News: A dangerous shortage of specialty formulas

Monday, May 9, 2022

A dangerous shortage of specialty formulas

May 09, 2022

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By Helena Bottemiller Evich

Presented by

With help from Meredith Lee and Hannah Farrow

QUICK FIX

— Three months into the shutdown of a major Abbott Nutrition plant, there's now a dangerous shortage of specialty formulas that keep many children and adults alive.

— Deputy Agriculture Secretary Jewel Bronaugh weighs in on President Joe Biden's proposal to boost U.S. crop production amid fear of global food shortages stemming from Russia's war in Ukraine.

— First in MA: Republican senators are pressing the administration to include specific agricultural trade commitments in a much-anticipated economic framework meant to counter China, ahead of Biden's summit with Southeast Asian leaders in D.C. this week.

IT'S MONDAY, MAY 9. Welcome to Morning Ag, where your host hopes you all had a nice Mother's Day weekend! I got some much-needed uninterrupted sleep, which is the greatest gift. Have a tip? Get in touch hbottemiller@politico.com or @hbottemiller and follow the team at @Morning_Ag.

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Driving The Day

A DANGEROUS SHORTAGE: We're nearly three months into the Abbott Nutrition formula saga, and the plot twists and tragic turns keep coming. First, we learned that the first infant was hospitalized in September — five months before the recall. Then, we found out FDA's inspectors had been in the plant that very week and apparently missed many of the food safety issues that were identified months later.

More recently, your host broke the news that a whistleblower had warned top FDA officials about alleged food safety violations in the plant months before the reported deaths and the recall.

Now, we're seeing an urgent and potentially life-threatening shortage of specialty formulas that are used by thousands of people with unique medical needs, per my latest.

A major supplier: The Abbott plant in Sturgis, Mich., was not only one of the biggest suppliers of infant formula nationally, but it was also the major supplier of several lesser-known specialty formulas that offer a lifeline for thousands of people with rare medical conditions, including metabolic, allergic and gastrointestinal disorders, which can make eating regular foods dangerous or even impossible.

Policy Qs: The situation has rattled parents and medical professionals and raised questions about whether the federal government should do more to ensure critical, life-sustaining supply chains don't break down. This one Sturgis plant manufactured something like 75 percent of all amino acid formulas in the U.S., one parent told us. (Abbott declined to comment on market share or production statistics).

An FDA ask: In a recent budget document, FDA asked Congress to consider giving the agency new authorities to help prevent this type of situation from happening in the future. The agency noted that "no law requires manufacturers of infant formulas or essential medical foods to notify FDA when they become aware of a circumstance that could lead to a shortage of these products."

The agency would like to see a requirement that companies notify the agency if there are anticipated interruptions.

Thought bubble: Would this authority have helped here? Anyone have an idea? Let me know: hbottemiller@politico.com.

PARENTS, CAREGIVERS ARE PANICKING: Parents and caregivers for individuals with special needs are understandably freaking out about their inability to get more of these formulas. A coalition of patient groups for those with a variety of metabolic disorders has been collecting stories from families. They are heartbreaking.

"I am fearful my child's life will be at risk if this Abbott/FDA situation isn't resolved quickly," one parent from California wrote about their 9-year-old son. "Having to balance my emotions on this issue while also maintaining my composure in front of my child is exhausting."

"I am a wife & mother," wrote a 46 year old PKU patient in Oregon , who said she has run out of her prescribed formula. "I am a tax paying citizen and a vital member of my community. However, right now I am exhausted, I'm having almost constant migraine headaches. I am having memory issues. I can become more easily overwhelmed and emotionally fragile. I am malnourished!"

As for the agency: The FDA is aware of the shortages. It publicly announced April 29 that the agency had told Abbott that it "has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas ... on a case-by-case basis."

Product going out on a limited basis: Abbott, for its part, is currently working to release some formula products if health care providers request it. "We opened a special phone line on Friday to field requests from patients for the metabolic nutrition formulas," the spokesperson said last week. The company said it had received dozens of inquiries so far. "We understand that every patient who relies on these important products has critical needs and we are working diligently to provide product as needed."

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

USDA NO. 2 BACKS BIDEN'S CROP SUBSIDY PROPOSAL: MA caught up with Bronaugh and asked about the president's proposal to boost crop production amid the Russian assault on Ukraine, which has caused major disruption to global food supplies.

The U.S. crop subsidy plan is part of Biden's funding request for Ukraine aid, and it includes $500 million in additional federal subsidies for farmers who plant wheat, rice and oilseeds like soybeans, sunflowers and canola.

As we've reported, some agricultural economists have questioned why the administration would try to boost subsidies for crops, especially soybeans, when prices are already so high. Agriculture Secretary Tom Vilsack tweeted praise for the plan this weekend, but he hasn't commented on the merits of the proposal in detail. A USDA spokesperson says the department was involved in designing the programs.

Bronaugh weighs in: Asked about some of the criticism of the subsidies and why she thought the funding was necessary at this point, Bronaugh stressed USDA wants to "support our farmers and ranchers in being productive" amid "concern[s] about food availability."

"To be able to increase the availability of soybeans and wheat in our major commodities, both here in the United States and all over the world, is going to be critical not only from a nutrition security standpoint, but also from an ability to support our producers here in the United States," Bronaugh said.

Since Russia's invasion of Ukraine, Vilsack and other Biden officials have consistently told reporters and ag groups that the full food supply fallout in Ukraine is still unclear. Vilsack in particular has questioned attempts at government intervention as a response, especially requests to allow farmers to plant crops on land currently enrolled in federal conservation programs, arguing U.S. farmers would respond on their own to high prices and help fill global supply gaps without requiring much, if any, federal intervention.

Asked why crops like soybeans would require subsidies into next year, Bronaugh echoed an argument from several other senior USDA officials: that prices could dip in the next year — even though ag economists expect prices to remain high through 2023.

"We always want them to be able to, through their prices, to be able to survive in terms of our major commodities," Bronaugh said. "But the reality of the history of so many years [is that] they have needed more support. And so we as necessary will continue to support them, because that's what they're going to need to be sustainable."

By the numbers: Under the Biden administration's proposal, $100 million would go toward providing a $10-per-acre payment to farmers who plant a soybean crop after a winter wheat crop in 2023. Another $400 million would fund a two-year increase in loan rates for U.S. producers to encourage them to grow more select food commodities, including wheat, rice and oilseeds like soybeans, sunflowers and canola.

A CALL TO EXTEND PANDEMIC-ERA FOOD BENEFITS: The government's expansion of several policies during the pandemic likely helped mitigate an increase in food insecurity nationwide — and those temporary measures should be extended until the next farm bill (which includes federal nutrition programs) is complete, a group of researchers wrote in Health Affairs.

What's going on: Many anti-hunger efforts, from SNAP to school meal programs, increased their benefits and expanded access to more families and students during the pandemic. Many of those expansions are set to end soon, despite new coronavirus variants continuing to arise.

There are also "alarming disparities" between Black and Latinx households compared to white and Asian ones when it comes to food insufficiency.

The solution? The researchers suggest letting federal nutrition assistance programs remain more accessible and increasing benefits to meet actual food needs of households until the 2023 farm bill is enacted. Doing so "will provide stability until broader discussions can occur around which changes should be made permanent."

"The association of Covid-19 morbidity and mortality with chronic conditions such as diabetes and obesity heightened … the role that good nutrition plays in preventing and managing them," the researchers wrote. "Now is the time to ensure that households experiencing food insecurity are not left out of the recovery."

A message from The Interrupt:

Trade Corner

FIRST IN MA: GOP TURNS UP INDO-PACIFIC TRADE PRESSURE: Leaders from Southeast Asia will fly into Washington for a postponed U.S.-ASEAN summit starting Thursday. No doubt there will be talk of Biden's forthcoming Indo-Pacific Economic Framework, a multilateral partnership that's meant to counter China but isn't a full-blown trade deal. Pro Trade's Steven Overly has reported on the skepticism about the effort from agricultural and other trade groups.

GOP pressure: Ahead of the meetings, nearly two-dozen Senate Republicans led by Minority Whip John Thune (S.D.) are pressing the Biden administration to "include market access and enforceable commitments" as part of the Indo-Pacific framework.

In a letter to Vilsack and U.S. Trade Representative Katherine Tai, the senators argue "[t]he failure to include such commitments puts American exporters, including agricultural producers, at a competitive disadvantage in the global market."

Biden's senior ag and trade officials have publicly and privately pushed back on GOP calls for inking new free trade agreements. They're also quick to remind us that they're still pressing China to comply with the Trump administration's "Phase One" trade deal, which led to an immensely costly tariff war between the two major trading partners.

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Row Crops

— The Biden administration is announcing today a new push to lower the cost of high-speed internet for millions of American families, including rural communities that often lack online access. The effort is part of the bipartisan infrastructure law , with the administration now securing commitments from 20 internet providers to either increase speeds or cut prices.

— U.S. agricultural equipment maker AGCO announced it was the victim of a ransomware attack, Reuters reports. The Georgia-based company said it expects operations at some facilities to be affected for "several days and potentially longer."

— Black morel mushrooms for the first time have been cultivated indoors in Denmark, per Good News Network. "The brains behind the breakthrough are a pair of biologists and identical twins: Jacob and Karsten Kirk, who first took up the project in 1986 when they looked to continue improving on an existing American patent for cultivating morels."

— Bird flu is killing an alarming number of bald eagles and other wild birds, according to the AP. Many sick birds are arriving at rehabilitation centers unable to fly. U.S. producers have culled some 37 million chickens and turkeys since the outbreak began in February.

A message from The Interrupt:

Obesity is not a "willpower thing." Obesity is not your fault. Obesity is a disease.

Americans lose $1.7 trillion fighting it annually. And it kills 2.8 million people around the world every year.

We have to stop blaming people with obesity and start exploring a spectrum of solutions that actually work. It's time to work across sectors and industries to meet this challenge.

It's time to focus on what individuals need to secure better health. It's time to interrupt the conversation and confront obesity together. Learn more.

THAT'S ALL FOR MA! Drop us a line: hbottemiller@politico.com; meredithlee@politico.com and ecadei@politico.com .