Testimony Presented to the United States Food and Drug Administration’s Advisory Committee for Reproductive Health Drugs

Testimony Presented to the United States Food and Drug Administration’s Advisory Committee for Reproductive Health Drugs
June 17th, 2010

My name is Dr. Beth Jordan. I am a women’s health specialist and medical director of the Association of Reproductive Health Professionals. ARHP was founded in 1963 and is an international professional association whose members include physicians, advanced practice clinicians, researchers, educators, and advocates, all with expertise in reproductive health research, practice, or policy.

On behalf of ARHP and its 12,000 members, I’m pleased to provide comments before the Food and Drug Administration’s Advisory Committee for Reproductive Health Drugs.

For purposes of disclosure, ARHP is a 501c3 non-profit organization and is supported by unrestricted educational grants from foundations and companies. We also receive individual donations from those interested in supporting evidence-based research and education. Pursuant to this committee meeting, ARHP has not received current or past grants from either HRA Pharma or Watson Pharmaceuticals, Inc.

ARHP translates good science and into excellence in clinical practice by producing ACCME-accredited, evidence-based, peer-reviewed continuing education programs for health care professionals across a broad range of RH topics. ARHP members are passionate about science and demand rigorous standards for peer-reviewed data in educational programs and integrity in patient care. ARHP advocates for evidence-based research and supports the availability of a wide range of safe, effective contraceptive options for women.

ARHP is pleased that the FDA is reviewing the application for ulipristal acetate, or ella, and supports the approval of this product as an additional safe and effective contraceptive option for women.

Choosing when and whether to become a parent is one of the most important issues women face during their childbearing years. Contraception is not always effective and not all sex is protected, or sadly, even wanted. Emergency contraception provides women with the crucial opportunity to prevent unintended pregnancy after contraceptive failure or unprotected or unwanted sex. Access to emergency contraception is an essential part of ensuring comprehensive family planning options.

Evidence demonstrates that ella is safe and effective at delaying ovulation for five days, particularly during the time when women have the highest chance of becoming pregnant.

Women need contraceptive options that are appropriate, accessible, and affordable. If approved, ella will join other currently available emergency contraceptive products in the US and will offer yet another choice to women. Having more than one available option—one with and one without a prescription—provides women with further opportunities to prevent unintended pregnancy.

In summary, ella is a highly safe and effective product that will give women an additional option for preventing unintended pregnancy. For these reasons, ARHP respectfully urges the committee to move forward with the approval process for ella. And we hope that the review process is consistent with standard FDA procedure and is based firmly on the safety and efficacy of this emergency contraceptive product.

I would like to thank the committee for the opportunity to discuss this important issue.