PUBLIC HEARING COMMENTS BEFORE THE FDA ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS:
New Drug Application (NDA) 22-474, Ulipristal Acetate Tablets (30 mgs) – ?Ella? Emergency Contraceptive
For over 30 years, NHeLP, a national public interest law firm, has sought to improve health care and protect the right to health for America?s low-income populations, communities of color, women, and other uninsured or under-insured communities, with our primary emphasis on working to support the Medicaid program and other safety-net programs through legislative and policy advocacy, technical support, and class action litigation.
On behalf of NHeLP, thank you for the opportunity to present comments regarding the accessibility of FDA-approved contraceptives for low-income populations. I request that my written comments and supporting materials be submitted as part of today?s public hearing record.
I. Background Information and Issue:
- Family planning is essential to maintaining women?s health (particularly the health of women with low-incomes and health disparities), which is negatively impacted by untimely access to family planning information and supplies. This impact is felt by the 17.4 million low-income women who were considered to be in need of publicly funded contraceptive services and supplies (e.g., covered through Medicaid or provided in Title X family planning clinics), [according to the Guttmacher Institute, 2008].i Family planning is also featured as a focus area of the Healthy People 2010 health promotion objectives, established by the U.S. Department of Health and Human Services (HHS).ii
- The outcome of untimely access to contraceptives and family planning information is reflected in significant and troubling rates of sexually transmitted diseases, unintended pregnancies, and poor health and birth outcomes for women with chronic diseases and health disparities.iii For example:
- For women with chronic health conditions, such as diabetes, cardiovascular disease, epilepsy, and lupus, it is particularly important for them to use effective contraceptive methods to prevent pregnancy until their chronic condition can be controlled [Centers for Disease Control and Prevention, Recommendations to Improve Preconception Health and Health Care, 2005].iv
- The scope of health disparities is further demonstrated by examining prevalence rates of type 2 diabetes. All minorities (except Alaskan Natives) have a two to six times greater prevalence rate than that of the white population for this disease. [HHS, Agency for Healthcare Research and Quality].v
- The primary issue of concern is the following current requirement: For states to obtain federal reimbursement, the Medicaid program requires a prescription for family planning drugs and supplies that are typically sold over-the-counter (OTC), including condoms, spermicides, and other OTC products. If the FDA approves the current new drug application (Ella) as an emergency contraceptive (EC), and eventually for OTC use ? like its predecessor Plan B® (levonorgestrel) ? millions of women would have increased access to an additional important contraceptive, except for low-income women. Specifically, Medicaid beneficiaries are currently subject to the prescription requirement in order to get OTC products, which would effectively delay and often block OTC access to Ella and other contraceptives.vi
- The prescription requirement adds costly and unnecessary provider visits, and creates barriers to OTC family planning drugs and supplies for Medicaid beneficiaries (who cannot afford to pay out-of-pocket costs for contraception), which results in unequal access to contraception and other prevention efforts for low-income communities.
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