Good Day BIO: Congress talks TRIPS, pandemic preparedness, and animal feed

Members of Congress questioned Health and Human Services (HHS) Secretary Xavier Becerra this week on the impact a proposed IP waiver and emergency funds could have on pandemic preparedness. 

HHS Secretary Xavier Becerra made the rounds on Capitol Hill this week, testifying on the agency’s FY22 budget before House Ways & Means on Tuesday, Senate Appropriations on Wednesday, and Senate Finance on Thursday.  

The hearings were mostly partisan—with Democrats praising the administration’s budget proposal and Republicans focusing on economic recovery, the border crisis, and the Medicare trust fund’s solvency, among other concerns. 

Pandemic preparedness was a focus, with notable exchanges on the proposed waiver of COVID-19 vaccine patents and how to respond more quickly next time. 

A waiver of the WTO's TRIPS protections would take years to have an impact on foreign vaccine production while harming domestic vaccine producers, said Rep. Devin Nunes (R-CA). “To be prepared for the next pandemic, we must have robust manufacturing of pharmaceuticals,” he added—watch the exchange. Rep. Nunes introduced a bill this week that would prevent USTR from negotiating a waiver without congressional consultation and analysis of national security implications.

Becerra promised a TRIPS waiver would not be approved unless the administration could negotiate an arrangement that protects domestic vaccine production.  

Read: Why we can and must share vaccines with the globe 

What about the next pandemic?Sen. Brian Schatz (D-HI) asked about the Public Health Emergency Fund; he co-sponsored a bill to make the fund permanent. “The idea here is to establish a reserve fund so that you don’t have to come back to Congress in order to respond to a public health emergency,” he said. Becerra voiced strong support, joking, “Senator, I think I have to hire you!” 

Drug pricing was covered, too. Sen. Finance Chair Chuck Grassley (R-IA) asked if the administration would support the committee’s bipartisan drug pricing proposal, which is an alternative to H.R. 3. Secretary Becerra did not make specific commitments other than to work closely with the committee to get something done on drug pricing.

More Health Care News: 

CNN: FDA's vaccine advisers debate urgency of vaccinating kids against coronavirus
“While a few advisers said it's too soon to rush the use of vaccines in children because kids are at such low risk from the virus, most argued that it's important to have authorizations on hand should there be a resurgence of the virus in the fall and winter.” 

STAT News: NIH releases a plan to confront structural racism. Critics say it’s not enough
The plan is “intended to eliminate a big gap in grants awarded to white and minority scientists and boost funding for research on health disparities…[I]t would also expand a program to recruit, mentor, and retain researchers from underrepresented racial and ethnic groups, and appoint diversity and inclusion officers at each of its 27 institutes and centers.”

There was bipartisan agreement yesterday on the need to speed up the approval process for new animal feed ingredients—which could lead to fewer belching cows and thus lower emissions.

Natural enteric fermentation in a cow’s stomach causes them to belch methane—making cattle the source of one-third of this high-impact GHG in the U.S., according to the EPA.

Biotechnology has been developing solutions—like feed additives that reduce methane in cattle belches or enzymes that enhance the digestibility of energy, protein, and phosphorus in livestock. BIO has promoted uptake of them, in comments to the USDA on tackling climate change and in policy recommendations we support as a member of the Food and Agriculture Climate Alliance. 

Read: Biotech Solutions for Climate Report 

The challenge: the U.S. Food and Drug Administration (FDA) treats these additives as “drugs”—so approval can take 3-5 years. 

And FDA has been lagging in approving them, Senators agreed during yesterday’s Senate Appropriations hearing on the FDA’s FY22 budget.

“The livestock industry is looking to offer solutions in meeting the challenges related to climate, however, the current FDA policy interpretation regulates certain feed ingredients, which could reduce GHG emissions and benefit the environment, as animal drugs instead of feed ingredients,” Sen. Jerry Moran (R-KS) told Acting Commissioner Dr. Janet Woodcock. “[T]he Center for Veterinary Medicine and Policy Manual dictates these decisions, and it has not been updated since 1998.” 

This approach has prevented the adoption of a technology to achieve Biden’s ambitious climate goals and hurts America’s competitiveness, added Chair Tammy Baldwin (D-WI): “FDA limits the definition of feed additives to products that affect the nutrition of the animal. Environmental benefits are not considered. Europe has adopted a regulatory framework that considers any environmental benefits of feed additives, and New Zealand is poised to do the same thing. With other countries ahead of us by 3-5 years on this issue, U.S. farmers and ranchers could be materially disadvantaged.” 

Dr. Woodcock promised to continue working with the industry and Congress on the issue. 

P.S. You can hear from Dr. Woodock—and many more policymakers and experts—during BIO Digital! Networking is already underway with the Innovation Stage, and educational content begins Monday. Get the details and register now.

More Agriculture and Environment News:

The New York Times: Eighty years later, Biden and Johnson revise the Atlantic Charter for a new era
“Where the original charter contemplated the ‘final destruction of the Nazi tyranny’ and called for freedom to ‘traverse the high seas and oceans without hindrance,’ the new version focused on the ‘climate crisis’ and the need to ‘protect biodiversity.’ It is sprinkled with references to ‘emerging technologies,’ ‘cyberspace’ and ‘sustainable global development.’”

President Biden’s Friday: Attending the G7 Summit in the UK. To catch you up, G7 leaders pledged to donate 1 billion COVID vaccine doses to the world, while the UK Environment Secretary welcomed the return of the U.S. as a leader in climate efforts. 

What’s Happening on Capitol Hill: A House subcommittee holds a hearing on free and fair access to polling places, though broad congressional action voting rights seems unlikely for now. The Select Committee on the Climate Crisis discusses how to build climate-resilient communities.