Heart disease patients and IRA’s misguided incentives

BIO explains why the Inflation Reduction Act (IRA) price controls will lead to fewer cardiovascular treatments, and how we can achieve the government’s “Bold Goals” for the bioeconomy. (482 words, 2 minutes, 24 seconds)

IRA price controls are especially hard on heart treatments, studies show

The Inflation Reduction Act (IRA) is expected to have broad negative impacts on patients, including those with heart disease, given the unique challenges around cardiovascular treatments, explains BIO in Bio.News.

The impact is likely to take two forms:

• Dampen investment in innovation, especially innovation that broadens the use of existing cardiovascular therapies.
• Result in new access barriers and higher costs that fall disproportionately on patients with heart disease. 

The result: fewer cardiovascular treatments.

What the research says:

• According to research coauthored by BIO, cardiovascular disease ranks 14th out of 15 disease areas in the chance of a medicine making it from Phase 1 to FDA approval. Companies take that risk because the need around heart disease is so great.
  
• Cardiovascular clinical trials are not only riskier but also longer and more expensive, according to an Avalere assessment.
• According to a new study from Duke University, 65 cardiovascular or antithrombotic treatments were approved between 1995 and 2001. Of those, 49% of indications and 76% of industry-funded clinical trials were completed after the treatment was first approved.

BIO’s view: Heart disease innovations have had a profound and positive impact, with death rates from cardiovascular disease falling by double-digits between 2009 and 2019. The IRA threatens this success with a series of disincentives that hit heart disease innovation especially hard, which is why Congress must take up bipartisan solutions that would fix flaws in the law and protect patients’ ability to get the cures and treatments they need. 

Read more in Bio.News.

To achieve ‘Bold Goals’ for bioeconomy, follow the science

One year after the Biden administration described the possibilities of a strong bioeconomy, that vision remains achievable—and extremely important for the climate and the U.S. economy.

Catch up: On September 12, 2022, Biden signed an executive order to boost the bioeconomy with a whole-of-government approach. On March 22, 2023 (one year ago), the White House Office of Science and Technology Policy released the Bold Goals for U.S. Biotechnology and Biomanufacturing to explain what these actions should achieve. 

These goals include:

• Replace fossil-fuel-based plastic with biobased and recyclable polymers.
• Reduce methane emissions from agriculture to help cut U.S. greenhouse gas emissions 50% by 2030.
• Produce 30% of U.S. chemical demand via sustainable and cost-effective biomanufacturing within 20 years.
• Manufacture cell-based therapies at scale to expand access and reduce manufacturing costs 10-fold within 20 years.
• Sequence genomes of 1 million microbial species and understand the function of 80% of the newly discovered genes within five years.

These targets are achievable—and government actions could help, says BIO, including:

• Implementing the Bioeconomy Executive Order.
• Facilitating interagency coordination.
• Encouraging government officials to catalyze public-private partnerships to further accelerate gains made by biotechnology.

BIO’s view: “Biotechnology addresses some of society’s greatest challenges. Implementing the administration’s Bold Goals would promote continued innovation and incentivize even more progress in the bioeconomy,” says Beth Ellikidis, BIO's VP for Agriculture & Environment. “We urge action to operationalize those goals.” 

Read more in Bio.News.

President Biden’s Monday: No public events scheduled.

What’s Happening on Capitol Hill: Two weeks of recess begin after a working Saturday to pass a $1.2 trillion spending bill.