SUGAR LAND, Texas, Oct. 27 /PRNewswire/ -- Today the International Academy of Compounding Pharmacists (IACP) sharply criticized pharmaceutical manufacturer Wyeth for manipulating the law and facts in an attempt to restrict patients' access to customized bioidentical hormone replacement therapy (BHRT). On October 6, 2005, Wyeth petitioned the Food and Drug Administration (FDA) to impose far-reaching restrictions on physicians' ability to prescribe and pharmacists' ability to prepare and dispense bioidentical hormones. "Wyeth's aims are clear: to restrict the ability of physicians to prescribe and patients to use customized BHRT following studies that have raised serious health concerns with the company's own products," said L.D. King, executive director of IACP. "When Johnson and Johnson discovered that Tylenol had been contaminated, it didn't file a petition to limit access to ibuprofen; it acted responsibly and fixed the problem. Wyeth would be wise to follow this responsible course." IACP said that one example of Wyeth's contorted logic in the petition is that the company is trying to have it both ways: arguing that bioidentical hormones are illegal because they are copies of off-the-shelf pharmaceuticals on the one hand, and claiming that compounding pharmacists are fabricating new, untested drugs on the other. The truth is that compounding pharmacists are preparing bioidentical hormone replacement therapies, which doctors design and prescribe to meet their patients' individual needs. The organization also said the Wyeth petition is trying to mislead FDA by suggesting that compounding pharmacists are "simply trying to dupe an unsuspecting patient population." Wyeth knows full well that physicians must prescribe BHRT for each patient before a pharmacist can provide her with this medicine, just as they would order Wyeth's own medications. Yet Wyeth completely ignores the role physicians play, never mentioning them in the petition. To suggest that pharmacists who prepare customized medicines based on doctors' orders are duping patients is an insult to all physicians, patients and pharmacists, the organization said. IACP said it will formally oppose the Citizen Petition in its own response to FDA in the weeks ahead. The organization cited a number of other substantive flaws with the Wyeth petition. * 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(R) (synthetic estrogen) increased the risk of stroke and the components of Prempro(R), Premarin plus progestin (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." As the Cincinnati Enquirer reported this month, "For some women, hormone replacement therapy is the only thing that eases symptoms. More women are turning to bioidentical hormones -- custom-compounded mixes of estrogens and progesterone that are identical to hormones produced by the body." Continued Mr. King, "Pharmacy compounding is performed by responsible, trained professionals who have strong relationships with their patients and their patients' physicians. The successful practice of pharmacy compounding is predicated on full, open and honest communication between these three groups of people. However, by attacking these communications and the ability to treat patients, Wyeth's petition would do far more harm than good. As a result, IACP will request that the FDA deny Wyeth's petition." About IACP The International Academy of Compounding Pharmacists (IACP) is a non- profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
SOURCE International Academy of Compounding Pharmacists