Good Day BIO: Why PDUFA VII matters

The U.S. Food and Drug Administration (FDA) recently released the Prescription Drug User Fee Act (PDUFA) VII commitment letter—and BIO supports it. Here’s what’s in it and why it matters.

What’s PDUFA?The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect “user fees” from companies that produce certain human drug and biological products, which are used to expedite the drug approval process. 

PDUFA must be reauthorized every five years—and it’s currently authorized through September 2022. The PDUFA VII commitment letter outlines performance goals and procedures for the reauthorization for FY23-27.  

The PDUFA VII agreement achieves the following objectives:

• Strengthens scientific dialogue between FDA and industry to promote innovation
• Enhances patient-centric drug review and supports the next wave of advanced biological therapies (i.e., cell and gene therapies)
• Modernizes regulatory and drug development tools, including advancing the use of real-world evidence for regulatory decision-making
• Advances digital technology tools and modernizes FDA’s information technology infrastructure, including the adoption of cloud-based systems and capabilities
• Improves innovation in manufacturing and quality, including lessons learned from COVID-19
• Enhances FDA hiring, retention, and financial management systems

BIO supports the letter,said BIO’s Chief Scientific Officer Dr. Cartier Esham in a statement issued yesterday. “We believe it achieves our goals of strengthening scientific dialogue between FDA and industry as well as promoting innovation and a patient-centric review process.”  

The next steps: On September 28, FDA will hold a virtual public meeting to discuss the proposed enhancements. BIO looks forward to working with the FDA, Congress, patient groups, and all other stakeholders to ensure timely reauthorization of the PDUFA package.

Read BIO’s full statement.

Learn more about PDUFA.

If we’ve learned anything this summer, it’s that we’re out of time—we must act on climate change. Luckily, COP26 is coming up—and we have more on how your company can get engaged in the race to end carbon emissions.

COP26, or the UN Climate Change Conference of the Parties, kicks off October 31 in Glasgow and will bring parties together to accelerate action on the Paris Agreement and the UN’s climate change framework. 

It’s the 26th such meeting in three decades—but many believe it’s “the world’s best last chance to get runaway climate change under control.” 

Reaching net zero is critical—which is why it’s important for as many companies as possible to join the UN-backed Race to Zero, an alliance committed to halving global emissions by 2030 and reaching net zero by 2050. Already, more than 3,000 businesses have joined. 

And the biotech industry is a leader when it comes to climate action—not only developing climate change solutions but also committing to decarbonize their operations, as Biogen and AstraZeneca (to name just two) have done.  

“It’s not enough to be thinking about one individual company’s movement,”says Paul Rennie, OBE, Head of the Global Economy Group at the British Embassy in D.C. “It’s about what that company can tell us about its wider supply chain.”  

So, how can your company get involved in COP26 and the Race to Zero? Paul Rennie and Professor Jason Snape, Head of Environmental Protection at AstraZeneca, joined the BioHealth Innovation BioTalk to discuss—listen at Apple, Google, Spotify, or TuneIn.

Read: Why companies committing to net zero are winning the race

Listen: Fighting the climate crisis through supply chain sustainability

President Biden’s Wednesday: Meeting with his national security team to get the latest information on Afghanistan. This afternoon, he’ll meet with members of his Cabinet, his national security team, and private sector and education leaders to discuss improving cybersecurity nationwide. The President will then sign into law H.R. 1448, the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act, and H.R. 3642, awarding a Congressional Gold Medal to the Harlem Hellfighters, a Black infantry regiment that “fought against Germany's forces longer than almost any other American WWI soldiers,” per The Hill. 

What’s Happening on Capitol Hill: The House is back in session this week and narrowly passed the $3.5 trillion budget in a 220-212 vote, ending a standoff between moderate Democrats and House leadership, according to The Wall Street Journal. Democrats plan to pass the budget through the reconciliation process, which would not require Republican support in the Senate as long as all 50 Democratic senators vote in favor it. Now, a Sept. 27 deadline has been set to vote on the $1 trillion bipartisan infrastructure deal that was passed in the Senate, per CBS News. The Senate still stands adjourned until Sept. 13.