Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing

Dr. Donna Shoupe, a professor of Obstetrics and Gynecology at the University of Southern California School of Medicine, argues that estrogen-androgen combination drugs are vital for treating various menopausal symptoms and conditions like osteoporosis. She emphasizes the need for individualized hormone therapy and urges the FDA to keep these medications available to provide patients with necessary treatment options.

Dr. Lawrence G. Raisz, a professor and director at the University of Connecticut Center for Osteoporosis, argues in favor of maintaining the availability of estrogen-androgen combination drugs. He highlights their clinical benefits for bone density and formation in postmenopausal women who do not respond well to estrogen alone, noting that the combination pill also improves patient compliance.

Dr. Lorraine A. Fitzpatrick, a Professor of Medicine and Director of the Women’s Health Fellowship, opposes the FDA's withdrawal of estrogen-androgen combination drugs. She argues that these medications are essential for treating vasomotor symptoms and improving quality of life for a large population of postmenopausal women.

Dr. Nelson B. Watts, a Professor of Medicine at Emory University, opposes the FDA's decision to restrict estrogen-androgen combination drugs. He argues that these combinations are necessary to treat androgen deficiency symptoms in postmenopausal women and that removing them would negatively impact patient quality of life.

Dr. James A. Simon, a clinical professor at George Washington University, argues against the FDA's decision to deny an ANDA for ESTRATEST® Brand Tablets. He contends that the FDA has reached inaccurate conclusions regarding the patient population for estrogen-androgen combination therapy and emphasizes the clinical necessity of these drugs for women who do not achieve symptom relief with estrogen alone.

Dr. Edward L. Klaiber, a reproductive endocrinologist, argues that estrogen/androgen combination drugs are necessary for treating libido loss and vasomotor symptoms in menopausal women. He urges the FDA to approve the ANDA for Estratest and Estratest HS to ensure women have access to effective hormone replacement therapy.

Dr. Alan M. Altman, an Assistant Clinical Professor at Harvard Medical School, opposes the FDA's decision to withdraw the NDAs for estrogen/androgen combination drugs. He argues that these medications are essential for treating a well-documented patient population, particularly women with surgical menopause or those who do not respond to traditional hormone replacement therapy.

Karen L. Giblin, President of Prime Plus, Inc., opposes the FDA's proposal to withdraw approval of three estrogen/androgen combination drugs. She argues that these drugs provide significant benefits for menopausal women, particularly those who have undergone surgical menopause, and contends that the patient population in need of such therapy is much larger than the FDA estimates.

Dr. James D. Studdard, a practicing gynecologist, argues that the combination pill Estratest@ should remain available as a therapeutic option for postmenopausal women. He contends that the drug is more effective than estrogen alone for many patients, improves treatment compliance, and provides a necessary dosage that avoids the side effects of male-oriented androgen products.