Bayh-Dole march-in surprise

The White House made a surprise announcement today about using Bayh-Dole march-in rights. A House committee advanced additional PBM reform bills, and a new poll shows that Americans support advancing biotech to address climate change. (526 words, 2 minutes, 37 seconds)

White House says it will allow Bayh-Dole march-in petitions to consider price 

The White House today announced plans to use Bayh-Dole “march-in rights” to step in and license patent rights of drugs “developed with federal funding” to other manufacturers when the price of the drug is deemed too high.

The news: As part of a broader health care announcement covering a number of policy areas, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) today released for public comment its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.”

BIO’s view: Bayh-Dole was created “to facilitate the commercialization of technologies developed from federally funded inventions—not to serve as a backdoor for price controls,” says a letter sent to Health and Human Services Secretary Xavier Becerra, signed by BIO and nearly 100 other academic and private-sector experts and organizations.

What’s next: The 60-day comment period will close on Feb. 6, 2024, after which NIST will review and make publicly available all comments received, before finalizing the guidance. BIO will be analyzing the initial proposal and responding.

Watch: President Biden’s video announcing the decision.

House committee advances additional PBM reforms

In day two of a 44-bill markup, the House Energy & Commerce Committee yesterday advanced 21 pieces of health care legislation, including more bills addressing pharmacy benefit managers (PBMs).

Why it matters: PBMs act as middlemen between drug makers, health plans, and pharmacies, using their market power and opaque practices to profit by driving up drug prices. BIO has been pushing for reform as the appetite for PBM legislation has grown in Congress this year.

The Protecting Patients Against PBM Abuses Act, introduced by Reps. Buddy Carter (R-GA) and Lisa Blunt Rochester (D-DE). Rep. Carter recommended an amendment based on text from the Senate’s Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. This includes “PBM transparency requirements” and regulates “arrangements with pharmacy benefit managers with respect to prescription drug plans and [Medicare Advantage prescription drug] plans.”

The Medicare PBM Accountability Act, introduced by Reps. Greg Landsman (D-OH) and Diana Harshbarger (R-TN), would enhance PBM reporting requirements. 

What they’re saying: Ranking Member Frank Pallone (D-NJ) said the bills passed would ensure PBMs are “truly providing a benefit.”

Another bill to note was the passage of H.R. 5397, the Joe Fiandra Access to Home Infusion Act which would provide Medicare coverage to home infusion drugs that are not self-administered.

What’s next: These bills must go before the full House. They’ll need Senate approval before becoming law.

Ask your Member of Congress to support PBM reform—click here to learn more and send your message today.

Watch: Rep. Lisa Blunt Rochester explains the importance of “bipartisan, bicameral, and…common sense policies” to reform PBMs.

Poll: Americans support biotech as ‘climate tech’

Americans think biotech is essential to addressing climate change, and they want government support for biotech solutions, according to a poll published today.

The key findings: More than half of the respondents think more must be done to address climate change and 66% say policy should prioritize biotech solutions for climate, according to a poll of 4,411 adults conducted by Morning Consult for BIO.

Why it matters: The poll sends a clear message to leaders currently meeting at the COP28 U.N. Climate Change Conference in Dubai that citizens want action, and they want it to include biotech.

How it can help: 78% of respondents think biotech can promote food security, and 75% think it can help with public health challenges caused by climate. Specific objectives named in the poll include:

• Increasing overall food production (54%).
• Producing crops that can resist climate impacts (46%).
• Reducing deforestation (43%).
• Absorbing carbon dioxide (40%). 

Biotech climate solutions include… crops bioengineered to withstand harsh weather, pests, and disease; biobased fuels and materials; produce engineered to last longer and reduce waste; alternatives to synthetic fertilizers; feed additives to reduce methane emissions; and plant-based proteins produced with lower greenhouse gas emissions.

BIO’s view: “When you look at the many ways in which biotech companies are rising to the challenge of reducing and mitigating climate impacts, such as developing crop traits and plant-based materials to replace fossil resources, there is no question that biotech is ‘climate tech,’” says Beth Ellikidis, VP for Agriculture and Environment at BIO.

Read more in Bio.News.

President Biden’s Thursday: No official business scheduled.

What’s Happening on Capitol Hill: No major hearings scheduled today.