Normally, when someone says “PDUFA,” your first inclination is to reply with a “bless you.” But PDUFA, or the Prescription Drug User Fee Act, is actually an incredibly important piece of legislation.
The act has silently paved the way for decades of groundbreaking treatments reaching the marketplace in the HIV/AIDS community, as well as to cancer patients and others that suffer from other chronic diseases.
Passed in 1992, PDUFA was a monumental step in easing the burden on the Food and Drug Administration when it came to the approval of new medications. We all remember the stories back in the late ’80s and early ’90s of patients having to go overseas to get treatment for a disease because a certain drug or medication was not yet approved in the United States.
PDUFA addressed that problem by collecting fees from drug manufacturers and applying those funds towards staffing, data development and other areas that needed to be streamlined. The result was an easing of the bottleneck for new, life changing drugs that have saved countless lives of patients like ours at Aunt Rita Foundation.
The data backs it up.
Before PDUFA, the average FDA approval on a new medicine stretched to more than two years. After passage, that approval time dropped to just 10 months. In fact, in the 30-plus years since PDUFA (and its subsequent supplemental versions) passed, the United States has become the first country to approve a novel drug roughly 75% of the time.
It is no coincidence that our country has become a leader on the innovation that is showing so much promise when it comes to HIV/AIDS, Alzheimer’s and Epilepsy.
It’s rare to find a piece of legislation that brought all the stakeholders to the table in order to fix a problem that has stood the test of time like PDUFA has.
Drugmakers, government and patients have all found that this solution is the best way to get biopharmaceutical innovations out of the labs, into the approval process, and out to patients in a timely matter. Our leaders must continue to support this program, and they will have the chance to.
PDUFA version VII must be authorized by September. The previous versions have passed through bipartisan support, and hopefully this version will be no different. With COVID-19 teaching these industries many lessons on best practices, this new version will place a renewed focus on strong review principles, greater transparency from all parties, and incentivizing new cures for rare diseases.
These past three decades have built tremendous momentum when it comes to using technology to foster innovation in public health. Arizona leaders would be wise to continue on that path and support a passage of a clean and efficient PDUFA.
Editor’s note: Jimmy Thomason is the executive director of Aunt Rita’s Foundation, a non-profit organization in Phoenix. Learn more at: auntritas.org.
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