Hormones :: AMA Adopts Resolution Calling for FDA Oversight of Bioidentical Hormones
The American Medical Association?s (AMA) House of Delegates unanimously and enthusiastically passed a resolution introduced by The Endocrine Society and other concerned organizations urging the U.S. Food and Drug Administration (FDA) to increase its oversight and regulation of so-called bioidentical hormones.
?The Endocrine Society applauds the AMA for helping to bring much-needed oversight to bioidentical hormones,? said Dr. Leonard Wartofsky, president of The Endocrine Society.
Public interest in bioidentical hormones has been fueled recently by articles and books in the popular press touting them as safer and more effective alternatives to traditional hormone therapies, though little or no scientific and medical evidence exists to support these claims.
Technically, bioidentical hormones are compounds that have the same chemical composition as hormones produced naturally in the body. The term, however, is commonly used by those outside the medical community to describe custom-made hormone treatments from compounding pharmacies that are individually tailored based on the results of saliva tests. The accuracy and usefulness of such tests, however, is highly questionable.
Patients can obtain bioidentical hormones as either FDA-approved drugs that are formulated with strict oversight and dispensed by retail pharmacies, or as non-FDA approved dosages and formulations (such as topical creams) from compounding pharmacies.
Since the final hormone formulations of most compounding pharmacies are not subject to FDA monitoring for dose, purity, safety, or efficacy there may be additional, and at this point unknown, risks associated with them. Post-market surveys of such hormone preparations have uncovered inconsistencies in dose and quality.
?The inconsistencies and unknown risks of bioidentical hormones are of great concern,? said Wartofsky. ?Without proper oversight and control, the public has no way of knowing precisely what they?re getting or what effect it will have on an individual?s body.?
The Endocrine Society recently adopted a position statement calling for increased regulatory oversight of bioidentical hormones, which provided the basis for the AMA resolution. When the AMA adopts a resolution, it becomes official AMA policy.
The resolution ? which was introduced by The Endocrine Society, the American Association of Clinical Endocrinologists, and the American Society of Reproductive Medicine ? states that the:
? AMA urge the Food and Drug Administration to conduct surveys for purity and dosage accuracy of all compounded bioidentical hormone formulations; and
? AMA urge the Food and Drug Administration to require mandatory reporting by drug manufacturers, including compounding pharmacies, of adverse events related to the use of bioidentical hormones; and
? AMA urge the Food and Drug Administration to create a registry of adverse events related to the use of compounded bioidentical hormone preparations; and
? AMA request that the Food and Drug Administration require the inclusion of uniform patient information, such as warnings and precautions, in packaging of compounded bioidentical hormone products; and
? AMA urge the Food and Drug Administration to prohibit the use of the term ?bioidentical hormones? unless the preparation has been approved by the FDA.
Several physicians representing a range of specialties rose on the floor of the House of Delegates to speak in support of The Endocrine Society?s resolution, including the American College of Obstetricians and Gynecologists and the American Academy of Family Practitioners. ?With this vote, it is clear that organized medicine recognizes that FDA oversight of bioidentical hormones is critical to ensure patient safety,? said Wartofsky. ?The Endocrine Society looks forward to working with the AMA to advocate strongly for a meaningful policy change.?
Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 13,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md.