Bioidentical Hormones - U.S. Senate Special Committee on Aging

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Written Testimony of
Steven F. Hotze, MD
Before the <strong>Senate</strong> <strong>Special</strong> Aging <strong>Committee</strong> on April 19, 2007
Federal intervention into the practice of pharmacy, specifically compounding pharmacy,
would prove detrimental to the health of many Americans. As a physician who has used
compounded pharmacy medications for years and who currently owns a compounding
pharmacy, I have a unique perspective on ensuring compounded drugs are readily available
to the patients who need them. It is common for physicians to determine that manufactured
off the shelf prescription drugs are inadequate to meet the medical needs of an individual
patient. Compounding pharmacy helps ensure the individualized treatment that patients
both need and demand.
Pharmacists who specialize in compounding prepare customized medications in
accordance with a doctor's prescription. These medications, which are not produced by
pharmaceutical companies, are prepared using FDA approved bulk products and are
provided to meet specific patient needs. Through clinical experience, a physician may
decide to use alternative delivery systems (e.g. suppositories, creams, gels, liquids or
capsules) for a specific medication. Often compounded medications are not commercially
available in the strength requested by the physician. In other cases, a patient may be
allergic to the dyes, additives or excipients found in drugs produced by pharmaceutical
manufacturers. In this situation, the solution is prepared without the allergy causing
ingredients. Compounding pharmacy allows physicians to provide patients with alternative
therapies otherwise not commercially available.
The Food, Drug, and Cosmetic Act (FDCA) of 1938 established the authority of the Food
and Drug Administration (FDA) over the pharmaceutical manufacturing of drugs.
Pharmacies were specifically exempted from FDA regulation and their governance was
delegated to the State boards of pharmacy. At that time, all pharmacies practiced the
compounding of medications. Pharmacies, including compounding pharmacies, should
remain under the regulation of the States.
Most pharmacists, like others in business, realize that their self-interest is best served by
operating their enterprises with the interests of their customers in mind. To do otherwise
would result in a loss of business. State laws address the issue of fraudulent and dangerous
business practices. State boards of pharmacy establish guidelines for safely conducting
pharmacy practices and procedures.
The recent results of the Women's Health Initiative study demonstrate the danger of drug
company, FDA-approved, counterfeit hormones. Compounding pharmacies are able to
offer physicians a natural, safe and effective treatment for women in midlife. That
treatment is biologically identical hormone therapy that provides women with the same
hormones that their bodies used to produce or currently produce in less than adequate
amounts. With the baby boomer population aging, there are millions upon millions of