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Letter from MHRA (prescribing natural thyroid extract)

Letter from MHRA
June 2004

Dear Ms Turner

ARMOUR THYROID AND PORCINE THYROID EXTRACT FOR THYROID REPLACEMENT THERAPY.

I am responsible for the professional aspects of the importation of unlicensed medicine and would like to clarify the situation with respect to the above products, as requested.

As you know, synthetic levothyroxine T4 and Liothyronine T3 are available in the UK as licensed medicinal products. Natural desiccated thyroid hormone, which contains both T4 and T3, is extracted from the thyroid glands of pigs, and is marketed in the USA under a number of brands. Some of these brands are marketed under US law as food supplements and as such are not authorised by the Food and Drugs Administration (FDA). These products can vary considerably in the content of thyroid hormones, because they are not standardised, and as a result could potentially be dangerous. However, other brands are authorised by the FDA as medicines, and are standardised to the specification of the United States Pharmacopoeia.

The specification of the USP for the content of T4 (85 to 115% of labelled strength) and T3 (90 to 110%) in natural thyroid tablets are similar to the specifications for the content in the individual synthetic hormones (90 to 110% T4, 90 to 110% T3). Thyroid tablets USP contain approximately 38 micrograms of T4 and 9 micrograms of T3 per 65 milligrams of desiccated thyroid, and are available in a wide variety of strengths.

UK and European law recognises that there may be circumstances when licensed products may not be suitable for some patients. The regulations on medicines allow doctors to prescribe an unlicensed medicine for a patient to meet such a special clinical need, on their own direct personal responsibility. Where these unlicensed medicines are not available in the UK they can be imported by appropriately licensed medicines wholesalers, for supply to a doctor or pharmacy, to meet these needs. The importer is required to notify the MHRA in advance of every occasion that they wish to import such a product.

The MHRA can object to importation of an unlicensed medicine if there are concerns about the safety or quality of the product. The MHRA cannot object to importation of an unlicensed medicine solely on the grounds of efficacy. In the case of these thyroid preparations, the MHRA has not objected to their importation provided that they are authorised prescription only medicines, standardised to the USP, and that they are for the treatment of patients with thyroid diseases, for whom the UK licensed synthetic thyroid hormones are not suitable.

We have not told importers that they must provide evidence from prescribers, as this is a matter of clinical judgement. Consequently, these products can be made available to those people who need them, subject to them being prescribed by a doctor.

I hope that this answers your concerns. If you have any further questions, please do not hesitate to contact me.

Dr Graham Matthews
____________________

THE ABOVE LETTER HAS RECENTLY BEEN UPDATED BY MHRA AND THEIR POSITION IS STILL THE SAME:

From:
MHRA Customer Services [mailto:info@mhra.gsi.gov.uk]
Sent: 06 June 2013 16:35
Subject: RE: Armour Thyroid

Dear Sheila Turner,

Thank you for your recent enquiry; we are sorry to hear of your experience with synthetic thyroxine.

In the UK, thyroid hormones are classified as medicines; however Armour Thyroid is not a licensed medicine in the UK. A medicine can only become licenced if an application is made for a licence (usually by the manufacturer) demonstrating that the product meets the required standards of safety, quality and efficacy, which we will then assess. In our role as regulator we are not in a position to hold product licences ourselves or to solicit for new product licence applications. As Armour Thyroid is not licensed in the UK we do not have any information as to its safety, quality or efficacy.

Synthetic levothyroxine and Liothyronine (which are known as T4 and T3 respectively) are available in the UK as licensed medicinal products. Natural desiccated thyroid hormone, which contains both T4 and T3, is extracted from the thyroid glands of pigs, and is marketed in the USA under a number of brands. Some of these brands are marketed under US law as food supplements and as such are not authorised by the Food and Drugs Administration (FDA, effectively our counterparts in the USA).

These products can vary considerably in the content of thyroid hormones, because they are not standardised.

UK and European law recognises that there may be circumstances when licensed products may not be suitable for some patients. The regulations on medicines allow doctors to prescribe an unlicensed medicine (such as Armour Thyroid) for a patient to meet such a special clinical need, on their own direct personal responsibility. Where these unlicensed medicines are not available in the UK, they can be imported by appropriately licensed medicines wholesalers, for supply to a doctor or pharmacy, to meet these needs.

The importer is required to notify the MHRA in advance of every occasion that they wish to import such a product.

The MHRA can object to importation of an unlicensed medicine if there are concerns about the safety or quality of the product. The MHRA cannot object to importation of an unlicensed medicine solely on the grounds of efficacy. In the case of these thyroid preparations, the MHRA has not objected to their importation provided that they are authorised prescription only medicines, standardised to the USP, and that they are for the treatment of patients with thyroid diseases, for whom the UK licensed synthetic thyroid hormones are not suitable. Consequently, these products can be made available to those people who need them, subject to them being prescribed by a doctor.

The decision to prescribe this product lies with a patients GP. A GP is under no obligation to prescribe an unlicensed medicine, but can do so if they believe it to be the best treatment available to their patient.

When a doctor prescribes an unlicensed medicine to their patient, they are taking direct responsibility for their patient’s health, although, they may first need to obtain guidance or permission locally.

Licensed medicines must demonstrate they meet high standards of safety, quality and efficacy before they are approved and a doctor does not have the same assurances for unlicensed medicines. Decisions on whether the prescribing of an unlicensed medicine would be funded by the NHS or whether the patient would have to pay on a private prescription are not within the remit of the MHRA.

We hope you find this information helpful.

Kind Regards,
Ben,
Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
Tel: 020 3080 6000

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MHRA confirmation re Nature-Throid and Westhroid that NHS doctors are allowed to prescribe this in the same way as they are allowed to prescribe Armour Thyroid

Please could you let me know if NHS medical practitioners can prescribe Nature Throid and Westhroid in the same way they can prescribe Armour Thyroid, USP for those patients who do not do well on levothyroxine alone. Please see letter sent to me by Dr Graham Matthews in 2004 about the prescribing of Armour Thyroid.

___________________

Dear Ms Turner,

Nature Throid and Westhroi
d Natural Desiccated Porcine Thyroid Extract

Thank you for your recent enquiry to the MHRA.

We can confirm that the situation as stated in the original letter also applies to these two products but please note that where the letter states “We have not told importers that they must provide evidence from prescribers, as this is a matter of clinical judgement. We do reserve the right to request this information should we deem it necessary.

We do not normally object to importation of the products you have named. However please note that even though a Prescriber may be able to prescribe anything they wish, this does not mean that it can necessarily be obtained especially if the MHRA were to object to importation of an imported unlicensed medicine.
Please contact us again if you need further assistance with this, or any other queries.
Kind Regards,

Ben
On behalf of the Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
____________________

From: MHRA Information Centre [mailto:info@mhra.gsi.gov.uk]
Sent: 10 November 2009 13:44
To: sheila@tpauk.com
Subject: RE: Armour Thyroid, Nature Throid, Westhroid and Canadian ‘Erfa ‘Thyroid’

Dear Sheila Turner,

Thank you for your recent enquiry to the MHRA.

We have no say on what may be prescribed on the NHS, however we do not generally object to importation of thyroid products intended for the special clinical needs of patients where there are no overiding concerns over the safety or quality of the products in question. We will treat the “Erfa” product in the same way as other unlicensed medicines and in fact we have not objected to notifications for importation of the “Erfa” range of products.

Please contact us again if you need further assistance with this, or any other queries.

Kind Regards,
Ben,
on behalf of the
Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000

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