Bioidentical Hormones - U.S. Senate Special Committee on Aging

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Part 11: National media outreach Campaign materials developed in Part I were publicized-using several different approaches and elements to involve partners. These included FDA Public Affairs 31 <strong>Special</strong>ists; media outreach in both print and radio; Internet advertising; print advertising; outreach to community based organizations; and direct e-mail. Campaign Conclusions Based on the combined circulation totals for all media activities used, projections of membership in the community organizations contacted, and volume of materials ordered, the campaign can account for nearly 100 million times that the menopause message was delivered to peri-menopausal and postmenopausal women. In addition, the materials developed as part of this Congressional mandate continue to be requested and distributed. These materials are free and can be accessed via FDA's Office of Women's Health website (http://wwwfda.gov/womenslmenopauselmht-FS.htiml) and the Federal Clearinghouse at Pueblo (www.pueblo.gsa.gov), and are available in both English and Spanish. An extension of this campaign involves the development of a brochure on FDA-approved medications for menopausal symptoms - which has become available in the past month. This document was created in response to requests from women for an FDA guide that provides basic information about menopausal hormone therapy and describes all prescription.products currently approved by the Agency for this indication. The booklet is not intended to be used in place of the labeling, but to help women talk to their doctor, nurse, or pharmacist about what they should know about risks and side effects, and general safe use for each of these medications. CONCLUSION FDA intends to continue to address pharmacy compounding, including compounding of BHRT products, in a manner that respects traditional pharmacy compounding. FDA will pursue enforcement action against compounded drugs, including compounded BHRT
32 drugs, when the compounding of these drugs raises concerns normally associated with drug manufacturing and results in significant violations of the new drug, adulteration, or misbranding provisions of the FD&C Act. This concludes my testimony, Mr. Chairman. I will be glad to answer any questions you may have.
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 and 26: 22 adulteration and misbranding pro
Page 27 and 28: 24 The 2002 CPG reflects FDA's curr
Page 29 and 30: 26 Equally concerning are claims by
Page 31 and 32: 28 concerned about the use and mark
Page 33: 30 Part I: Materials and Partnershi
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
Page 77 and 78: 74 The FDA also regulates aspects o
Page 79 and 80: Statement of Loyd V. Allen, Jr., Ph
Page 85 and 86:
82 Senator SMITH. Dr. Allen, as I h
Page 87 and 88:
84 Now, when you are talking about
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86 The only thing the WHI proved wa
Page 91 and 92:
88 Testimony Of T.S. Wiley before t
Page 93 and 94:
Confusion and Media Hype 90 Instead
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92 see a doctor tell a diabetic nea
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94 the only compelling reason to ta
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96 identical hormones synthesized f
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98 The world as we know it, from ba
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100 thereby experienced long period
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102 Bio-identical progesterone repl
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104 had reached optimum theoretical
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106 and the patient can be can reas
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108 Estradiol and Analytical Resear
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110 A controlled systematic pilot c
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112 of set doses. The Wiley Protoco
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114 I'd advocate for either Accredi
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116 D.C., and established a goal to
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118 If this legislation passes, fed
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first and second finger on the barr
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122 These products that have been s
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124 Bcl-2, survivin and variant CD4
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126 These are experiments by other
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128 cerebro-cellular inflammation c
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130 Years # women *1>0.5 8 *1+ 9 *2
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*Breast cancer 132 -57 y.o. recurre
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134 *Labor intense for patient and
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136 Senator SMITH. Thank you very m
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138 makes these hormones uniquely s
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140 tomize the Wiley Protocol by ra
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142 "natural," because all lead to
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144 maceutical commerce, often with
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146 WHITE PAPER #1 DID YOU KNOW THA
Page 151 and 152:
148 WHITE PAPER #2 Pharmacy Compoun
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150 bleeding of the bowel, locate t
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152 compounding standards can be en
Page 157 and 158:
154 I. The FDA's definition of a "N
Page 159 and 160:
156 ORIIGINAL CONTrMIBTION JANMA-EX
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Initially, the design allowed women
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ards analyses," stratified by clini
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year). These 'drop-in" rates were a
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years of prior use, 11 vs 2; HR, 4.
Page 169 and 170:
trogen plus progestin exposure. Clo
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168 RISKS AND BENEFITS OF ESTROGEN
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EFFECTS OF POSTMENOPAUSAL ESTIROGEN
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EFFECTS OF POSTMENOPAUSAL ESTROGEN
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Page 179 and 180:
pEyECTS OF POSTMENOPAUSAL ESTROGEN
Page 181 and 182:
Page 183 and 184:
Page 185 and 186:
10000 isoor i I ea '° a wan 20-24
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~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
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Is associated with an Increased ris
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188 Postmenopausal hormone therapy
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group (P= 04001), and In this subgr
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Treatmnent recommendations Based on
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21.Grodsteln F. Manson JE, Colditz
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_ ORWIGNAL CONTIuBUTION 196 Postmen
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showed no striking differences in H
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(214 cases; P for trend=.72): howev
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202 HORMONE THERAPY USE AND RISK OF
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mal studies, and laboratory studies
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Page 211 and 212:
Page 213 and 214:
210 ,lmcCII na: CLI I tr: tarty ver
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212 ,mucmai rimi &ronos farty bstro
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214 LntIucwu miau: rronos nary estr
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XVI. PNharmacy Licensure Requiremen
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XVI. Pharmacy Licensure Requirement
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220 Roster of Board of Pharmacy Ece
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050. 0l7404405400 Al-h. PeVbU 03283
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Conclusions * Age is a powerful ris
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Women's Health Initiative Trials of
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Hormone Therapy after WHI * Change
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Statement of the American Pharmacis
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232 APhA Statement to the S
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Page 241 and 242:
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240 Written Testimony of Steven F.
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242 STATEMENT OF DAVID G. ADAMS On
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244 Report on State Laws and Regula
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246 Only one state, Utah, requires
Page 251:
248 5. Compounding Copies of FDA-Ap
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