FOI release
Request for information - Ref: FOI2026/00111
Some or all of the information requested may not have been provided because we determined that the request was vexatious.
Case reference FOI2026/00246
Received 4 March 2026
Published 6 May 2026
Request
Thank you for your response dated 3 March 2026 and for the guidance regarding the cost limit under Section 12. To assist the MHRA in providing a response within the appropriate limit, I am refining the scope of my request. Instead of all psychiatric disorders, I request that the MHRA provides the requested information for one of the following two representative SSRI medications. Please choose the one that is most easily accessible within your records to satisfy the cost limit: • Option A: Fluoxetine (Prozac) – representing the foundational SSRI approval. • Option B: Sertraline (Lustral/Zoloft) – representing a widely prescribed modern SSRI. For the chosen medication, please provide clear YES/NO answers and specific document references for the following: 1. Measurable Biological Cause: Does the MHRA possess any documentation (e.g., from the initial Marketing Authorisation or subsequent reviews) that identifies a specific, measurable biological abnormality or biomarker in patients that the medication is intended to correct? 2. Biological Normalisation: Does the MHRA possess documentation demonstrating that the therapeutic effect of the medication is clinically proven to "normalise" or "balance" a pre-existing and measured neurochemical deficiency (e.g., serotonin levels)? 3. Clinical Thresholds: Does the MHRA possess documents specifying the "normal clinical range" or "threshold values" for serotonin levels used to define the disease state for which the medication is prescribed? 4. Scientific Rationale for Prescription: Does the MHRA possess any document explaining the scientific rationale for why diagnostic biological measurements (e.g., neurotransmitter levels) are not required or performed before the medication is initiated? If the MHRA maintains that this information is only available within specific Public Assessment Reports (PARs), please provide the direct reference or document title for the specific PAR where the scientific evidence for the biological cause/correction is documented for the chosen drug. I look forward to your response within the statutory timeframe.
Response
See attached
Documents
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