The State of Metabolic Formula Access in the U.S., Summer 2022

July 18, 2022 marked exactly 5 months since Abbott issued a voluntary recall for several formulas manufactured at its Sturgis, Michigan facility. Although no metabolic formulas were directly involved, the recall and subsequent plant closures continue to massively affect our community. This update is designed to provide insight into the current state of metabolic formula supply in the U.S., direct those in need to valuable resources, and provide tools for advocating for yourself and the community on the formula-shortage issues, which highlight the need to pass the Medical Nutrition Equity Act (MNEA).  All of the updates below underscore a very important message: Supply is not the Same as Access. Even after we recover from the current formula crisis, our community faces multiple barriers to a steady, safe, and affordable supply of the medical formula that we rely on to survive. 

Details follow. Important links include:

This past March a coalition of metabolic-disorder support organizations joined together to establish, a resource for updates on the Abbott situation, which soon caused shortages of other metabolic formulas, as individuals transitioned from Abbott to other brands. This site remains a key resource, and you can see recent updates from Nutricia, Abbott, Vitaflo, and Cambrooke regarding their currently available supply, and find contact information for each company’s patient assistance program. 

RAISING AWARENESS & MAKING A DIFFERENCE also hosts a press page that highlights the activism of so many in our community raising awareness that the current crisis is not just about “baby formula,” and that many in our community rely on these formulas as their primary and life-long medical treatment. The silver lining of this crisis is this awareness: the entire country now understands the life-sustaining value of formula, and this has already benefited our efforts to pass the Medical Nutrition Equity Act, which would require all insurance programs — private, public, exchange-bought and self-funded — to cover medical food and low-protein modified foods for those with PKU, similar inherited metabolic disorders, and specific GI and allergenic conditions.  

Abbott’s Sturgis facility quietly reopened on July 1, and began production of Elecare. Metabolic formulas are next in line, but manufacturing has not yet begun; once it does, it will take eight weeks for newly-manufactured formula to start making its way to customers. (Abbott continues to release formula manufactured before March 2022 free of charge, on a case-by-case basis; contact your clinic to request). Even as other metabolic formula suppliers begin to re-establish a steady supply chain, we’ve faced an additional challenge: Coram/CVS Speciality Infusion Services, a major DME formula provider,  in June announced that it would no longer distribute more than 50 metabolic products from 4 manufacturers. This decision was based on the economics of formula reimbursement, an issue that will persist even after we pass the Medical Nutrition Equity Act. Individuals who previously used Coram for one of the formulas on the discontinuation list should contact their formula manufacturer who will help them find a new DME to provide their formula. 

This crisis has a silver lining: Despite the struggles, the worldwide awareness of the essential nature of formula created an opportunity for PKU and other metabolic disorders to underscore the need to for access to medical nutrition. 

  • The MNEA now has 94 co-sponsors in the House, and 21 in the Senate, and we are actively working with the Patients & Providers for Medical Nutrition Equity to schedule hearings on the bill under the committees of jurisdiction, a vital step towards passing the bill. Even as the end of this legislative session approaches, there’s a chance for passage. Our current focus is on gaining more Republican co-sponsors. You can find your legislators and ask them to support the bill here. 
  • PKU advocates and community members have made their voices heard: in Congressional hearings, in major print media and on national news and radio; the message has been clear: access medical treatment for PKU and similar disorders cannot be denied. 
  • PKU and other metabolic-disorder leaders continue to meet regularly with officials from the FDA, the Department of Health and Human Services, and the Centers for Medicare and Medicaid to demand equitable treatment, and they are listening to our needs.
  • Media continues to report on the formula crisis and this gives all of us in the community an opportunity to make our case: local media is always looking for stories, and we’ve provided talking points here. You can also reach out to [email protected] with any questions. 
  • We are actively working to add the Medical Nutrition Equity Act to the agenda of the upcoming White House Conference on Hunger, Nutrition, and Health, and to urge the administration to reconsider the January 2022 decision that confirmed that there was no national responsibility to cover metabolic formula for individuals on Medicare. Although the official deadline for submitting comments to the White House has passed, their web site is still accepting entries. You can find directions for sharing your medical foods story here.
  • Lastly, the August recess is a great time to talk with your elected officials about the impact of the formula crisis on our community and the need for the MNEA.  Please join us for online advocacy sessions on August 2nd and 11th. These will be recorded so you can watch it any time, but you’ll be able to ask questions and engage with other advocates if you join live!