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Congress has a unique opportunity this year to strengthen America’s status as a world leader in medical innovation, which has been a jobs powerhouse in the United States for the past two decades.
The U.S. biopharmaceutical sector pumps out almost $1 trillion in economic production each year and supports more than 4 million jobs here at home. The world’s best and brightest researchers, scientists and engineers continue to come here to develop the next generation of lifesaving medicines and therapies.
But it took hard work to get where we are today. In the 1980s, a sluggish U.S. regulatory system was slow to respond to new innovations in medical research. With a backlog of drug applications piled up at the Food and Drug Administration, drug manufacturers looked to other countries to conduct research and development. Biotech jobs flourished overseas. And, not surprisingly, more than 70 percent of all new drugs were first made available in other countries. This meant European patients often had access to new therapies before American patients.
Simply put, America was losing. The length of review times at the FDA literally meant the difference between life and death for U.S. patients. Manufacturers couldn’t recoup the enormous costs of research and development because there was little certainty in the U.S. regulatory process. Everyone agreed — industry, patients and the FDA itself — that it took far too long for the FDA to review a new drug application and make a decision.
Congress confronted this problem in 1992 by passing the bipartisan Prescription Drug User Fee Act. PDUFA created a mechanism to increase resources to the FDA from user fees paid by drug manufacturers. The goal of PDUFA was to create a more efficient, predictable review process for new medicines without compromising the FDA’s gold standard for safety. In doing so, Congress sent a signal to entrepreneurs all over the globe that America wanted to be the home of medical innovation.
By all accounts, PDUFA has been a resounding success. This unique user fee program has enabled the FDA to hire more reviewers, upgrade its information technology system and put in place a modern regulatory structure. Review times for new drugs have dropped more than 60 percent since its passage — from more than two years to just less than a year. Patients in the United States have had quicker access to more than 1,500 new medicines to treat diseases such as heart disease, cancer and diabetes.
PDUFA has been reauthorized three times since 1992, each time making a successful program even better. Past reauthorizations have improved the FDA’s communication with product sponsors and patient advocacy groups, set faster performance goals for drug reviews and enhanced the review of safety information to monitor side effects of drugs already on the market.
The FDA’s authority to collect user fees under PDUFA expires in October. To preserve America’s status as the world leader in medical innovation, Congress must quickly pass a reauthorization of PDUFA.
The FDA and the industry have negotiated a strong package of reforms, including new funds for regulatory science initiatives that will help the FDA to keep pace with the latest scientific discoveries. The agreement would also support drug development for rare diseases by enhancing the FDA’s ability to review therapies for smaller patient populations.