FDA's new animal biotech agenda

Starting a new week with FDA’s plans to modernize animal biotech regulations and how we can improve Hispanic health outcomes. Plus, learn how you can share this newsletter with your colleagues and friends. (598 words, 2 minutes, 59 seconds)

FDA’s new Animal and Veterinary Innovation Agenda calls for modernizing regulation

The Food and Drug Administration (FDA) on Friday launched a campaign to support innovation in animal biotechnology, veterinary products, and animal feed through greater “regulatory flexibility, predictability, and efficiency.”

What it is: The Animal and Veterinary Innovation Agenda released by FDA’s Center for Veterinary Medicine (CVM) has four objectives:

1. Support technologies and products addressing priority needs.
2. Align regulatory pathways to the modern landscape.
3. Enhance the One Health workforce for the future of innovation.
4. Address gaps in new technologies and emerging health threats.

Why it matters: The agenda supports the development of novel feed additives and cell-cultured ingredients, animal biotech products, intentional genomic alterations in animals, and more, the FDA said.

What FDA will do: Reassess and adjust product review processes to align with the current state of innovative technologies; expand the Veterinary Innovation Program; invest in data modernization; reimagine CVM’s science program; and scan for emerging technologies.

“The time is ripe for an innovation agenda,” said CVM Director Tracey Forfa. “Veterinary medicine, animal industries, and food production are at an exciting moment where new technologies hold great promise—while global markets, strife, climate change, and increased disease threats mean our food system and animal industries need to become more creative and resilient.”

Improved health for Hispanic community is a matter of trust

Mistrust of the system is the greatest public health challenge facing the Hispanic community in the United States, an advocate tells Bio.News.

Kicking off Hispanic Heritage Month (Sept. 15-Oct. 15), Julissa Soto, a Mexican-born health advocate and equity consultant, explains how to address inequities in care and improve patient outcomes in Hispanic communities.

Why it matters: Hispanic respondents tell Pew their health outcomes are worse for a number of reasons—from having less access to care and less advanced care to being more likely to hold jobs with health risks and live in communities with environmental problems.

The challenge: We need to overcome “fear, suspicion, mistrust of a public health system that we as immigrants sense is so marginalizing that we don’t utilize it to prevent illness that could be prevented,” says Soto.

The solution: “Public health has to be willing to validate the Latino culture and authentically engage people,” says Soto. “With that, the Latino community can begin to build a culture of health in their communities.”

The bottom line: “With the new diseases on the horizon as well as the possibilities of the old diseases coming back, consider vaccination as an act of love to protect not only your health, but your family’s health. Remember that vaccines save lives,” says Soto.

Read the whole interview.

More Health News: 

Reuters: U.S. Chamber of Commerce urges judge to block Medicare drug pricing program
“[Attorney Jeffrey] Bucholtz argued the program effectively establishes ‘price controls’ that will result in unfair rates that violate the due process clause of the U.S. Constitution’s 5th Amendment. Bucholtz said that far from establishing a real negotiation, the drugmakers either must agree to whatever the government deems to be the ‘maximum fair price’ or face draconian penalties in the form of an excise tax of up to 1,900% of U.S. sales of the drug.” 

President Biden’s Monday: The UN General Assembly kicks off today, and Biden plans to meet this week with foreign leaders, including Brazilian President Luiz Inácio Lula da Silva, Israeli Prime Minister Benjamin Netanyahu, and Ukrainian President Volodymyr Zelensky, AP reports.

What’s Happening on Capitol Hill: House Republicans are working on a continuing resolution to keep the government open past Sept. 30, but the Senate is not likely to approve the plan, The Washington Post reports. We’ll be watching tomorrow’s hearing on pharmacy benefit managers by the House Oversight Committee.