Good Day BIO: ‘Patient-centric, effective, and inclusive’

It’s a health-heavy Friday, with a recap of what BIO’s Dr. Cartier Esham told a House panel yesterday about PDUFA and patient-centric drug development and a new letter urging HHS to reject a “march in” petition for a prostate cancer drug. (710 words, 3 minutes, 33 seconds)

‘Patient-centric, effective, and inclusive’

Those should be the goals when modernizing the clinical development paradigm, BIO’s Chief Scientific Officer Dr. Cartier Esham told a House panel yesterday—here’s how we can get there.

The hearing: The U.S. House Energy & Commerce Subcommittee on Health held a hearing yesterday, The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight, covering Prescription Drug User Fee Act (PDUFA) riders. BIO’s Chief Scientific Officer Dr. Cartier Esham testified—here’s her prepared testimony.

Accelerated approval was front and center, with many Members (and Dr. Esham) noting it’s a key pathway for innovative cures.

“If we want to have drugs approved that treat diseases before symptoms appear, it requires accelerated approval,” said Ranking Member Cathy McMorris Rodgers (R-WA). “I cannot support anything that undermines this important pathway.”

All witnesses support the creation of ARPA-H—the Advanced Research Projects Agency for Health—a new agency under NIH to “improve the government’s capability to speed research,” Friends of Cancer Research’s Dr. Jeff Allen explained. (ARPA-H has bipartisan support, too, though Members have different views on how it should operate.)

There’s also bipartisan support for improving clinical trial diversity—with Subcommittee Chair Anna Eshoo (D-CA) saying they’re considering bills that would require trials to report to FDA a diversity action plan and address barriers to participation, among others.

Read: Working together to make clinical trials inclusive

We can’t forget antimicrobial resistance—“one of the leading causes of death globally,” with “unique challenges” for drug development, said Dr. Esham. “We urge enactment and passage of PASTEUR this year to…drive and sustain much-needed investment in this space.” 

Watch the highlight reel:

P.S. Want to know more about accelerated approval and the recent CMS decision on certain Alzheimer’s treatments? Today, March 18, Biocom California and Vital Transformation will hold a virtual briefing on the proposal and new research on how it would impact patients—click here to register.

100 experts urge HHS to reject march-in petition

They explain why yet another petition asking the government to “march in” on a prostate cancer drug under the Bayh-Dole Act should be rejected (again).

Remind me, what’s Bayh-Dole? The bipartisan Patent and Trademark Law Amendments Act empowers universities, small businesses, and non-profits to own and license inventions made with federally funded research—to turn basic research into tested and approved products.

The government can “march in” and force additional licenses under limited circumstances—but not because “someone doesn’t like the price of a resulting product,”Bayh-Dole Coalition Executive Director Joe Allen explains. March-in petitions based on price have been rejected by Democratic and Republican administrations. 

But a recent petition asks NIH to do exactly that: “force licensing to additional parties of the prostate cancer drug Xtandi, because of its cost,” says Allen—even though previous petitions based on price for this very drug have been rejected.

“The purpose of the Bayh-Dole Act was not to create a mechanism for the federal government to set prices on successfully commercialized products,”says a letter to Health and Human Services Secretary Xavier Becerra, signed by nearly 100 academic and private-sector innovation experts and organizations, legal scholars, and policy organizations (including BIO).

“The petition flagrantly misrepresents the meaning of the Bayh-Dole Act,” said Allen. “The Act’s purpose is to facilitate the commercialization of technologies developed from federally funded inventions—not to serve as a backdoor for price controls of successfully developed inventions.”

Just look at the numbers: “Bayh-Dole has spurred 13,000 startups, resulted in more than 100,000 new patents, and led to the disclosure of more than 420,000 inventions just from 1996-2017,” reported Bloomberg Law—as well as some 300 drugs on the market.

More Health Care News:

The New York Times: As virus data grows, the J&J vaccine holds its own
“[N]ew data suggest that the vaccine is now preventing infections, hospitalizations, and deaths at least as well as the Pfizer-BioNTech and Moderna vaccines.”

Happy National Biodiesel Day

We’re running a bit long today—but we didn’t want to forget about National Biodiesel Day, celebrated on the birthday of Rudolf Diesel, inventor of the diesel engine. 

Diesel’s come a long way since the first diesel engine was tested in 1897—thanks in part to biotechnology, which is allowing us to create sustainable, low-carbon biofuel and biodiesel to power our world.

We’re now making more history—with the world’s first passenger flight using 100% renewable fuel taking off last year. 

Learn more about what biotech’s doing to clean up the transportation sector.

President Biden’s Friday: He spoke with President of China Xi Jinping this morning, and this afternoon, he’ll meet with researchers and patients to discuss ARPA-H before heading to Rehoboth Beach, Delaware, for the weekend. 

What’s Happening on Capitol Hill: It was a whirlwind week—enjoy the weekend.