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December 15, 2005 - IACP to FDA: Reject Wyeth's Baseless, Self-Serving Petition; Protect Women's Access to Bioidentical Hormones
December 15, 2005
FOR IMMEDIATE RELEASE
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
IACP to FDA: Reject Wyeth’s Baseless, Self-serving Petition;
Protect Women’s Access to Bioidentical Hormones
SUGAR LAND, Texas - 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 broad 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.”
Click here (.pdf) to view a copy of IACP's filing.
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.
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October 27, 2005 - IACP Finds Numerous Flaws with Wyeth Citizen Petition Regarding BHRT
October 27, 2005
FOR IMMEDIATE RELEASE
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
IACP Finds Numerous Flaws with Wyeth Citizen Petition Regarding Bio-identical Hormone Replacement Therapy
SUGAR LAND, Texas - 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® (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."
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.
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May 1, 2005 - Pharmacy Compounding Accreditation Board Hires Executive Director
FOR IMMEDIATE RELEASE
May 1, 2005
Washington, DC - Kenneth R. Baker, R.Ph., J.D has been selected as Executive Director of the Pharmacy Compounding Accreditation Board (PCAB). Baker will assume his duties on May 1, 2005. The PCAB is a coalition of leading pharmacy-related professional and regulatory organizations established to recognize those compounding pharmacies that meet the highest standards of quality, to assist all compounding pharmacies to attain those standards and to raise the awareness of the practice of pharmacy compounding.
Mr. Baker earned his pharmacy degree at the Purdue University, where he also served as Vice President of his APhA Student chapter. Following graduation, he practiced pharmacy in both independent and chain settings, including several years as manager of a chain pharmacy in Indianapolis, Indiana.
A cum laude graduate of Indiana University School of Law, Baker practiced general trial law in Lebanon and Indianapolis for thirteen years, including two and a half years as deputy prosecutor for Boone County Indiana. Among his other accomplishments, he writes and lectures extensively on pharmacy law, liability, quality assurance and ethics issues. He also served as Adjunct Assistant Professor at the University of Iowa College of Pharmacy where he taught Pharmacy Law and Ethics. In 1988, Baker joined the Pharmacists Mutual Insurance Company in Algona, Iowa, and most recently served the Company as Senior Vice President and General Counsel.
As Executive Director of PCAB, Baker will lead the accreditation programs and initiatives designed to support compounding pharmacies in their efforts to continuously improve quality practices and enhance patient care.
PCAB consists of the following organizations: the American College of Apothecaries, the American Pharmacists Association, the International Academy of Compounding Pharmacists, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, the National Council of State Pharmacy Association Executives, the National Home Infusion Association, and the United States Pharmacopeia.
CONTACTS:
| DC Huffman ACA 901-383-8119 aca@acainfo.org |
Gail Street APhA 202-429-7558 gstreet@aphanet.org |
LD King IACP 281-933-8400 ldking@iacprx.org |
| Karen Oster NABP 847-698-6227 koster@nabp.net |
Deleisa Johnson NCPA 703-838-2686 deleisa.johnson@ncpanet.org |
Lorrie Kline Kaplan NHIA 703-838-2658 lorrie.kaplan@nhianet.org |
| Becky Snead NCSPAE 804-285-4145 becky@ncspae.org |
Sherri Borden USP 301-816-8268 slb@usp.org |
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