2005N-0137 Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
FDA Comment Number : EC13
Submitter : Mr. Gary Bloom Date & Time: 07/28/2005 06:07:07
Organization : ThyCa: Thyroid Cancer Survivors' Association, Inc.
Category : Consumer Group
Issue Areas/Comments
GENERAL
GENERAL
Regarding:
Docket: 2005N-0137 - Levothyroxine Sodium Therapeutic Equivalence; Public Meeting

We are writing on behalf of ThyCa: Thyroid Cancer Survivors' Association, Inc. (thyca.org).

Thyroid cancer is one of the few cancers that is increasing in incidence. ThyCa is a national nonprofit 501(c)(3) organization advised by nationally recognized thyroid cancer specialists. ThyCa provides free education and support for patients, families, and the public. Our services include support groups, publications, workshops, and conferences. We have 8,000-10,000 participants in our support groups alone. Our web site (thyca.org) receives more than 200,000 hits each month.

We ask the FDA to support the recommendations of the American Thyroid Association, American Association of Clinical Endocrinologists, and The Endocrine Society regarding levothyroxine sodium.


ThyCa does not support or oppose any brand of levothyroxine sodium products. Our physicians prescribe all brands of levothyroxine sodium.

However, it is essential to thyroid cancer patients that a pharmacy not switch brands, even at the same dose.

Patient safety and prevention of recurrence of thyroid cancer are our paramount concerns. Thyroid cancer patients need to stay on the same brand of levothyroxine. If the brand is switched, re-testing for TSH is required, because different brands are absorbed differently, even at the same dose. This re-testing is both expensive and life-disrupting for the thyroid cancer patient.

Brand switching is to be avoided because thyroid cancer patients need blood levels of thyroid stimulating hormone (TSH) to stay at the target level needed for our individual circumstances.

A precise TSH level helps prevent growth or recurrence of the most common types of thyroid cancer. Dose changes prescribed by our physicians are small, usually less than 10%. For these reasons, our web site's Know Your Pills page explains key points about levothyroxine and the importance of avoiding changing brands, because changing brands requires the expense and life disruption of having to go for a re-test for TSH level.

We urge the FDA to use the analysis and guidance of the leading endocrinologists on the crucial issues related to levothyroxine sodium bioequivalence. These endocrinologists are experts on thyroid issues and thyroid patient care. We patients benefit every day from their knowledge and expertise. We greatly appreciate their dedication to patient well-being.

In addition, we agree that further bioequivalence studies are needed prior to the FDA's allowing brand switching. With over 300,000 thyroid cancer
survivors, all of whom are dependent upon thyroid hormone for their survival because they have no thyroid remaining, we are confident that more than enough thyroid cancer survivors would volunteer to participate in needed bioequvalence studies.

As we noted in our comments at the public meeting in May 2005 strongly support the analysis and recommendations of the leading endocrinologists and the American Thyroid Association, American Association of Clinical Endocrinologists, and The Endocrine Society.

As thyroid cancer patients, we ask you to support their recommendations. Thank you again for your time and consideration.

Sincerely,
Gary Bloom, Board Chair
and Cherry Wunderlich, Outreach Coordinator,
ThyCa: Thyroid Cancer Survivors' Association, Inc. (thyca.org)
PO Box 1545, New York, NY 10159-1545
Toll-Free 1-877-588-7904
Fax 1-630-604-6078
thyca@thyca.org

Gary Bloom's Mailing Address:
2604 Thistledown Terrace, Olney, MD 20832

ThyCa: Thyroid Cancer Survivors' Association, Inc. (thyca.org)
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