Good Day BIO: House passes user fee reauthorization; Senate's up next

The House passed FDA user fee reauthorization yesterday, which will help fund FDA research to bring more breakthroughs to patients. We have details and what’s next in the Senate. And with a soil shortage looming, a study finds regenerative farming can boost soil health and food nutrition. Plus, nominations are open for BIO’s George Washington Carver and Rosalind Franklin Awards – details below. (915 words, 4 minutes, 34 seconds)

House passes user fee reauthorization; Senate's up next

The House passed its bill reauthorizing the FDA user fee agreements (among other things), and the Senate’s up next—details below.

The news: The House passed H.R.7667, the Food and Drug Amendments Act, by a vote of 392-28. The legislation reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act  (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). 

What they're saying: During the floor debate, Energy & Commerce Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris-Rodgers (R-WA) and Health Subcommittee Ranking Member Brett Guthrie (R-KY) expressed appreciation for the strong bipartisan effort to develop the package.

Why it matters: “Importantly, these fees not only permit the FDA to carry out drug or device application reviews, but they also represent significant percentages of the FDA’s total operating budget without requiring significant taxpayer spending,” said Rep. Brett Guthrie (R-KY).

FDA user fees yield “significant returns on investment,” he continued: “For example, in 2021 alone, 38 of 50 of the world’s novel drugs were first approved in the United States. This was made possible by the Food and Drug Administration Amendments of 2017.”

The next steps: The Senate Health, Education, Labor and Pensions (HELP) Committee is scheduled to mark up its version next Tuesday, June 14 (rescheduled from this week), with a floor vote expected in July. Meanwhile, the House and Senate will conference the bills with the goal of final passage before September 30 to ensure timely reauthorization of the user fee programs.

Throwback Thursday: BIO's Chief Scientific Officer Dr. Cartier Esham testified before the House Energy & Commerce Health Subcommittee in March on the importance of the legislation.

More Health Care News:

Moderna: Omicron-containing bivalent booster candidate demonstrates superior antibody response against Omicron
“Looking at these data alongside the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a Fall 2022 booster. We are submitting our preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer,” said Moderna CEO Stéphane Bancel.

National Psoriasis Foundation: NPF selects Leah M. Howard as President and CEO
“Howard has been with NPF for 10 years, serving recently as the Chief Operating Officer before stepping into the Interim President and CEO role on January 1, 2022. She has more than 20 years of experience working with voluntary health care organizations.”

Delaware Business Times (Opinion): People, innovation are driving our life science industry
Delaware is home to a “vibrant, dynamic bioscience community,” accounting for more than 11,000 people employed and $2 billion in GDP with payrolls of at least $230 million, writes Michael Fleming, President of the Delaware Bioscience Association.

Healthy soil, healthy people

A study finds regenerative farming is not only good for soil and crops, but also makes food more nutritious—and there’s a role for biotechnology.

The key finding: “regenerative soil-building farming practices can enhance the nutritional profile of conventionally grown plant and animal foods,” says a recent study led by the University of Washington's David Montgomery.

What’s regenerative farming? It’s things like using cover crops, crop rotation, and low-till or no-till farming—techniques developed by one of our favorite scientists George Washington Carver. These techniques can regenerate “healthier soil with more carbon,” explains Mongabay, reporting on the study.

Digging deeper: “Food grown on the regenerative farms, they found, contained, on average, more magnesium, calcium, potassium and zinc; more vitamins (including B1, B12, C, E and K), and more phytochemicals. They were also lower in elements that can be detrimental to human health, including sodium, cadmium, and nickel,” says Mongabay. 

There’s a direct link between soil health and human health: “Most notably, soil health appears to influence phytochemical levels in crops, indicating that regenerative farming systems can enhance dietary levels of compounds known to reduce risk of various chronic diseases,” conclude the study authors.

Biotech can enhance this process. “Researchers at the Salk Institute of Biological Studies are using genetic engineering to develop plants with bigger, deeper roots which will stay in the ground after the crop is harvested,” explained BIO’s Connor McKoy. “Over time, these roots will break down slowly, helping to replenish the soil with carbon.”

The challenge now? We’re facing a soil shortage, because soil is a finite resource and we’re losing a lot of it due to erosion, the UN has warned—all the more reason to advance technologies to boost soil health and productivity.

Biotech helps with that too. Herbicide-tolerant crops developed through biotechnology facilitate expansion of conservation tillage, especially no-till. Conservation tillage reduces loss of topsoil while enhancing wildlife habitat. Studies (like this one) have shown tandem increases in farmers’ adoption of biotech traits and conservation tillage.

Do you know the next George Washington Carver—or Rosalind Franklin?Nominations are now open for BIO’s prestigious awards honoring biotech game-changers: the George Washington Carver Award, recognizing an individual who has advanced biotech innovation to make supply chains greener, and the Rosalind Franklin Award, recognizing a pioneering woman in agricultural and environmental biotechnology. Nominations are open through June 24 and the winners will be announced at BIO IMPACT in Omaha in September.

President Biden’s Thursday: He’s at the Summit of the Americas in Los Angeles, where he’ll meet with counterparts from Canada, Brazil, and Caribbean nations. Meanwhile, Biden nominated Doug McKalip, currently a senior advisor to Agriculture Secretary Tom Vilsack, to serve as Chief Agricultural Negotiator at USTR. 

What’s Happening on Capitol Hill: Farm Bill hearings are underway this week, with the House Agriculture Committee looking at commodities and crop insurance today. The Senate Agriculture, Nutrition, and Forestry Committee will hold a hearing on agricultural trade. Meanwhile, the House passed a gun reform package yesterday, though it’s “unlikely to move in the Senate,” per CNN.