BIO Board member testifies at House hearing in Salt Lake City

Good Day BIO is evolving. Over the summer, Bio.News will bring you a weekly digest every Monday at 10 A.M. ET, plus breaking news alerts as needed. This transition period will allow us to analyze feedback and analytics and develop even better communications to meet your needs. 

This week: BIO Board member Frank Watanabe's testimony at a House hearing, an exclusive interview with Sen. Richard Burr on the legacy of Project BioShield, the latest on bird flu and PBMs, and how you can follow the RNC, which kicks off today. As always, we're keeping it tight, at 811 words, 4 minutes, 3 seconds.

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BIO Board member, BioUtah testify at House hearing in Salt Lake City

A BIO Board member and the head of BioUtah told lawmakers how they can support biotech innovation at a July 12 House Ways and Means Committee field hearing in Salt Lake City. Bio.News has a full recap.

Who and what: Arcutis Biotherapeutics President and CEO Frank Watanabe, a BIO Board member, and BioUtah President and CEO Kelvyn Cullimore discussed legislative proposals to undo troubling provisions of the Inflation Reduction Act (IRA), tax policy to incentivize research and innovation, and more.

Why it matters: “In the last quarter century, American life expectancy has continued its steady increase upwards, with roughly one-third of that improvement directly attributable to biopharmaceutical innovations,” said Watanabe’s written testimony.

The big picture: The industry’s direct and indirect contribution to the U.S. GDP is anywhere from 2-7%, with an economic impact of $2.9 trillion in 2021. Biotech capabilities enhance national security by ensuring we can care for ourselves.

Legislative proposals that would support innovation include:

• The Ensuring Pathways to Innovative Cures (EPIC) Act, which would give small molecule drugs the same 13-year protection from price controls as biologics, and the ORPHAN Cures Act, which would exempt orphan drugs from price controls even if approved for more than one indication.
• The Tax Relief for American Families and Workers Act (H.R. 7024), which was passed by the House earlier this year, to restore the R&D tax deduction.
• Allow for monetization of net operating losses (NOLs) and reform Section 382 on NOLs.
• Improve the capital gains exemption under Section 1202 to encourage investment in small biotechs.
• Ensure strong strong patent protections and reasonable regulation of M&A activity. 

Lawmakers were supportive—Bio.News highlights key exchanges with Committee Chair Jason Smith (R-MO), Rep. Blake Moore (R-UT), and Rep. Kevin Hern (R-OK).

Read and share the Bio.News story.

As Project BioShield turns 20, BIO calls for PAHPA reauthorization

Ahead of the 20th anniversary of Project BioShield on July 21, Bio.News interviewed former Sen. Richard Burr on Project BioShield’s legacy and the urgent need to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA).

What’s Project BioShield? Legislation to help the U.S. respond to chemical, biological, radiological, and nuclear threats. Project BioShield provides funding and incentives to expedite R&D, procurement, and stockpiling of medical countermeasures like vaccines, therapeutics, and diagnostics—including many in the past 20 years that might not have been developed otherwise.

Why it matters: “This novel public-private partnership program has brought the biotechnology industry together with the U.S. government to improve our country’s readiness for potential chemical, biological, radiological, and nuclear national security threats,” said Phyllis Arthur, BIO’s EVP and Head, Healthcare Policy and Programs, at a May 8 reception on Capitol Hill to mark Project BioShield’s anniversary.

What’s PAHPA? Born from Project BioShield to bolster our defenses against the next generation of global health threats, “PAHPA was the architecture for Project BioShield to happen within the legislative government,” former Sen. Richard Burr (R-NC) told Bio.News. PAHPA must be renewed every five years.

The bottom line: “We must advance biotechnology as a national security imperative,” said BIO President & CEO John F. Crowley at the Capitol Hill event, “and we need to do that because it’s important for pandemic preparedness.”

Read and share the Bio.News story.

What Else to Read This Week

ICYMI: FTC to sue PBMs. Last week, the Wall Street Journal reported the Federal Trade Commission (FTC) plans to sue the three largest pharmacy benefit managers: UnitedHealth Group’s OptumRx, Cigna Group’s Express Scripts, and CVS Health’s CVS Caremark. Combined, they handle about 80% of prescriptions. “The agency plans to file lawsuits taking aim at business practices related to rebates brokered with drug manufacturers,” reported the WSJ. Catch up on our recent coverage of the FTC’s report on PBMs.

We can’t ignore bird flu. The Colorado Department of Public Health and Environment reports that three poultry workers in northeast Colorado are believed to be positive for H5N1. If the tests are confirmed positive, this would bring the total to seven human infections this year. On Friday, Agri-Pulse hosted a timely webinar last week on zoonotic pathogens, hosted by BIO member Boehringer Ingelheim, and Nature takes a deep dive into how countries are preparing for a potential avian flu pandemic—and we say it’s all the more reason to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA).

Beltway Report: What's Ahead in Washington

Just two days after former President Trump survived an assassination attempt, the 2024 Republican National Convention begins today in Milwaukee, where Trump reportedly rewrote his convention speech to focus on unity. POLITICO has a good summary of what you need to know to follow the week’s activities and speeches.

Meanwhile, President Biden and Vice President Harris kick off the week with a briefing from homeland security and law enforcement, and Biden will sit down with NBC’s Lester Holt.