Physicians Urge Unbiased Review of New Emergency Contraceptive; Support New Options to Prevent Pregnancy

Washington, DC—Sara Imershein, MD, was among the expert speakers who testified before the Food and Drug Administration today about a new emergency contraceptive, ulipristal acetate. The FDA is considering whether to approve the drug for prescription use in the United States, as another means for women to prevent unintended pregnancy.

Dr. Imershein is an obstetrician/gynecologist who has practiced in the Washington, DC, area for more than 25 years. She treats many women who rely on emergency contraception as a backup when their regular birth control fails. In her testimony, included below, Dr. Imershein praises the introduction of a new option for women in need of emergency contraception, and calls on the FDA to conduct a fair and unbiased review of ulipristal acetate.

“Good afternoon and thank you Dr. Carson and members of the Committee for granting me this time to speak. My name is Dr. Sara Imershein. I am here today representing Physicians for Reproductive Choice and Health, a doctor-led national advocacy organization. I am a board certified ob/gyn and have been providing comprehensive reproductive health care to my own patients in the Washington, DC area for over 25 years.

“Physicians for Reproductive Choice and Health welcomes the development of a new, safe, and effective form of emergency contraception, ulipristal acetate.

“Unintended pregnancies can create crises for women, with a ripple effect on their families and friends. These crises are all too common and come with a high price tag for women and our country. As physicians, our goal is to help women avoid unplanned pregnancy. Every day, I help patients plan the families they desire and reach their full potential.

“Every patient is unique. Physicians like me rely on a variety of contraceptive methods to meet each woman’s personal needs. For women who need an emergency contraceptive, our current options are few. I am pleased to see the development of such an important advance in women’s health: ulipristal acetate. We know that more emergency contraception options will improve our care for women in these crisis situations. We look forward to more in-depth studies comparing ulipristal acetate to other forms of emergency contraception, to guide our selection of the best method for each patient.

“As physicians, we know that birth control can fail, because we see patients often who are pregnant despite their best efforts to use contraception.

“Let me tell you about my patient, Karen, who relied on birth control pills, a method that worked for her and her husband. They were leaving on a two-week business trip abroad, and Karen knew that her current pack of pills would run out while they were overseas. She went to the pharmacy to get an advance pack of pills. The pharmacy turned Karen down, explaining that her insurance plan would not cover an advance prescription. She would have to wait until she was within a day of running out—by then, she and her husband would be far from home.

“While away, Karen used up her pills, and she and her husband switched to condoms as a back-up method. But a condom failed (it broke). Karen called me as soon as she returned, and I immediately recommended an emergency contraceptive—likely averting a pregnancy.

“For Karen and so many other women’s sake, I hope that this new medication will be readily available soon to patients who need it. It is especially important for women to access this time-sensitive medication when they need it. We hope that an increased number of emergency contraceptives will help keep down the costs and make this medication affordable. Further, we encourage you to trust physicians to prescribe this medication appropriately—without the need for special labeling, pregnancy testing, or other burdens that create barriers for women trying to prevent pregnancy.

“Finally, we expect that the review process for this medication will be consistent with the standard FDA procedures based on science and evidence, to the exclusion of political and ideological perspectives. In the past, such barriers have impeded women’s access to reproductive health medications, specifically emergency contraception. We urge the committee to ensure the review process for ulipristal acetate will not suffer the same problems.

“Our focus as physicians is on the health of American families. We strive to provide patients with quality, comprehensive, reproductive health care that meets the needs of women and their families. We know you share these goals, and we hope you recognize that this new emergency contraception is crucial to our success.

“Thank you.”

DR. IMERSHEIN AVAILABLE FOR COMMENT

Contact: Amanda Davis; 646-649-9927; 646-334-1388 (cell); amanda@prch.org

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Physicians for Reproductive Choice and Health is a doctor-led national advocacy organization. We use evidence-based medicine to promote sound reproductive health policies. We believe in reproductive choice for everyone.