340B, food security – and see you at BIF!

We’re heading to San Francisco for the BIO Investor Forum—you can follow the action all week long right here in your inbox and at Bio.News. Meanwhile, we look at how 340B could be improved and how biotech is boosting food security. (813 words, 4 minutes, 3 seconds)

Bio.News at the BIO Investor Forum

This week, we're live at the BIO Investor Forum in San Francisco! We'll be bringing you the highlights right here in your inbox on Wednesday, 10/16, and Thursday, 10/17, including:

• Understanding the current fundraising environment and market outlook
• The latest on neurodegenerative disease, AI, and oncology
• The policy outlook and how it will impact innovation

You can follow our coverage right here and at Bio.News and BIO's LinkedIn and X.

BIO urges rebates in 340B administration

Companies having the option to administrate the 340B program through rebates would provide much-needed transparency, BIO explains in a letter to Carole Johnson, Health Resources and Services Administration (HRSA) Administrator.

What’s 340B? It was designed to allow hospitals, clinics, and their on-site pharmacies in underserved communities to receive discounts from drug manufacturers in order to help provide discounted drugs and other health care services to patients in need. However, hospitals in wealthy areas misuse the system to profit through contract pharmacy arrangements, which grew 4,228% from 2010-2020 and distort the program’s intentions.

Why it matters: “As HRSA’s audits and other federal agency reports confirm, the 340B program has long operated in transgression of its statutory bounds,” says BIO’s letter. “The historical record could not be clearer: To date, the program has lacked a meaningful mechanism to adequately police eligibility.”

A solution: “The 340B statute provides flexibility for a participating manufacturer to give access to the 340B ceiling price in more than one way, including through a rebate,” continues BIO. “Use of 340B rebates would significantly help to mitigate the duplication and diversion risk inherent in the current model.”

The bottom line: “Use of 340B rebates would, among other things, enhance the transparency and integrity of the 340B program and facilitate the effectuation of the interrelated nonduplication provisions of the [Inflation Reduction Act],” says the letter. “BIO strongly supports the use of 340B rebates as an option for manufacturers.”

Read the full letter.

Biotech boosts food security: I am BIO Podcast

As climate change threatens crops and livestock, biotech improvements can help us, explains the latest episode of the I am BIO Podcast.

“The very first biotech potato,” J.R. Simplot’s “Innate” potato, is less likely to bruise. “That reduces waste” as less of the crop is thrown out by retailers and consumers, says David Hirschi of the J.R. Simplot Company.

And: “A variety of strawberry that naturally has a 15- to 20-day shelf life,” explains Hirschi. “We could see that they have this ‘short flower’ gene, but they also have this ‘flower all the time’ gene,” Hirschi continues. Simplot used CRISPR to extend strawberries’ shelf life and flowering time.

Acceligen uses gene editing to produce heat-tolerant Holsteins, says CEO Tad Sonstegard. Semen from these cattle can be exported “to a tropical zone like Nigeria, Kenya, Brazil. And you can breed that animal to a local cow, and you can increase the milk production.”

“The most potential for its impact is going to be in emerging economies,” Sonstegard says. “If we look at what an average animal produces for dairy in sub-Saharan Africa, the yield gap in milk is huge,” with U.S. cows being as much as twelvefold more productive.

“You get more bang for your buck, as far as resources go, in producing animal protein,” Sonstegard says, enhancing food security in lower-income countries.

Listen here or wherever you get your favorite podcasts.

What Else to Know This Week

As Medicare open enrollment nears, 'M3P' and the out-of-pocket cap loom large, explains BIO. The $2,000 out-of-pocket cap and the introduction of the Medicare Prescription Payment Plan, or M3P, will fundamentally alter the way that individuals pay for their medicines in Medicare Part D. Read more in Bio.News.

AMR is ‘more horrific’ than we thought. A September Lancet study found that in the next quarter century, researchers project 169 million deaths associated with antimicrobial resistance and more than 39 million deaths directly from AMR infections. This was a key topic during the Sept. 26 UN General Assembly’s High-Level Meeting on AMR, with UN Under-Secretary General Inger Andersen noting that the study’s findings were “much more horrific than we might have thought.” Read more on Bio.News.

Rep. Randy Feenstra (R-IA) reiterates the need for action on Mexico's corn ban: “We have a responsibility and an obligation to our corn farmers—and every industry that overlaps with the production of corn—to resolve this dispute in a timely fashion and ensure that Mexico’s ban on American corn cannot take effect,” he writes in the Iowa Times-Republican. He and 20 House colleagues sent a letter to U.S. Trade Representative Katherine Tai and U.S. Secretary of Agriculture Tom Vilsack to engage with the newly inaugurated President of Mexico Claudia Sheinbaum over Mexico’s ban on GM corn imports and other trade barriers affecting American businesses—read more on Bio.News.

“Imagine a future where we could predict drug safety and efficacy accurately before clinical trials even begin,” said Renee Wegrzyn, Ph.D., Director of Advanced Research Projects Agency for Health (ARPA-H), which is launching a program to develop more accurate predictive drug safety and efficacy models for Investigational New Drug (IND) candidates. The Hybrid Proposers’ Day will take place on Oct. 29; registration closes Oct. 22 at 12pm ET.

Beltway Report: What's Ahead in Washington

President Biden is planning to sign an executive order directing the Department of Health and Human Services to explore additional actions to lower prescription drug costs, according to the White House.

The House and Senate are in recess.