My name is Christina Cherel, and I am the Program Coordinator at the National Women’s Health Network. The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. We are supported by our members and do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.
Since the Network’s founding 40 years ago, we have brought the voices of women to the FDA, advocating for medical products that meet women’s real life needs and a drug development process that reflects women's lived experiences.
One of the guiding values of the National Women’s Health Network is that with the right information, all women can make good decisions about their health care. This could not be truer than with regards to women’s sexual and reproductive autonomy, which includes using hormonal contraceptives. Being able to space, plan, and prevent pregnancy is vital to women’s health. When something interferes with women’s ability to successfully manage her fertility, such as drug interactions that reduce the efficacy of her hormonal contraceptives, it is imperative that the public health community do what it can to better understand and resolve these issues.
We are pleased to have the opportunity today to comment on the topic of drug interactions with hormonal contraceptives. The Network has been an advocate for the provision of accurate and useful information about hormonal contraceptives for over 40 years and as such, we respectfully submit the following for consideration by the FDA.
Women must know if they are likely to experience adverse drug-drug interactions or decreased efficacy of their hormonal contraceptive as a result of using certain drugs. Investigating the possibility of drug-drug interactions with hormonal contraceptives should not be discretionary. FDA regulations should make it clear to sponsors exactly what kinds of studies are required, and when information from those studies must be made available to women. Without this crucial information, women are at a severe disadvantage when it comes to deciding which, if any, drugs to take. There are many classes of prescription and over-the-counter drugs which do not decrease the efficacy of hormonal contraceptives. For those that do, however, it is imperative that women are able to access and understand this information.
Today’s scientific workshop will include discussion of multiple topics related to drug interactions with hormonal contraceptives and I will comment on designing drug interaction studies and translating the results from these studies into labeling. I also realize that the agency will discuss clinical practice and communication later today, which is of particular interest to the Network. Both receiving and understanding this information are important for women in order to make meaningful decisions about their health care.
With regard to study design and interpretation, evaluating a new drug’s effect on hormonal contraceptive efficacy and adverse reactions cannot be considered an afterthought, or something that can be tested solely in post-market studies. Drug sponsors must build into their initial study design a rigorous analysis of the drug’s possible effects on hormonal contraceptives efficacy. Furthermore, studies must be done on various formulations (combined estrogen and progestin vs. progestin only) and types (oral contraceptive pill vs. hormonal IUD) of hormonal contraception. The FDA should not grant approval to drugs that have not completed this analysis, even if a sponsor promises to complete the study post-approval. For example, a recent analysis showed that only 13% of post-market studies on high risk devices were completed within 3-5 years. Women need information as soon as a drug is approved, not promises that might never be fulfilled.
This issue continues to be a pressing problem. Just three months ago, the FDA approved flibanserin, a drug intended to treat Hypoactive Sexual Desire Disorder in premenopausal women. Prior to approval, the drug’s sponsor did not adequately evaluate possible exacerbation of the adverse effects of flibanserin by hormonal birth control. The sponsor also failed to evaluate whether flibanserin might make a woman’s birth control less effective. Given that this drug is supposed to increase a woman’s desire for sex, it would seem really important to know whether the drug may diminish the efficacy of a woman’s hormonal contraceptive. The sponsor, however, failed to conduct this analysis and now women are forced to make decisions without this vital information and play guesswork when it comes to their health. Both the FDA and the drug sponsor must be held accountable for these all too often inconsistent and incomplete evaluations of new drugs.
With regard to improving labeling, the Network suggests making labels as clear, concise, and truthful as possible. For example, including on the label some of the following text may help improve consumer understanding of drug labels:
“Patients should be advised that in some cases, [insert drug name] has been shown to decrease the ability of hormonal birth control (including [insert specific formulations]) to prevent pregnancy. This means that if you rely on hormonal birth control to help prevent pregnancy, you are encouraged to use alternative methods of non-hormonal birth control (including condoms, spermicide, or diaphragm) while taking this drug.”
This language will ensure women understand the decreased efficacy of their hormonal contraception as well as offer them alternative options for preventing pregnancy while using a particular drug. In addition, prescribers should be as forthright as possible about the ability of hormonal contraceptives to make adverse effects of certain drugs more common, or decreased efficacy in a woman’s choice of hormonal contraceptive when used concurrently with other medications.
We implore drug sponsors and the FDA to do the right thing - and give women the crucial information they need to make the health care decision that is right for each of them. Thank you.
The National Women’s Health Network is supported by our members and by choice, we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.
Christina Cherel, MPH, is a women’s health advocate and former NWHN Policy & Advocacy Manager. Currently, she advocates globally for reproductive health research as Program Officer for the Bill & Melinda Gates Institute and as Communications Chair for the International Conference on Family Planning.