Comment: Renewal of FDA bill restores hope for drug innovations

By Dellann Elliott Mydland / For The Herald

In June of 2002 my husband, Christopher Stewart Elliott, lost a hard-fought battle with glioblastoma; 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 still 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 U.S. who are fighting for their lives every day was just renewed as Congress has reauthorized crucial Food and Drug Administration 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, ensure the FDA retains its capacity to promote the health and well-being of all Americans.

Advocates for patients living with HIV/AIDS in the 1980s made the first successful case for better funding of U.S. institutions tasked with responding to another deadly, rapidly spreading disease. Though under duress from a different pandemic at that time, it was taking the FDA nearly three years to bring new medications to market; at great cost to families who were losing their loved ones to AIDS. In response to an outcry from advocates and patients about the FDA’s lengthy review times, Congress passed the first of the Prescription Drug User Fee Acts in 1992; and has successfully reauthorized this same legislation every five years since then.

PDUFA shaves about two years off the average review timeline for new drug approvals. The expedited development and approval of the world’s covid-19 vaccines from U.S. manufacturers wouldn’t have been possible in the pre-PDUFA era. American scientists are pushing the next frontier of medical discovery at 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.

The huge boost in research propelled by the passage of PDUFA in the early 1990s ultimately laid the foundation for modern responses to other immunological conditions. Many of our contemporary medicines that treat diseases like rheumatoid arthritis share an origin with treatments first targeted against AIDS. 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 virus mutate once again, we’ll need the FDA at full capacity to propel the next population level therapeutic response.

Washington’s own Sen. Patty Murray has done yeoman’s work to move PDUFA reauthorization over the finish line during a contentious election year with many competing federal priorities. Her state delegation colleagues — Rep. Kim Schrier, D-8th District, and Rep. Cathy McMorris Rodgers, R-5th District — also played an important role. Families who are counting on medical breakthroughs should take comfort in the investment Congress just made into supporting our life science discovery ecosystem.

Even at the end of his life, Chris was relentlessly optimistic about his fight against brain cancer. Though we had to return to different hospitals many times during his illness for successively more invasive and debilitating treatments, he’d always keep pushing to the next treatment step with unbelievable grace and good spirits.

We wouldn’t accept the many times that doctors told us, “there’s nothing more to be done”; and Chris outlived the prognoses of his doctors several times over. There’s always something more to be done, and I am optimistic that lawmakers will continue fighting for patients across the U.S. still waiting for the next cure to be discovered.

Dellann Elliott Mydland is the president and chair of the EndBrainCancer Initiative and the Chris Elliott Fund, in Redmond.