Sen. Marshall, Colleagues to FDA Commissioner: Quit Ignoring Baby Formula Applications

(Washington, D.C., September 21, 2022) – U.S. Senator Roger Marshall, M.D. – an OBGYN who delivered more than 5,000 babies – along with U.S. Senators Shelley Moore Capito (WV) and John Boozman, O.D. (AR) led 10 of their Senate Republican colleagues in a letter to the U.S. Food and Drug Administration (FDA) regarding the agency’s ongoing strategy to replenish the supply of baby formula across the country.

In particular, the Senators expressed their concerns that the FDA has not approved enough formula applications to restore national baby formula supplies or prevent another shortage from occurring. They wrote in part,

“Despite the numerous flexibilities and resources provided by Congress and temporary import flexibilities outlined in your letter, the infant formula crisis persists nationwide… American families need permanent long-term solutions, and that includes increasing capacity and competition in the U.S. market…Given the delicate nature of the infant formula supply chain, it’s become even more apparent that we need to diversify our commercial capacity by providing other industry manufacturers the opportunity to compete… Under the enforcement discretion authorized by President Biden’s May Executive Orders to address the formula crisis, the FDA approved only 23 infant formula products, or base powder, from 10 unique manufacturers out of dozens of ex-U.S. based formula and milk companies that have applied for short-term FDA approval to provide infant formula to the U.S. marketplace… The last application granted by FDA for enforcement discretion was August 10, over a month ago… it is unclear why the Center for Food Safety and Applied Nutrition has chosen to ignore so many applications for more manufacturers to market infant formula products for interstate commerce.

The Senators concluded their letter with questions about the FDA’s approval process for formula applications, how many applications have not been answered and why, and if applications for specialty formulas had been considered, among others.

Joining Senators Marshall, Capito, and Boozman on their letter were Senators John Thune (SD), Thom Tillis (NC), Jerry Moran (KS), Cynthia Lummis (WY), Roger Wicker (MS), Rick Scott (FL), John Barrasso, M.D. (WY), Kevin Cramer (ND), Bill Cassidy, M.D. (LA), and Marsha Blackburn (TN).

You may click HERE or scroll below to read the full letter.

Commissioner Califf:

Thank you for responding to our letter regarding the U.S. Food and Drug Administration’s (FDA) investigation of Abbott Nutrition’s facility and the infant formula shortage crisis. Despite the numerous flexibilities and resources provided by Congress and temporary import flexibilities outlined in your letter, the infant formula crisis persists nationwide.1, 2, 3 Some of the FDA’s flexibilities are set to expire at the end of this month and Operation Fly-Formula, while alleviating some issues, cannot run indefinitely. American families need permanent long-term solutions, and that includes increasing capacity and competition in the U.S. market.

The infant formula market has consolidated over the years due to manufacturing-related issues and consumer demand so any disruption in an oligopoly will undoubtedly lead to supply chain shortages. Over 80 percent of the market is largely comprised of three manufacturers including Abbott Nutrition, Mead Johnson, and Perrigo. Abbott Laboratories lead with 49.5 percent, followed by Mead Johnson at 20.6 percent, and Perrigo with 11.9 percent.4 Abbott Nutrition recently announced it will restart its Similac® infant formula production at its facility in Sturgis, Michigan.5 We understand FDA did not establish or rule out a direct link between the deaths and the formula produced at the plant. But we now know that any disruption from one manufacturer – including one that makes up almost half of the infant formula market – can devastate families and cascade into a whole-of-government approach to resolve. Given the delicate nature of the infant formula supply chain, it’s become even more apparent that we need to diversify our commercial capacity by providing other industry manufacturers the opportunity to compete. This is especially necessary for manufacturers of infant formula products that cannot be reasonably substituted by currently available products.

Despite this significant crisis, to date, under the enforcement discretion authorized by President Biden’s May Executive Orders to address the formula crisis, the FDA approved only 23 infant formula products, or base powder, from 10 unique manufacturers out of dozens of ex-U.S. based formula and milk companies that have applied for short-term FDA approval to provide infant formula to the U.S. marketplace. Of the products approved, 13 were approved for infants who rely on “regular” formula products, and only three are for special nutrition needs. In addition to these products intended for infants who rely on “regular” formula, the agency has approved just 6 specialty products, or bases, from 5 unique manufacturers. The last application granted by FDA for enforcement discretion was August 10, over a month ago.

What’s most concerning is FDA’s decision last month to defer further review of pending applications after taking over a month to respond.6, 7 We understand from several manufacturers that FDA has still not indicated any attempt to review or prioritize increasing domestic production through competition.

Given the above, it is unclear why the Center for Food Safety and Applied Nutrition has chosen to ignore so many applications for more manufacturers to market infant formula products for interstate commerce. Therefore, we respectfully request your responses to the following questions:

1. Over the last several months, how many applications for infant formula products has the FDA received, and what were the committed quantities in these applications?

2. For the 16 products approved, what is the current status of manufacturers’ production capacity and committed quantities?

3. Of the 10 unique manufacturers applications that FDA approved, which manufacturers delivered on committed quantities?

4. For manufacturers the FDA approved, have any of their authorizations been withdrawn? If so, please describe the reason.

5. How many applications are currently pending? Starting from the submission dates, what is the timeline of each application’s status based on FDA’s classification of its stages for approval?

6. Are there applications pending, deferred, or denied that aimed to bring to market specialty infant formula?

7. Has the FDA provided reasonable flexibilities in its communications with applicants?

8. Can you provide a clear explanation as to why no additional applications for regular infant formula have been approved since August?

The FDA has the opportunity to learn from this crisis and ensure this does not happen again. We would appreciate a reply no later than Wednesday, October 5, 2022. Thank you for your attention to this matter and please do not hesitate to reach out to us or our staff should the agency require resources or cooperation from other agencies to fulfill its obligations.

Background:

Last week, Senator Marshall wrote a letter to U.S. Department of Agriculture Secretary Tom Vilsack, U.S. Department of Health and Human Services Secretary Xavier Becerra, FDA Commissioner Califf, and National Economic Council Deputy Director Sameera Fazili demanding answers to the Biden Administration’s ongoing response to the nation’s baby formula shortage that is still wreaking havoc in communities across the U.S. You may click HERE to read the letter.

Earlier this year, Senator Marshall launched a webpage to help struggling Kansans with the baby formula shortage and understand safe infant feeding practices. You may click HERE or on the image below to access the webpage.

In May, President Biden signed the Access to Baby Formula Act, legislation Senator Marshall helped introduced alongside a bipartisan group of senators. The legislation:

• Gives USDA permanent authority to respond in the event of a product recall or supply chain disruptions and provide WIC flexibilities including:
  • Allowing vendors to exchange or substitute authorized supplemental foods;
  • Allowing flexibility so a doctor’s note is not needed to access another brand of formula;
  • Flexibilities on the maximum monthly allowance for infant formula, and;
  • Allowing for additional flexibilities so long as they do not substantially weaken the nutrition quality of the products.
• Gives USDA permanent authority to respond to an emergency or disaster and provide WIC flexibilities as needed.
• Requires baby formula rebate contracts to include a plan to respond to a baby formula recall, including how the manufacturer would prevent shortages of baby formula and require manufacturers to follow these new requirements in the event of a recall.
• Ensures that FDA and USDA have a Memorandum of Understanding so that FDA is increasing communication with USDA. It is key that USDA has access to information so that the Department is prepared to respond to potential shortages within the WIC program.

Additionally in May, Senator Marshall led 21 of his colleagues on a letter demanding answers from the U.S. Food and Drug Administration (FDA) regarding its inadequate investigation into Abbott Nutrition’s Michigan manufacturing facility and failure to mitigate the nationwide baby formula shortage. The senator also asked questions regarding when the White House was made aware of the dire situation and the steps available to limit the harmful impact on families and their newborns.

Finally, in May, questioned FDA Commissioner Robert Califf, M.D. about the baby formula shortage that is wreaking havoc on Kansas families. During the hearing, Senator Marshall read a handful of emails he has received from Kansans struggling to find baby formula. You may click HERE or on the image below to watch Sen. Marshall’s exchange.

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