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

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.

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.