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Fostering Indiana’s Biopharmaceutical Innovation Starts with Extending PDUFA

Every day, patients across our state and around the country benefit from medicines developed and distributed by Indiana’s biopharmaceutical companies. Whenever you pick up your prescription at your local pharmacy—that’s our industry hard at work. And while the process might appear seamless on your side of the counter, it’s actually extremely complicated. From the first clinical trial to the packaging and transportation for distribution, there are numerous steps involved in getting your prescriptions from the manufacturer to your medicine cabinet.

But despite that complexity, the biopharmaceutical industry is only getting more efficient. Medications are now approved and distributed faster than ever before. In 2022 alone, we experienced a 10% efficiency boost from two years prior – thanks in large part to the Prescription Drug User Fee Act (PDUFA).

PDUFA is a law—initially passed in 1992—that allows the Food and Drug Administration (FDA) to keep pace with the many innovative new drugs being produced. For over 30 years, this program has advanced the access and development of Indiana’s public health, essentially reinventing the FDA approval process and establishing rules of the road which allow the biopharmaceutical industry to operate efficiently. By providing companies with the sustainable funding to innovate, the program has delivered countless opportunities for companies to develop new patient treatments.

The program is so effective that it’s easy to forget that this tremendous success hasn’t always been the norm. Prior to 1992, it took the FDA two or more years to approve a drug. Under PDUFA, that time has dropped to just ten months­—and continues to decline. 

Indiana needs PDUFA; our state’s biopharmaceutical industry prospers because of it—as does everyone dependent on prescription medicines and innovative medical treatments. This program is crucial for fostering patient healthcare and promoting research and development. Without it, we would be putting the lives of Hoosier patients at risk. And that’s precisely why, come September, Congress can’t allow PDUFA to expire.

Our state’s biopharmaceutical industry couldn’t have made the progress it has without PDUFA. The extent of Indiana’s medical success speaks for itself. Data shows the state’s life science industry ranks among the top 10 nationally. Since 1999, the industry has conducted more than 3,260 clinical trials that have significantly benefitted patients. Over half of these trials target some of the nation’s most debilitating diseases, such as cancer, heart disease, and diabetes. In many cases, this progress has led to the development of new treatments, cures, and biologics that save lives and improve the health of countless people.

Thanks to PDUFA, patients are the priority. It allows the biopharma industry to create a stronger patient focus in drug development. Access to up-to-date equipment, new facilities, and advanced technology enables companies to innovate. These modern tools contribute to a thorough, effective, and efficient drug approval process that caters to patient safety by meeting their medical needs.

Hoosier patients are counting on Congress to protect this impressive progress we’ve made. We can’t go backward. PDUFA VII’s renewal in September is essential to the well-being of millions of Americans. Let’s make sure it gets done.

Kevin Schaefer currently serves as President and COO of Schaefer Technologies Inc.


Inside Indiana Business with Gerry Dick – Fostering Indiana’s Biopharmaceutical Innovation Starts with Extending PDUFA


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