The Catalyst

West Virginia becomes the first state to lower patient costs by sharing the savings

Scott LaGanga — Tue, 20 Apr 2021 17:30:41 GMT

In a historic moment for patient affordability, last week West Virginia became the first state in the nation to adopt ground-breaking legislation, HB2263, requiring insurers and their PBMs to share the savings they negotiate on medicines directly with patients.

What they are saying: Experts highlight the importance of IP in recent NIST proposal comments

Megan Van Etten — Tue, 20 Apr 2021 14:30:10 GMT

Strong, reliable, and clearly defined intellectual property (IP) protections are the foundation of America’s robust innovation ecosystem that patients across the globe rely on for the research and development of new cures and treatments. Those protections were reinforced with the passage of the Bayh-Dole Act in 1980, a bipartisan piece of legislation that established a clearer framework for public-private partnerships. Recently, the National Institute of Standards and Technology (NIST) accepted comments on the proposed rulemaking as it pertains to implementing parts of the Bayh-Dole Act.

PhRMA member companies share how they are improving clinical trial diversity

Dr. Freda Lewis-Hall — Wed, 14 Apr 2021 13:00:00 GMT

As part of the biopharmaceutical industry’s efforts to improve health outcomes for patients in underserved communities, PhRMA member companies are identifying ways to improve clinical trial diversity and reduce barriers to participation for Black and Brown communities. As these efforts continue to take shape, our industry is developing potential best practices and key learnings that we are excited to share as part of our effort to tackle these challenges head on.

Our three-part approach to build a better health care system

phrmaceo@gmail.com (Stephen J. Ubl) — Tue, 13 Apr 2021 09:00:00 GMT

On April 3, more than four million Americans received a COVID-19 vaccine — the largest single-day vaccination event in human history. For innovators across the pharmaceutical industry, these moments make the years — sometimes decades — of painstaking trial and error worth it.

ICYMI: New CBO Report highlights biopharmaceutical leadership in the development of new treatments and cures

APowaleny@phrma.org (Andrew Powaleny) — Mon, 12 Apr 2021 17:00:00 GMT

America’s biopharmaceutical companies are at the heart of a research and development (R&D) ecosystem that develops more innovative medicines than any other country in the world. The ongoing development of new, life-saving and life-improving medicines, including those for COVID-19, would not be possible without the robust investment, scientific expertise and manufacturing capabilities from biopharmaceutical research companies.

Diversifying clinical trials and fighting disease requires equity and trust

RMarklund@phrma.org (Rebecca Marklund) — Mon, 12 Apr 2021 14:00:00 GMT

The COVID-19 pandemic has left no person unaffected, but Black Americans have been disproportionately impacted. Black adults are nearly four times more likely to be hospitalized from the virus and nearly three times more likely to die from the virus than their white counterparts. At the same time, recent polls highlight COVID-19 vaccine hesitancy within Black communities. In fact, only one in four Black Americans (24%) plan to get the vaccine compared to other racial and ethnic groups, and Black Americans are significantly trailing in vaccination rates.

Key excerpts: PhRMA submits comments to NIST in effort to safeguard intellectual property protections

Megan Van Etten — Fri, 09 Apr 2021 14:30:00 GMT

Earlier this week PhRMA submitted comments to the National Institute of Standards and Technology (NIST) regarding the proposed rulemaking on implementing regulations of the Bayh-Dole Act. Passed in 1980, the Bayh-Dole Act was a landmark piece of bipartisan legislation that established a uniform framework across the federal government to encourage technology transfer between universities and the private sector that has facilitated timely and efficient commercialization of early-stage research. Since its passage, it has fueled unprecedented innovation across the United States.

Strengthening a culture dedicated to patients and equity: A conversation with Vas Narasimhan, CEO of Novartis

phrmaceo@gmail.com (Stephen J. Ubl) — Wed, 31 Mar 2021 17:00:00 GMT

This year our industry has been working around the clock to combat the COVID-19 virus, including developing effective therapeutics to treat COVID-19 and vaccines to prevent future infections. Outside of the novel coronavirus, major social issues have been brought to the forefront of public discourse. We understand that systemic racism is as real as any disease and our industry is not immune. We need to stand up to racism and injustice because failing to do so impacts our collective wellbeing. Our industry is committed to learning and leading us forward.

Data shows that keeping a strong biopharmaceutical industry is important to Americans

Mark Keida — Tue, 30 Mar 2021 13:00:00 GMT

The United States biopharmaceutical industry continues to innovate and discover critical solutions for our toughest health challenges such as the COVID-19 pandemic. America’s global leadership has not been by chance, but rather the result of a well-planned effort to facilitate innovation by incentivizing and protecting inventors and supporting collaboration between and among the public and private sectors.

New report demonstrates the growing importance of partnerships in advancing biomedical innovation

Abigail Lore — Wed, 24 Mar 2021 13:00:00 GMT

As we mark a full year since COVID-19 was declared a global pandemic, it’s impossible to overstate the significance of collaborations. The unprecedented level of strategic collaborative efforts that have taken place across the biopharmaceutical ecosystem have been central to efforts to ensure efficient development, manufacture and distribution of critical COVID-19 vaccines and treatments. The coronavirus outbreak has brought new attention to the importance of these innovative cross-stakeholder partnerships. A new report from PhRMA looks broadly at the collaborative ecosystem and illustrates biopharmaceutical industry’s long history and vast experience with a diverse breadth of collaborative efforts.

Cross-country comparisons of medicine prices are like comparing apples to oranges

NLongo@phrma.org (Nicole Longo) — Mon, 22 Mar 2021 19:08:36 GMT

Looking at differences in medicine prices between the United States and other countries can be misleading, often ignoring the complexities in the U.S. system and the repercussions of other countries’ reliance on government price-setting policies. As the discussion unfolds, here are five often overlooked facts that are critically important to keep in mind.

Building confidence in the COVID-19 vaccine through education

Megan Van Etten — Mon, 22 Mar 2021 13:30:00 GMT

Throughout the COVID-19 vaccine research and development process, the biopharmaceutical industry has worked to uphold the highest standards of research, clinical testing and manufacturing.

ICYMI: Bipartisan lawmakers urge new administration to oppose changes to six protected classes policy

Tom Wilbur — Thu, 11 Mar 2021 17:31:26 GMT

On January 19, 2021 – the last full day of the Trump administration – CMS released a Part D Payment Modernization Model Request for Applications (RFA) for calendar year 2022. This model would provide “formulary flexibility” by exempting participating Part D plans from some of Part D’s formulary coverage requirements. These requirements include rules for the six “protected classes” and the two drugs per class requirements.

Getting the 340B program back on track in 2021

NLongo@phrma.org (Nicole Longo) — Wed, 10 Mar 2021 15:00:00 GMT

As our nation continues to fight a global pandemic, the need for access to affordable and quality health care feels even more pressing. This is especially true for vulnerable patients who have been disproportionately impacted by COVID-19. That’s why it has never been more important for policymakers to ensure federal programs, like the 340B program, are benefiting the safety net that serves our underserved communities. Unfortunately, nearly three decades after it was originally created, the 340B program no longer resembles its original mission.

ICYMI: WSJ showcases breakthrough science of COVID-19 vaccines and implications for future medicines

APowaleny@phrma.org (Andrew Powaleny) — Mon, 08 Mar 2021 16:51:44 GMT

Building on deep scientific knowledge gained from decades of experience with viruses such as MERS, SARS, influenza, HIV and Hepatitis C, biopharmaceutical companies have made unprecedented progress in advancing treatments and vaccines to help fight COVID-19. At this time, three vaccines and several treatments have received emergency use authorizations (EUAs) from the U.S. Food and Drug Administration (FDA) with one treatment receiving FDA approval. Additional candidates under investigation have also shown promise.