FDA Cracks Down on Natural Hormone ClaimsJan 10, 2008 | Parker Waichman LLP
Yesterday, U.S. health officials warned seven pharmacy operators that their claims over the safety and effectiveness of bioidentical hormones were false, misleading, and not supported by medical evidence. The Food & Drug Administration (FDA) ordered the companies to stop making these claims about the unproven drugs, saying the businesses claimed their compounds could prevent or treat serious illnesses such as Alzheimer’s disease, stroke, and cancer; they claimed their compounds were superior to approved commercial medications; and they used the hormone estriol, a weak, non FDA-approved estrogen. The FDA says the term bioidentical has no accepted meaning.
Pharmacies are legally permitted to compound their own drugs if they receive a doctor's prescription for a product not otherwise commercially available. FDA officials stressed that they are not cracking down on all forms of compounding. Traditional compounding is the combining or altering of ingredients by a pharmacist, in response to a doctor's prescription, to produce a drug tailored to an individual patient's special medical needs. It is suspected that thousands of pharmacy operators are selling bioidentical hormones.
Terry Scarborough, an attorney for one of the pharmacies said a group of pharmacists has sued the federal government, arguing the FDA has no authority to regulate compounded drugs. Meanwhile, Wulf Utian, executive director of the North American Menopause Society, praised the FDA's action, discouraging women from turning to compounded hormones, saying that "If there is a reason to be on hormone therapy, there are more than enough approved products out there."
Bioidentical hormones are made by tailoring medicines to patients when doctors deem FDA-approved versions inappropriate. The International Academy of Compounding Pharmacists said the FDA action would deny women access to products that may help when approved therapies do not. Drug maker Wyeth, which sells the FDA-approved hormone replacement therapies Prempro and Premarin, asked the FDA in 2005 to take action against makers of bioidentical hormones. Compounding pharmacies protested, and the FDA says it received nearly 70,000 comments from both sides.
Women began using these custom-made treatments when a 2002 study found traditional brand-name drugs may increase the risk of heart attack, breast cancer, or stroke. Bioidentical hormone makers allege their custom-made compounds are tailored to a woman's individual needs based on her saliva. Actress Suzanne Somers has promoted them; however, Kathleen Uhl, director of the agency's Office of Women's Health, says saliva tests aren't reliable as hormones fluctuate hourly, adding that tailor-made hormone therapies pose the same risks as commercially prepared hormone therapies. Uhl said the FDA does not know how widely these drugs are used, but that they have received a growing number of questions about them. Women need to know that all drugs have both benefits and risks, and that patients should discuss them with their doctor, Uhl said.
The market for BHRTs—bioidentical hormone replacement therapies—emerged when doctors deemed prescription estrogen therapy too risky for many patients; a 2002 study found replacement hormones made by drug companies raised the risk of heart attacks, breast cancer, and strokes. Many say that BHRT is not supported by medical evidence and pharmacy operations are breaking the law by making false and misleading claims about the drugs.