FOI release

Subcutaneous Hormone Implant Therapy - Availability of Implants/Pellets

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2025/00095

Received 4 February 2025

Published 25 April 2025

Request

This is a follow up request to my previous freedom of information request (ref: FOI2024/0008) concerning your review into the supply of Estra 25mg and 50mg pellets and testo-100 pellets in the UK. In your response to my previous request you confirmed that: "Considering this may be the only suitable treatment option for some patients and the absence of significant safety signals so far, the MHRA has decided to allow supply to resume following a preliminary analysis of available evidence, and while our more in-depth review continues". However, I am informed by the importer (Smartway Pharmaceuticals Ltd) that they have again been instructed to stop supplying these pellets. Please could you provide the following information concerning this decision: 1. When was the current halt on supply of the implants instituted? 2. Is this now a permanent cessation of supply? 3. If the MHRA review of these pellets has now been concluded please confirm its conclusions and provide a copy of any written report outlining these. 4. If the review is still undergoing: (i) why has the importer been instructed to halt supply now? (ii) are there any concerns for patient safety? (iii) when is it expected to conclude? 5. What consultation has been undertaken with prescribers responsible for patients currently reliant on these implants both concerning the review generally, and more specifically concerning the current half of supply. 6. Please provide copies of any communications provided to, or received from, such prescribers by MHRA. 7. Please provide copies of any communication with the US Food and Drug Administration with whom you were engaging concerning the manufacturer of the pellets.

Response

see attached

Documents

• FOI2025_00095 redacted for publication.pdf (122.2 KB)

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