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October 5, 2022

ADVOCACY & DISEASE EDUCATION: PDUFA

Today, I’ve got my “Advocacy” hat on and am writing about PDUFA as it is a vital piece of legislation that all of us need to know about and to advocate for to ensure that PDUFA remains in effect. As many of you know, in June of 2002, my late husband, Christopher Stewart Elliott, lost a hard-fought battle with Glioblastoma/GBM – a rare and aggressive form of brain cancer. After two years of fighting, he passed away still waiting for a cure. Our family’s story is very common despite living in a country that leads the world in new therapeutic development. The pipeline of medical discovery that could give HOPE to millions of patients around the US who are fighting for their lives every day was just renewed as Congress has reauthorized crucial Food and Drug Administration (FDA) funding that will make a difference for other patients like Chris and families like ours. Specifically, the Prescription Drug User Fee Acts, or “PDUFA”, now signed into law by President Biden, ensures the FDA retains its capacity to promote the health and well-being of all Americans for another five years.

Why is PDUFA Important: PDUFA shaves about two years off the average review timeline for new drug approvals to treat illness/disease. The expedited development and approval of the world’s COVID-19 vaccines from US manufacturers wouldn’t have been possible in the pre-PDUFA era. American scientists are pushing the next frontier of medical discovery at a remarkable pace, and our lawmakers have now demonstrated they don’t take those contributions for granted. None of this development is possible without the federal Food and Drug Administration – which plays a key role in ensuring novel bench science translates into safe and effective new medicines.

By reauthorizing FDA funding at this critical moment, Congress has reinvigorated the pipeline of new medicines currently in development and secured a viable approval pathway for those still to be discovered. Even the COVID vaccine was delivered on a platform first developed in response to the Ebola crisis decades ago. Should the COVID virus mutate once again, we’ll need the FDA at full capacity to propel next level therapeutic response. THANK YOU CONGRESS!

As EBCI, formerly the Chris Elliott Fund, celebrates its 20th Anniversary of making IMPACT and increasing patient access, I am proud to share with you that even at the end of his life, Chris was incredibly optimistic about his fight against brain cancer. It was all about “just give me access to the next treatment option”, which leads me to share with you that I am optimistic that lawmakers will continue to fight for patients across the US who are still waiting for the next cure to be discovered.

Photo of Dellann

Dellann Elliott Mydland
President & Board Chair

The EndBrainCancer Initiative | Chris Elliott Fund
Dellann@EndBrainCancer.org

EndBrainCancer.org

This Cover Tip is the last one for this year and I hope you find it informative and appreciate EBCI and my “Calls to Action” to continue to help support our Advocacy & Disease Education mission, programs and daily work. If you do, please go to www.EndBrainCancer.org to donate to support this 501 (c)3 non-profit organization’s efforts to create lasting positive change and access to our healthcare system and to research.

ENDBRAINCANCER INITIATIVE | CHRIS ELLIOTT FUND

Enhancing patient outcomes by expanding FDA-approved treatment modalities and fueling research in the pharma/bio/life sciences, device & diagnostic industries and by closing the existing GAP from initial diagnosis to IMMEDIATE AND EXPANDED ACCESS to specialists, researchers, advanced & innovative treatments, clinical trials and critical care with the ultimate goal of improving patient outcomes through updating and improving WHO & NCCN Guidelines and clinical practices related to Standard of Care for brain cancer patients.

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