SUGAR LAND, Texas, Dec. 15 /PRNewswire/ -- The International Academy of Compounding Pharmacists (IACP) today called on the Food and Drug Administration (FDA) to protect women's access to bioidentical hormones by rejecting a Citizen Petition filed earlier this year by pharmaceutical giant Wyeth. IACP represents about 1,800 pharmacists, patients and physicians who recognize that compounded medicines are a vital part of modern, individualized healthcare.
On October 6, 2005, Wyeth petitioned the FDA to impose far-reaching restrictions on physicians' ability to prescribe, pharmacists' ability to prepare and patients' ability to take bioidentical hormones. In fact, Wyeth's proposal is so far-reaching that it would endanger all patients' access to compounded medications broadly.
"Wyeth's use of a so-called 'citizen' petition is absurd at best," said L.D. King, executive director of IACP. "At worst, though, it is corporate manipulation of a process intended to empower citizens who don't enjoy the benefit of multi-million dollar political action committees and armies of lobbyists. The petition does not aim to protect women's health, just Wyeth's wealth."
As stated in IACP's filing, Wyeth's petition is filled with major legal and factual errors, inaccuracies, and mischaracterizations. Even the filing itself is improper: a Citizen Petition may not be used to request enforcement actions.
In its filing, IACP also calls attention to the fact that the vast majority of ostensibly independent organizations that filed comments with the FDA in support of Wyeth's petition have ties -- financial and otherwise -- to the company. These groups include: Society for Women's Health Research; Jacob's Institute for Women's Health; American Medical Women's Association; National Association of Nurse Practitioners in Women's Health; National Black Women's Health Project; the American Society of Reproductive Medicine; and the North American Menopause Society.
"These organizations and Wyeth must operate transparently," continued Mr. King. "One of these organizations received $75,000 from Wyeth to be a 2005 'Ruby Sponsor,' for example. The organizations have credibility because they are perceived to be independent and unbiased. But if there are financial links between Wyeth and these organizations, then this is a material disclosure that the public and FDA officials must be made aware of so that they can accurately measure these organizations' credibility and impartiality."
IACP's filing calls attention to a number of other issues, including:
* Wyeth mischaracterizes pharmacy compounding by deliberately ignoring the crucial role of the physician. The Citizen Petition portrays compounding pharmacies as if they were selling BHRT preparations directly to hapless patients. However, the 36-page Citizen Petition never once acknowledges that compounding pharmacies operate within the physician/patient/pharmacy triad, and that no prescription is compounded and provided to patients without receipt of a prescription from the patient's physician.
* Wyeth equates compounding with manufacturing. Contrary to Wyeth's characterization of compounding pharmacies as manufacturers that churn out uniform products, compounding pharmacies that compound BHRT prepare medicines that are customized to individual needs. The advertisements and promotional materials Wyeth cites make clear that BHRT preparations are compounded based on the needs of the individual, not mass-produced like Wyeth's products. Each Wyeth drug is offered in a single formulation. In sharp contrast, compounding pharmacies compound customized therapies based on the evaluation of the woman's physician as to what formula would be best for her.
* Wyeth accuses pharmacists that compound BHRT of copying Wyeth's drugs. For more than a decade, Wyeth has successfully fended off generic competition to its conjugated estrogen products by asserting that the active ingredients in the conjugated estrogen products could not be adequately identified and, therefore, that there can be no generic copy of Premarin -- and presumably its other pregnant mare urine-based drugs in its stable -- because the precise characteristics of the drug cannot be characterized. As such, compounded hormones are not copies of commercially available drugs, because according to Wyeth's own arguments, acquiesced to by FDA, there can be no copies of Wyeth's pregnant mare urine-based drugs. Given that Wyeth has repeatedly maintained to FDA that no drugs can be the same as its products, and that the hormones compounded by pharmacists are tailored to individual patients, compounded hormones are not the same as Wyeth's.
* Wyeth tries to use advertising as something that distinguishes pharmacist from manufacturer. Wyeth asserts that educational promotional materials distributed by compounding pharmacies transform those pharmacies into manufacturers. Wyeth and its counsel ignore compounding pharmacies' First Amendment rights -- affirmed recently by the U.S. Supreme Court -- to engage in commercial speech. This is somewhat surprising given that Wyeth's legal counsel (which submitted the Citizen Petition) was responsible for submitting the briefs and arguing one of the seminal cases asserting that the First Amendment free speech protections limited FDA's ability to regulate communications about prescription drugs.
* Compounded medications are not unapproved new drugs and do not require new drug approval. Paradoxically, Wyeth argues both that compounded BHRT preparations are copies of Wyeth's mare-urine based drugs while at the same time (and on the same page) arguing that the compounded BHRT preparations are unapproved new drugs. Wyeth cannot have it both ways. The fact is that bioidentical hormones are not copies of Wyeth's drugs, but are unique -- and entirely legal -- medications prescribed by physicians and compounded by pharmacists to meet their patients' unique needs.
According to a 1997 report from Citizens Against Government Waste, a Washington, D.C.-based think tank, Wyeth waged a political campaign to influence FDA's decision to keep a generic version of Premarin off the market. This is the campaign, referenced above, in which Wyeth asserted that its products could not be copied by generic manufacturers. Wrote CAGW: "Although the FDA and Premarin's manufacturer, Wyeth-Ayerst, would like the American public to believe that this decision was in their best interests, the reality is that it was driven by hoards of lobbyists, fraught with conflicts of interest, and characterized by questionable behind-the-scenes political maneuvering."
"Wyeth and its allies appear -- once again -- to be conducting a political campaign to protect Wyeth's market share," continued King. "While they may have enjoyed success at the expense of women before, they will not be successful this time. Far too many women, in consultation with their physicians, rely on bioidentical hormones -- and they are far too passionate a group to let Wyeth get in between them, their doctors and their hormone treatments."
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.
International Academy of Compounding PharmacistsCONTACT: Joshua Wenderoff, +1-202-777-3502, or jwenderoff@clsdc.com, forthe International Academy of Compounding Pharmacists
