2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC12
Submitter : Mr. Bradley White Date & Time: 12/19/2005 12:12:25
Organization : Medicine Shoppe Pharmacy
Category : Health Professional
Issue Areas/Comments
Wyeth wrongly presumes that FDA?s authority extends completely across every facet of the practice of compounding. This is incorrect; pharmacy compounding is a wholly distinct practice and is not subject to the same requirements as manufacturing. Since the Food, Drug, and Cosmetic Act of 1938 passed, compounding has been regulated by state boards of pharmacy, not the FDA. In fact, because compounded bioidentical hormone replacement therapies are prepared to meet patients? individual needs, they are inherently incompatible with the FDA?s years-long new drug approval process required of manufactured pharmaceuticals.

Wyeth mischaracterizes the First Amendment protections to commercial speech and misconstrues the U.S. Supreme Court?s Western States ruling. Wyeth is trying to undermine the Supreme Court?s decision, which found that ?prohibitions on soliciting prescriptions for, and advertising, compounded drugs amount to unconstitutional restrictions on commercial speech.? While the court also affirmed that ?misleading? advertisements are not protected by free speech ? a ruling IACP supports and its policy reflects ? Wyeth?s condemnation of virtually any communication regarding BHRT is excessively broad, contrary to Western States, and would violate the First Amendment if enforced by the FDA.

Wyeth relies on bad science to support many of its claims. The only study Wyeth uses to support its contention that compounding is unsafe has been criticized in the U.S. Senate and is not supported even by the FDA. When pressed on the scientific value of the data during an October 2003 Senate hearing on pharmacy compounding, FDA?s then acting director of the Center for Drug Evaluation and Research, Dr. Steven Galson, explained, ?I wasn't trying to present these as scientific data. Most notably, I wasn't trying to use them to urge or call for a new Federal regulation.?

In its filing, Wyeth itself blurs the line between synthetic and bioidentical hormones. Most notably, Wyeth suggests that the National Institutes of Health Women?s Health Initiative (WHI) studied bioidentical hormone therapies. It did not. Rather, WHI studied Wyeth?s products exclusively and the study was cut short in 2002 after the data demonstrated that Premarin? (conjugated estrogen) increased the risk of stroke and the components of Prempro?, Premarin plus the progestin medroxyprogesterone acetate (synthetic progesterone), increased the risk of strokes, breast cancer, heart attacks and blood clots. According to Wyeth?s latest annual report, sales of Premarin-related products suffered since the study ended, having declined about 32 percent to $880 million in 2004 from $1.3 billion in 2003. The physical components of BHRT are different from the components of Wyeth?s synthetic hormones that were studied by WHI.

Furthermore, Wyeth has had its own problems with FDA rules governing advertising. In a letter from FDA dated January 11, 1999, the FDA said that promotional materials for Premarin were "false or misleading, and promote Premarin for unapproved uses." One year earlier, the company had received a letter saying that a television advertisement for Premarin was "false or misleading."