In a significant victory for physicians and patients, the U.S. Food and Drug Administration (FDA) announced on January 9 that it has begun enforcement action against seven compounding pharmacies making false and misleading claims about the safety and efficacy of "bioidentical hormones." The announcement was made in a press release and by teleconference, during which Agency representatives also stated that the FDA considers the term "bioidentical" to be a marketing term and not one of scientific or medical merit. FDA officials repeatedly stated that the claims being made about safety and efficacy of compounded "bioidentical hormones" are false and misleading, with no credible scientific evidence to support them.

Since 2006, the Society has been spearheading an effort to advocate for appropriate regulation of so-called bioidentical hormones. The FDA's action is consistent with the recommendations in The Endocrine Society's position statement issued in October 2006, which was subsequently adopted as official policy of the American Medical Association. The FDA action follows Society Past-President Leonard Wartofsky's invited testimony last year during a U.S. Senate Special Committee on Aging hearing on this issue and the Society's meetings with officials from the FDA Office of Women's Health (OWH) and Center for Drug Evaluation and Research. The FDA's current enforcement action against these compounding pharmacies clearly indicates that the Society's active advocacy for stricter oversight of compounded "bioidentical hormones" has had an impact.

FDA also announced during the teleconference that it has issued its ruling on a citizen petition requesting oversight, regulation, and accurate information on "bioidentical hormones," initiated by Wyeth Pharmaceuticals in October 2005. (The ruling can be viewed here.) While not discussing details of the ruling, the Agency did state that it denied some of the requests of the petition and granted some others. One granted request was for greater public outreach to inform women of the truths and untruths of "bioidentical" hormone replacement therapy. On its Consumer Health Information Page, the FDA has posted a new Consumer Update, titled "Bio-Identicals: Sorting Myths from Facts" (available at http://www.fda.gov/consumer/updates/bioidenticals010908.html). The new online publication also provides links to long-standing information available on the OWH Web site.

The Endocrine Society supports the FDA's action against compounding pharmacies engaged in the harmful practices of false advertising and applauds its expanded efforts to arm patients and healthcare providers with valid and reliable information about all forms of hormone replacement therapy. For more information, please contact Janet Kreizman, senior director of government and public affairs, at jkreizman@endo-society.org.