Kansas Senator questions FDA regarding national formula shortage

Kansas Senator questions FDA regarding national formula shortage
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TOKEPA, Kan. – National shortages of baby formula lead Kansas congressmen to raise questions with the FDA.

After baby formula that contained bacterial contaminants was sent out across the U.S, some manufacturing companies have been on hold.

When producers say they were ready to begin manufacturing again, lawmakers said the FDA would not give these laboratories the go-ahead.

In response, Kansas Senator Roger Marshal Submitted a letter to the FDA Commissioner.

The letter from Marshal states:

The safety of, and access to, infant formula should be among CFSAN’s highest priorities, as this food is vital for the growth and development of infants. To this end, we write to request a response from FDA on its activities that contributed to the exacerbated infant formula shortages and specific questions in the following paragraphs. It is our responsibility as U.S. Senators to do everything with our authority to hold the FDA accountable and legislate in areas that will enable the agency to meet the expectations of the American people.

In addition to the letter, Senator Marshal says the state intends to submit a bill that would require the FDA to examine formula manufacturing plants in Europe.

Marshal’s letter states furthermore:

Based on the timeline, it is unclear why federal health agencies have not been able to complete this investigation in a more expeditious manner or plan ahead to mitigate this additional supply chain disruption. Therefore we respectfully request your responses to the following questions:

  1. The manufacturing facility in Michigan is segmented where manufacturing designated areas are required to adhere to specific safety and infection control standards. The facility also maintains areas that are administrative and do not directly handle manufacturing or exposure of open products. Please describe the areas in which the FDA has taken samples and how many samples were taken that would empirically validate the results of the investigation. In your explanation, please also include the expected timeline for each task and if CFSAN has met its obligations.
  2. As noted in the paragraph above, the CDC concluded that the samples taken did not match the bacteria in the facility. How does the FDA partner with other agencies at the federal, state, and/or local level to expedite investigations to forestall potential supply chain crises? To what extent do other agencies or organizations advance or hinder a timely investigation?
  3. Why has it taken more than three months to complete the obligations required to finalize a safety inspection?
  4. At what point did the FDA alert the White House of the bacteria and the product recall?
  5. Did the FDA, along with the White House, have a strategic plan in place to mitigate formula shortages? If yes, please provide a brief description, date of implementation, actions the agency has taken, and expected timelines to enable manufacturers to produce, process and deliver food during supply chain disruptions.
  6. Did or has the FDA made any recommendations to the White House about what actions the agency can take to prepare or handle the shortage?
  7. The manufacturing facility in Sturgis, Michigan is the only Abbott plant to produce specialized formula for infants with metabolic disorders. How is the FDA going to work with Abbott and other formula manufacturers to ensure that the special medical needs of infants can be met?
  8. Abbott Nutrition, along with other infant formula manufacturers, have registered domestic and foreign sites to manufacture infant formula for interstate commerce in the U.S. Abbott Nutrition’s facility in Ireland is an FDA-registered facility. It also has several other facilities in the Netherlands, Spain, and France that manufacture infant formula. What steps has FDA taken to increase importation by accrediting more manufacturing facilities overseas?
  9. At what point was the White House made aware that these importation options were available to ease the strain on domestic capacity?
  10. Whose decision was it to ease these requirements on formula from foreign manufacturers?
  11. In White House press briefings, the Press Secretary and others within the Biden Administration appeared to have blamed Abbott Nutrition for the deaths and shortages, despite the fact that the investigation has yet to be concluded. , Did the FDA state to the White House that Abbott Nutrition was responsible for the illnesses or deaths?

Officials Say the FDA is yet to comment on Sen. Marshall’s letter.