Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging
23 law. Under section 503A, compounded drugs that satisfied certain requirements were exempted from three key provisions of the FD&C Act: (1) the adulteration provision of section 501(a)(2)(B) (concerning good manufacturing practice requirements for drugs); (2) the misbranding provision of section 502(f)( 1) (concerning the labeling of drugs with adequate directions for use); and (3) the new drug approval provision of section 505. Thompson v. Western States Medical Center Section 503A included prohibitions on the solicitation of prescriptions for, and the advertising of, compounded drugs. In November 1998, these solicitation and advertising provisions were challenged by seven compounding pharmacies as an impermissible regulation of commercial speech. A federal district court ruled in the pharmacies' favor and held that the solicitation and advertising restrictions violated the First Amendment On appeal, the Ninth Circuit Court of Appeals affirmed the District Court's holding that the solicitation and advertising provisions unconstitutionally restricted commercial speech. The Court also declared section 503A to be invalid in its entirety, meaning that the unconstitutional speech provisions could not be severed from the rest of 503A. Western States Medical Center v. Shalala, 238 F.3Td 1090 (9th Cir. 2001)). The Supreme Court affirmed the Ninth Circuit's decision that the advertising and soliciting restrictions were unconstitutional, but it did not consider whether these restrictions could be severed from the rest of section 503A. Thompson v. Western States Medical Center, 535 U.S. 357 (2002). FDA shares the Ninth Circuit's view that section 503A is now void. Compliance Policy Guide of May 2002 In order to fill the regulatory vacuum created by the Supreme Court's decision in Thompson v. Western States Medical Center, FDA issued Compliance Policy Guide section 460.200 ["Pharmacy Compounding"] in May 2002. FDA issued this CPG in final form, and requested and received numerous comments on it. FDA stated that it would review these comments and revise the CPG, if appropriate. That process is underway, and FDA plans to issue a revised CPG, in draft, for public comment.
24 The 2002 CPG reflects FDA's current enforcement policy with respect to human drug compounding. It recognizes that pharmacists traditionally have extemporaneously compounded reasonable quantities of drugs upon receipt of a valid prescription for an individually identified patient. This traditional compounding is not the subject of the guidance. Instead, the CPG provides that, when the scope and nature of a pharmacy's activity raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the FD&C Act, FDA will consider enforcement action. The CPG identifies factors that FDA evaluates in deciding whether to take action; these factors are not intended to be exhaustive. Medical Center Pharmacy v. Gonzales In 2004, ten pharmacies specializing in compounding brought suit in the United States District Court for the Western District of Texas, challenging FDA's authority to regulate compounded drugs. In August 2006, the court ruled, among other things, that compounded drugs are "implicitly exempt" from the FD&C Act's new drug approval provisions. Medical Center Pharmacy v. Gonzales, 451 F. Supp. 2d 854 (W.D. Tex. 2006). The government has filed an appeal with the U.S. Court of Appeals for the Fifth Circuit. Pending resolution of this appeal, the district court's decision applies in the Western District of Texas. i Elsewhere, FDA continues to be guided by the 2002 CPG when considering enforcement actions regarding compounded drugs. COMPOUNDED BIO-IDENTICAL HORMONE REPLACEMENT THERAPY PRODUCTS FDA is aware that an increasing number of pharmacists compound hormone products for use by postmenopausal women. These pharmacies often promote their products as "bio- identical" to the hormones produced by a woman's body, and the phrase "bio-identical hormone replacement therapy" (BHRT) has been used to describe these products. Compounded BHRT products typically contain various forms of estrogen and progesterone and, in some cases, testosterone and dehydroepiandrosterone. BHRT drugs
- Page 1 and 2: S. HRG. 110-129 Bioidentica
- Page 3 and 4: CONTENTS Page Opening Statement of
- Page 5 and 6: 2 The sale of bioidentical hormone
- Page 7 and 8: 4 ever, as Dr. Wartofsky points out
- Page 9 and 10: 6 with every stage of the disease:
- Page 11 and 12: 8 I am pleased to appear before thi
- Page 13 and 14: 10 When the trials began, many rese
- Page 15 and 16: Women who began treatment more than
- Page 17 and 18: 14 One small trial using oral estra
- Page 19 and 20: 16 FDA is aware that a growing numb
- Page 21 and 22: 18 DEPARTMENT OF HEALTH & HUMAN SER
- Page 23 and 24: 20 safety and efficacy. However, as
- Page 25: 22 adulteration and misbranding pro
- Page 29 and 30: 26 Equally concerning are claims by
- Page 31 and 32: 28 concerned about the use and mark
- Page 33 and 34: 30 Part I: Materials and Partnershi
- Page 35 and 36: 32 drugs, when the compounding of t
- Page 37 and 38: 34 Our staff identified 34 Web site
- Page 39 and 40: 1. Introduction 36 Chairman Kohl, R
- Page 41 and 42: diet and fitness products. 5 For ex
- Page 43 and 44: include "natural" progesterone crea
- Page 45 and 46: 42 unique to the computer age, such
- Page 47 and 48: computer users to spam(ftuce.0ov -
- Page 49 and 50: 46 accuracy of advertising for heal
- Page 51 and 52: 48 Now, you have identified in your
- Page 53 and 54: 50 claim." Therefore, since the ter
- Page 55 and 56: 52 Such quality control problems ha
- Page 57 and 58: 54 Statement Before the U.S. <stron
- Page 59 and 60: in the U.S., whereas WHI participan
- Page 61 and 62: 58 between science and hearsay and
- Page 63 and 64: 60 How can we determine whether bio
- Page 65 and 66: 62 doctors-are not getting the obje
- Page 67 and 68: 64 27. Writing Group for the PEPI T
- Page 69 and 70: 66 Dr. MANSON. Well, I think that m
- Page 71 and 72: 68 Statement of Leonard Wartofsky,
- Page 73 and 74: 70 in the WHI. In fact, no study as
- Page 75 and 76: In summary, the Endocrine Society i
24<br />
The 2002 CPG reflects FDA's current enforcement policy with respect to human drug<br />
compounding. It recognizes that pharmacists traditi<strong>on</strong>ally have extemporaneously<br />
compounded reas<strong>on</strong>able quantities of drugs up<strong>on</strong> receipt of a valid prescripti<strong>on</strong> for an<br />
individually identified patient. This traditi<strong>on</strong>al compounding is not the subject of the<br />
guidance. Instead, the CPG provides that, when the scope and nature of a pharmacy's<br />
activity raise the kinds of c<strong>on</strong>cerns normally associated with a drug manufacturer and<br />
result in significant violati<strong>on</strong>s of the new drug, adulterati<strong>on</strong>, or misbranding provisi<strong>on</strong>s of<br />
the FD&C Act, FDA will c<strong>on</strong>sider enforcement acti<strong>on</strong>. The CPG identifies factors that<br />
FDA evaluates in deciding whether to take acti<strong>on</strong>; these factors are not intended to be<br />
exhaustive.<br />
Medical Center Pharmacy v. G<strong>on</strong>zales<br />
In 2004, ten pharmacies specializing in compounding brought suit in the United States<br />
District Court for the Western District of Texas, challenging FDA's authority to regulate<br />
compounded drugs. In August 2006, the court ruled, am<strong>on</strong>g other things, that<br />
compounded drugs are "implicitly exempt" from the FD&C Act's new drug approval<br />
provisi<strong>on</strong>s. Medical Center Pharmacy v. G<strong>on</strong>zales, 451 F. Supp. 2d 854 (W.D. Tex.<br />
2006). The government has filed an appeal with the U.S. Court of Appeals for the Fifth<br />
Circuit. Pending resoluti<strong>on</strong> of this appeal, the district court's decisi<strong>on</strong> applies in the<br />
Western District of Texas. i Elsewhere, FDA c<strong>on</strong>tinues to be guided by the 2002 CPG<br />
when c<strong>on</strong>sidering enforcement acti<strong>on</strong>s regarding compounded drugs.<br />
COMPOUNDED BIO-IDENTICAL HORMONE REPLACEMENT THERAPY<br />
PRODUCTS<br />
FDA is aware that an increasing number of pharmacists compound horm<strong>on</strong>e products for<br />
use by postmenopausal women. These pharmacies often promote their products as "bio-<br />
identical" to the horm<strong>on</strong>es produced by a woman's body, and the phrase "bio-identical<br />
horm<strong>on</strong>e replacement therapy" (BHRT) has been used to describe these products.<br />
Compounded BHRT products typically c<strong>on</strong>tain various forms of estrogen and<br />
progester<strong>on</strong>e and, in some cases, testoster<strong>on</strong>e and dehydroepiandroster<strong>on</strong>e. BHRT drugs
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