On December 11, 2024, the FDA announced the following on its domperidone page:
“Update: FDA was informed in late 2022 that the
current supplier of domperidone was exiting the business due to transfer of
ownership of the product to another company and, as such, will no longer supply
domperidone tablets for treatment use under expanded access. Efforts made
in the interim to identify an alternative source have been unsuccessful. The
current supply will be exhausted as early as the first or second quarter of
2025, at which time this program will no longer be able to supply domperidone
for treatment use under your expanded access IND. FDA understands that this may
pose challenges as you continue to care for your patient(s). We are making you
aware of this development now so that you may begin to explore other treatment
strategies.”
As a gastroparesis patient and advocate who has used and benefitted from the effects of domperidone for many years and has witnessed the advantages of this medication in the numerous online support groups I manage, this is alarming news. I seek clarification and answers for my community.
I initially contacted the FDA on December 13, 2024, to try to gain a better understanding of the situation and was denied additional information. FDA staff, though congenial, would not specify whether the “supplier” in question was Dougherty’s Pharmacy (the only legal distributor of domperidone in the U.S. or Janssen, the manufacturer) and would not provide information as to the steps they had taken to “identify” an “alternative source.” FDA staff indicated that the statement on the website would be the only information released to the public. I expressed my deep concerns about the impact this would have on the gastroparesis community – as domperidone is a life-saving medication for some community members – and the narrow dissemination of the notice, as patients rarely, if ever, visit the FDA domperidone page. The FDA representative directed me to “spread the word” and consider contacting my congressional representatives (which I will gladly do).
Upon the denial of additional details from the FDA, I contacted Dougherty’s Pharmacy directly and was informed by the pharmacy manager that they were unaware of the cessation of the FDA Expanded Access Program for domperidone. The manager consulted the FDA website for confirmation while I was speaking with him and seemed stunned by the notice. He instructed that he would speak with his contact at the FDA and call me back with any new information he was at liberty to share. He contacted me the following day, after speaking with the FDA, and told me that the program seemed to be ending but he did not know the details. He further stated that Dougherty’s was willing to continue to supply domperidone and would even compound the medication if permitted by the FDA because of domperidone’s life-saving importance to gastroparesis patients.
After speaking with the pharmacy manager the second time, I contacted the medical science department at Janssen and spoke with a representative who, though not familiar with Motilium/domperidone, researched the product status in the system and noted that the current status of domperidone had not changed; the system indicated that Janssen was still manufacturing and providing domperidone to the FDA Expanded Access Program and there was no indication in the system that this would cease.
Since the answers I received from Dougherty’s and Janssen did not make sense in the light of the FDA notice, I contacted the FDA again on January 7, 2025. Again, I was denied details and was told that the program would end. The Patient Affairs representative I spoke with wished to be helpful but did not have adequate information to supply. She offered to research the issue and contact me once she had done so. She contacted me the following day but could tell me no more than the update on the FDA site was the correct and only information that the public would currently be supplied. She further encouraged me to detail the issues in a follow-up message to the FDA.
I seek answers
to the following questions:
· If Dougherty’s or Janssen is the “supplier” mentioned, why was neither party aware of the cessation of the program?
· Since the FDA has known about the supply issues since 2022, why is the gastroparesis community only now, more than 2 years later, being informed of the crisis? Does the FDA consider this adequate notice for doctors and patients who will struggle to identify new treatment strategies? What additional steps have been/will be taken to inform doctors and patients of the program cessation?
· What steps have been taken since 2022 to identify an alternate supplier? Who has already been contacted and who is on the list of future contacts? Why are there no other alternatives for obtaining domperidone if another supplier cannot be identified?
· What “other treatment strategies” does the FDA deem available to the gastroparesis community since only one medication (Reglan/Gimoti) has been approved by the FDA for use in gastroparesis patients (and that medication comes with a black box warning)? (It should be noted as well that most patients prescribed domperidone have already tried and been failed by Metoclopramide.)
The FDA must recognize the deeply negative impact the
cessation of the Expanded Access Program for domperidone will have on the
gastroparesis community. Make no
mistake, this program is the difference between survival and starvation for
many people in this community; needless suffering and deaths will result. I seek information and solutions on behalf of
my community members and will not rest until I have them.
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