the program performs.

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies, which are focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. PhRMA member companies have invested more than $850 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States.

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For information on how innovative medicines save lives, please visit:
www.PhRMA.org
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www.VotersforCures.org
www.AmericasMedicines.com
www.LinkedIn.com/Company/PhRMA
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