Good Day BIO: House package to reauthorize FDA user fee agreements

House Energy & Commerce released a bipartisan package to reauthorize the Prescription Drug User Fee Act (PDUFA) and other user fee agreements—here’s what we know. Plus, we have news about how biotech is improving the tomato and other essential ingredients for Cinco de Mayo. (648 words, 3 minutes, 14 seconds)

House unveils package to reauthorize FDA user fee agreements

The House Energy & Commerce Committee yesterday “unveiled a comprehensive legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements”—here’s what we know.

The bipartisan package reauthorizes the Prescription Drug User Fee Act (PDUFA) and other user fee agreements, and includes provisions “to support patients by lowering costs and providing a clear path for innovators, such as improvements and program integrity for Accelerated Approval, requirements regarding clinical trial diversity, policies to improve generic drug competition,” and more, per the committee's press release.

Why it matters: “For more than thirty years, the FDA user fee programs have shown tremendous results in delivering life-saving medicines to patients who urgently need them,” says BIO’s Chief Scientific Officer Dr. Cartier Esham, who testified before the House and Senate earlier this year.

“While we are still analyzing the bill, we are pleased to see bipartisan support from the Energy & Commerce Committee for these critical public health programs,”she continues in her statement. “We are further encouraged that the Committee recognizes the importance of a timely reauthorization and has worked together to develop a bill that will continue the shared goal of transforming and improving patients’ lives for years to come.”

The next steps: The Energy & Commerce House Subcommittee is planning on a vote “next week,” with the goal of sending the bill to President Biden for signature before August, per the announcement.

Catch up: PDUFA is “critical to advancing innovation”

Speaking of innovation, big news you might have missed a few weeks ago:FDA approved Kite Pharma Inc.’s Yescarta, the first CAR T-cell therapy for initial treatment of relapsed or refractory large B-cell lymphoma (LBCL). Patients on the drug were “2.5 times more likely to be alive at two years without cancer progression or need for additional cancer treatment”—read more.

How biotech is saving Cinco de Mayo

What’s Cinco de Mayo without tomatoes? Thanks to biotech, we shouldn’t ever have to know.

The news: University of Florida researchers have discovered the genetic pathway to a tomato with better flavor and aroma without sacrificing yield and fruit size, reports Bio.News.

Why it matters: “Now that we know how these compounds are made in tomatoes, we can identify varieties that have the heirloom version of the enzyme and high levels of these flavor compounds, and we can breed this trait into modern tomatoes to improve flavor,” said one of the researchers.

It’s not the only way biotech’s improving the tomato—gene editing’s also allowing us to produce tomatoes that can lower blood pressure and resist disease.

Soon, our salsa will be healthier, tastier, and resilient in the face of climate change—but biotech’s also tackling the whole enchilada, developing corn that can withstand hot, dry weather, rice with a higher yield, and even non-browning avocados.

The big picture: With climate change and supply chain challenges threatening our food supply and putting us on the path to a global food crisis, biotechnology offers solutions to ensure we have nutritious, delicious, and resilient food for the future.

More Agriculture and Environment News: 

Agri-Pulse: UK wants a trade pact and it's seeking to negotiate
“We appreciate Secretary Eustice’s comments that the United Kingdom intends to take a science-based approach to the regulations of agricultural biotechnology and keep the politics out of its decision-making. BIO looks forward to working with the U.S. and U.K. governments to achieving this outcome in a future trade agreement," said BIO's Sarah Gallo. By Subscription 

President Biden’s Thursday: Hosting a Cinco de Mayo reception with Mexico’s First Lady Beatriz Gutiérrez Mueller de López Obrador. On the global stage, the WTO formally unveiled the “outcome” of the agreement on a waiver of COVID-19 vaccine intellectual property protections, with the goal of achieving a final deal by June, Reuters reported.

What’s Happening on Capitol Hill: The Senate Commerce, Science, and Transportation Committee will hold a hearing on pharmacy benefit managers (PBMs)—read our recent explainer on PBMs and how they impact drug prices.