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Coralie Phillips and Donna Roach Letter to the United States Food and Drug Administration (FDA)

druginfo@fda.hhs.gov
cderombudsman@fda.hhs.gov

CDER OMBUDSMAN
WHITE OAK BUILDING 51
ROOM 6158
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993
USA

TEL: 001 888 463 6332

Subject: URGENT HELP REQUIRED Re: Natural Desiccated Thyroid Treatment Availability

Dear Sir or Madam,

My identical twin sister and I have been made aware that the availability of natural desiccated thyroid treatment is under threat both now and in the future as a result of the FDA’s decision to stop companies from manufacturing and selling natural desiccated thyroid treatment until they have undergone the FDA drug approval process which could take a considerable period of time. Please could you clarify the extent of this situation?

However, it is imperative that the FDA realises that patients both in the USA and UK and elsewhere who cannot tolerate synthetic thyroid treatment and/ or who cannot recover on synthetic thyroid treatment need to continue to receive their natural desiccated thyroid treatment as prescribed by their doctor and gaps in the availability of this treatment could have dire consequences.

My twin sister and I have hypothyroidism and are dependent on prescriptions of natural desiccated thyroid treatment for our ongoing health, wellbeing and survival for the rest of our lives. We were unable to recover from previously undertreated hypothyroidism on synthetic thyroid treatment and developed intolerance difficulties when taking synthetic thyroid treatment and therefore it was realised that in our case it was necessary for us to be prescribed natural desiccated thyroid treatment which we have been receiving from the USA via the UK National Health Service. Although we live in the UK, we are reliant on natural desiccated thyroid treatment from the USA. Our experiences have been documented in our book, ‘Hypothyroidism in Childhood and Adulthood A personal perspective and scientific standpoint’ which was published by Nottingham University Press in 2006.

Unfortunately, synthetic thyroid treatment is not a suitable alternative for ourselves and other hypothyroid patients like us. Therefore, unavailability of natural desiccated thyroid treatment would be catastrophic for us and other patients such as ourselves. Please could you send us confirmation that the FDA will reverse any decision that prevents sufficient quantities of natural desiccated thyroid treatment from being made available on a continued basis in and from the USA as a matter of urgency? What contingencies would there be for patients such as ourselves if the companies concerned decided to discontinue production of natural desiccated thyroid treatment rather than go through the approval process?

Please could you provide us with the name and address of a suitable contact at the FDA so that we can provide a copy of our book in support of ourselves and others who are reliant on natural desiccated thyroid treatment in order to live and thrive so that you can comprehend the necessity of reversing any FDA decision that makes natural desiccated thyroid treatment unavailable to hypothyroid patients?

Yours faithfully,

Coralie Phillips & Donna Roach
www.thyroidbooks.co.uk

CC: Various interested parties

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