Policy recommendations were released by a coalition comprised of the food, agriculture, and biotech industry, including BIO, in anticipation of the Farm Bill's reauthorization this year.

What is the Farm Bill?

The United States Farm Bill is a package of legislation that determines the policies and funding for a variety of programs that relate to agriculture, nutrition, natural resources, rural development, food assistance programs, and conservation in the country. It is the primary piece of legislation regarding agriculture and food policy and is among the most crucial pieces of legislation for our food system, our environment, and the health and nutrition of the communities across the nation. The Farm Bill provides direct support to farmers, a financial safety net, and various nutrition assistance programs for American families and communities. According to the National Sustainable Agriculture Coalition, the Farm Bill “connects the food on our plates, the farmers and ranchers who produce that food, and the natural resources – our soil, air and water – that make growing food possible”. Every five years, the Farm Bill expires and is updated by undergoing a reauthorization phase. During the reauthorization phase, the Farm Bill undergoes changes and updates through an extensive process in which it is proposed, debated on, and passed by Congress, and eventually signed into law by the president. The current Farm Bill, which is known as the Agriculture Improvement Act of 2018, was signed into law in December 2018 and is due to expire in 2023. This Farm Bill is comprised of twelve chapters, or titles: I: Commodities, II: Conservation, III: Trade, IV: Nutrition, V: Credit, VI: Rural Development, VII: Research, Extension, and Related Matters, VIII: Forestry, IX: Energy, X: Horticulture, XI: Crop Insurance, and XII: Miscellaneous.

Farm Bill Renewal & Reauthorization

The reauthorization process of the upcoming 2023 Farm Bill will take place throughout this year. Although no official Farm Bill has been proposed yet, many prominent organizations within the agriculture industry have provided their concerns and recommendations for the new Farm Bill. One of these organizations, the Food and Agriculture Climate Alliance (FACA), along with over eighty of its partners, have released their full set of guidelines of recommendations in February 2023. They are calling for a number of new changes and proposals. Some of their notable recommendations in their thirty-page article are:

• Establish a federal definition for biostimulants and a predictable, science-based and risk-based framework for their assessment.
• Support a robust science-based and risk-based regulatory process for animal and plant biotech facilitating sustainable food production.
• Emphasize climate-smart inputs and processes, including biotech.
• Reauthorize the Research Facilities Act (RFA).
• Provide consistent and comprehensive evaluation mechanisms for climate- smart agriculture practices and processes, including measurement, verification, and data collection.
• Support biotechnology to enhance the efficiency and efficacy of agriculture through improvements in genetics.
• Streamline regulatory approval for crops developed using modern plant breeding technologies.
• Enable technologies, such as gene editing, to improve animal genetics to increase production per animal and reduce herd size and help animals adapt to changing weather.
• Ensure USDA’s Natural Resources Conservation Service incorporates feed/nutrition management to reduce emissions and includes products that inhibit enteric methane.
• Reduce barriers to participation in voluntary, high-quality forest carbon markets.
• Invest in research on carbon sequestration and emissions reduction.

Secure and maintain robust funding for Energy Title programs that support renewable energy and energy efficiency investments in rural America, most importantly, the Rural Energy for America Program (REAP).

What does the Farm Bill say about biological products?

The 2018 Farm Bill does not directly address the use of biologics or biosimilars in its content; however, there are certain aspects of the bill that can have an effect on biologics. In the last title, Title XII: Miscellaneous, the bill mentions conducting technology development, which can “prevent, detect, control, and eradicate diseases and pests in order to protect animal health”. One of the examples of technological development in the bill was veterinary biologics, which can be vaccines or other medications made from living organisms that can improve animal health. These technological advancements in veterinary biologics can bring forth a better understanding of biologics and biosimilar medications as a whole and can encourage more research and development into human biologics. Title VII: Research, Extension, and Related Matters discusses expanding research and supporting innovation. This title can include the technologies that are important in researching and developing biologics and biosimilar medications.

Farm Bill Renewal: What to Expect in 2023

As the new 2023 Farm Bill will likely include more emphasis and acceptance on research and development of more technologies, the rate of which biologics and biosimilar medications are produced will increase. With biologics and biosimilars becoming more popular in recent years, biosimilars are expected to boom from 2023 to 2027. A report from IQVIA states that “with biosimilars seeing increasing acceptance in the U.S. and the scale of spending on medicines facing upcoming biosimilar competition growing, the impact on all stakeholders will be significant”. The article also predicts that in the next five years, there is an expected increase in savings of $181 billion, which is more than four times the savings over the past five years ($40 billion), as newer biosimilar products will launch and existing biosimilar products see continued usage and cost reductions. These changes in research and development in the upcoming 2023 Farm Bill will only help to increase the growing use of biologics and biosimilars for the years to come.

HCP Education - Biologics & Biosimilars

Healthcare providers (HCPs) play a crucial role in the safe and effective use of biologics and biosimilars. As biologics and biosimilars become increasingly prevalent in healthcare, it is essential that HCPs receive proper education and training to make informed decisions about their use. Biologics and biosimilars are complex medications that require specialized knowledge and understanding to administer them safely and appropriately. HCPs need to understand the differences between biologics and biosimilars, including their economic considerations. Proper education and training can ensure that HCPs have the knowledge and skills necessary to provide optimal care for their patients, while also minimizing the risks associated with these medications. HCPs can enroll into the Board Certified Biologics & Biosimilars Specialist (BCBBS) program to become experts in this field and demonstrate their proficiency in ensuring patient safety and improving outcomes with biological products. 

Works Cited:

The 2018 Farm Bill (P.L. 115-334): Summary and Side-by-Side Comparison. Congressional Research Service. https://crsreports.congress.gov/product/pdf/R/R45525. Published February 22, 2019. Accessed March 6, 2023.

Biosimilars in the United States 2023-2027. IQVIA. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027 Published January 31, 2023. Accessed March 6, 2023.

Farm Bill Policy Priorities: Recommendations to the 118th Congress. Food and Agriculture Climate Alliance. https://agclimatealliance.com/files/2023/02/farm-bill-recommendations.pdf. Published February 22, 2023. Accessed March 6, 2023.

The Farm Bill: What Will 2023 Bring? The Council of State Governments. https://www.csg.org/2022/09/07/the-farm-bill-what-will-2023-bring/. Published September 7, 2022. Accessed March 6, 2023.

Friedman S. 2023 Farm Bill: An Opportunity for Food and Farm Security. World Wildlife Fund. https://www.worldwildlife.org/blogs/sustainability-works/posts/2023-farm-bill-an-opportunity-for-food-and-farm-security. Published February 7, 2023. Accessed March 6, 2023.

Maher S. What to Expect from the 2023 Farm Bill. Marketplace. https://www.marketplace.org/2022/12/28/what-to-expect-from-the-2023-farm-bill/. Published December 28, 2022. Accessed March 6, 2023.

Makepeace F. What is the 2023 Farm Bill and What You Need to Know. Kiss the Ground. https://kisstheground.com/regenerate-america/. Published June 28, 2022. Accessed March 6, 2023.

What is the Farm Bill? National Sustainable Agriculture Coalition. https://sustainableagriculture.net/our-work/campaigns/fbcampaign/what-is-the-farm-bill/. Published March 31, 2022. Accessed March 6, 2023.

What Should the Farm Bill Include? Biotechnology Innovation Organization (BIO). https://www.bio.org/gooddaybio-archive/what-should-farm-bill-include. Published February 23, 2023. Accessed March 6, 2023.