CEOs, Senators: Drug revenues drive U.S. innovation

We recap what biopharma CEOs said on Capitol Hill yesterday, and the launch of a new cloud-based platform that would streamline information and data exchange between drug developers and regulators worldwide. (698 words, 3 minutes, 29 seconds)

Drug revenues enable U.S. biotech innovation, say Senators, biopharma CEOs

Here’s the gist of what biopharma CEOs told the Senate Health, Education, Labor & Pensions Committee yesterday: Drug revenues enable U.S. leadership in lifesaving innovation. And while net drug prices have declined, pharmacy benefit managers (PBMs) are driving up costs for patients.

The kickoff: Warning against a hearing focused on “sound bites,” Ranking Member Bill Cassidy, M.D. (R-LA) stressed drug revenues drive innovation, noting Canadians do not have access to the full range of specialty treatments available in the U.S. He pointed out other areas for reform, like 340B, which resulted in $54 billion in drug discounts in 2022—but we don’t know if those discounts reached patients.

What the CEOs said:

• New prices from drug makers have declined, while PBMs keep patient and payer prices high, said Johnson & Johnson CEO Joaquin Duato. (Bio.News has reported the same.)
• Cancer mortality has dropped 33% since 1991 due to drugs like Keytruda—and revenues fund R&D enabling these breakthroughs, said Merck CEO Robert Davis. He urged policy solutions to help patients afford drugs, like out-of-pocket caps and “smoothing.”
• Bristol Myers Squibb CEO Chris Boerner said his company’s investments have led to innovations in cell therapy, cardiovascular disease, and schizophrenia—and the U.S. accounts for most new medicines. He also called for policy solutions that lower costs for patients.

The key topics covered:

• Inflation Reduction Act (IRA) price controls: Sen. Tommy Tuberville (R-AL) noted the IRA’s “pill penalty” wrongly discourages small molecule drug development.
• Bipartisan support for PBM reform: Sens. Robert Casey, Jr. (D-PA), Tim Kaine (D-VA), Roger Marshall (R-KS), and Mitt Romney (R-UT) all called for PBM reform.
• How we fund innovation: In questioning, Merck’s CEO highlighted the company’s investment of billions into technology enabling conversion of difficult-to-manufacture “large molecules” into less expensive, oral small molecule drugs. Sen. Rand Paul (R-KY) said drug price controls reduce lifesaving innovation.

What’s next: Sen. Kaine said the Senate would act “soon” on the committee’s Pharmacy Benefit Manager Reform Act.

More News:

BioCentury: "BIO blasts anti-China biotech bills"
“Anti-China biotech bills recently introduced in the House and Senate would, if enacted without modifications, inflict serious harm on the U.S. biotech industry and on the patients who rely on it to develop medicines, BIO warned in a letter sent Thursday to the chair and ranking member of the Senate Committee on Homeland Security & Governmental Affairs.”

Accumulus launches cloud-based platform to streamline information exchange between drug developers and regulators

Accumulus Synergy just announced the launch of its cloud-based platform to support real-time information and data exchange between drug developers and regulators—a first step in the organization’s mission “to dramatically accelerate critical therapies to citizens of the world,” says Accumulus CEO Frank Nogueira.

The news: In a Roche-led Reliance Pilot that follows World Health Organization (WHO) principles of good reliance practices, regulatory authorities from six continents are using the platform to submit questions and receive answers from drug developers on a Post-Approval Change (PAC) submission. 

Why it matters: By streamlining information exchange and promoting regulatory harmonization while prioritizing data security and confidentiality, the platform can dramatically reduce the time it takes to get new innovations to patients worldwide.

The details: Q&As occur in a central location visible to all participants, allowing greater transparency among authorities, while exchanges are reduced as interactions move from one-to-one to “one-to-many.”

Who’s involved:Accumulus Synergy is a global nonprofit industry association enabling enhanced collaboration and efficiency between life sciences companies and global regulatory authorities, with the goal of getting medicines to patients faster by leveraging cloud technology. Sponsors include a dozen major biopharmaceutical companies (and many BIO members).

What they’re saying: “This advancement could potentially expedite access to cutting-edge medicines by nearly two years, offering a significant advance for patients facing life-threatening conditions such as breast cancer,” said Ralf Altenburger, Senior Vice President, Cell and Gene Therapy and Global Head of Pharma Technical Regulatory at Roche. 

Learn more and get involved at www.accumulus.org.

President Biden’s Friday: Meeting German Chancellor Olaf Scholz at the White House for discussions likely to focus on Ukraine, per AP.

What’s Happening on Capitol Hill: A quiet end to a busy week.