It was the HIV/AIDS public health crisis of the 1980s when health advocates realized the Food and Drug Administration’s 25-to-30-month drug approval process was costing lives. In response, Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992 to provide a framework for the prescription drug approval process that allows the FDA to confront and respond to advances in therapeutic discovery and pressing public health concerns.
As we near a September deadline for Congress to renew crucial FDA funds that support patients across the world, I urge swift passage of PDUFA reauthorization.
The prescription drug act reduced drug application review times by half and shaved an average two years off the wait time for “priority medicines.” Rapid deployment of today’s effective and innovative COVID-19 vaccines is proof that this policy infrastructure is still vital in maintaining our health and well-being.
The global health community is centered on ensuring that the benefits of advances in health care are accessible to everyone. Washington’s global health community has made an immense contribution toward meeting the urgent health care needs evolving across the global community. The rapid, global spread of new COVID variants that impact the entire globe is a strong indication that this role is as vital and important today as it was 30 years ago.
Today, the urgency to develop new medical interventions can be felt in the same way it was in response to HIV/AIDS and COVID. For many patients with untreatable diseases around the world, every day is March 2020.
To meet these health challenges, the Global health community works to bring together partners from the private sector, the public sector, local research institutions, the nonprofit sector, and academia to create and deploy new medical science. This work yields important economic benefits to our region as well.
Collectively, 196 Washington-based companies account for more than $6 billion in local economic output, indirectly supporting an additional $4 billion of economic activity in adjacent industries. More than 41,000 Washingtonians are employed by our vibrant global health community, and these organizations contribute more than $361 million to our state’s tax revenue on an annual basis.
There is no policy tool more important to ensuring that we have the robust, innovative biopharmaceutical industry that we need to respond to today’s health care challenges than PDUFA.
A new therapeutic innovation can have a 10-plus-year time horizon from bench science to commercial development and typically requires billions in private investment over that time frame to move through necessary clinical trial phases. The federal funding streams that guarantee the FDA has the expertise and capacity to process new product applications must be reauthorized every five years to keep our ecosystem of new discovery healthy and productive. When a pharmaceutical company applies for approval from the FDA for a new therapeutic product, it pays both application and program fees that allow the agency to have a stable, consistent source of funding to fulfill its mission to protect and promote public health.
For Washington’s global health community, this has huge implications. Once a therapeutic comes to market in the U.S., its availability can inform programmatic opportunities the world over. While COVID has certainly instigated a resurgent focus on mitigating the impacts of infectious diseases, rising rates of chronic illnesses and cancer demand a more complex array of interventions that can scale internationally. The pipeline of new discovery that might save a patient’s life overseas starts in the U.S., and increasingly, right here in Washington state.
U.S. Sen. Patty Murray is leading the effort to shepherd PDUFA through the Senate. There appears to be a great temptation among some of her colleagues to attach unrelated or politically risky policy amendments to this “must-pass” legislation. To her credit, Sen. Murray has managed to keep the legislation focused on its core mission — spurring the innovation that has and will continue to save and improve lives. Good for her.
I urge her and her colleagues to bring PDUFA reauthorization swiftly to President Joe Biden’s desk, so the global health community in this Washington can continue making a world of difference at home and abroad.