Regulatory approval time for hormonal contraception in Canada, the United States and the United Kingdom, 2000-2015: a retrospective data analysis

Abstract

Background: Access to a wide range of contraceptive methods improves prevention of unintended pregnancy by ensuring the best method fit for each individual. We compared approval times of new hormonal contraceptives by Health Canada, the US Food and Drug Administration (FDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Methods:We obtained dates of applications to Health Canada, the FDA and the MHRA for contraceptive methods approved from January 2000 to January 2015. We used public data sources and direct correspondence, and excluded generic versions of previously approved drugs. The primary outcome of interest was median time to approval for novel hormonal contraceptives. Secondary outcomes included the median time to approval for all hormonal contraceptives and the number of approved hormonal contraceptives comparing countries studied, as well as the median time for approval of novel compared with nonnovel hormonal contraceptives within each country.Results: During this period 16 contraceptives were approved in Canada, 26 in the US and 14 in the UK. Applications for novel contraceptives were initiated later in Canada, and time to approval was longer in Canada than in the US (p = 0.03).

Induced abortion according to immigrants’ birthplace: a population-based cohort study

“…A known barrier in the Canadian context, is that immigrants residing in Ontario for as long as 10+ years have lower access to enhanced primary care models, particularly those which are patient-centered, comprehensive, coordinated and continuous [12,35] which make effective contraception counseling and ongoing family planning less accessible. Finally, due to regulatory barriers, access to long-acting reversible contraceptives (LARCs) specifically all types of subdermal implants and many types of intrauterine devices (IUDs) are not available in Canada [36,37]. IUDs that are available have large upfront costs and require and appointment with a doctor trained in insertion as well as time off work for the procedure and to rest.…”

“…Improving availability and access to high-quality, professional interpretation [43,44] is also important. Overcoming regulatory barriers to LARCs [38] and providing a universal contraception subsidy [36,37], given the high costs of contraception and the high proportion of immigrants with low incomes, may increase opportunities for immigrants to access and utilize contraception that best suits a variety of needs and circumstances. Finally, improving immigrant's access to high quality primary care [12] is critical to establish and enable ongoing contraceptive counseling and family planning.…”

Reasons for hormonal contraceptive use in a cohort of African-American women living in the Detroit area

“…At least 80% of African-American women are ever users of HCs [3], and approximately 20% were currently using HCs in 2006-2013 [1,4]. In the 1990s and early 2000s, the U.S. saw a dramatic increase in the number of available HCs, from the initial approvals of implantable and injectable contraceptives (referred to as long-acting reversible contraceptives, or LARC) to the introduction of the patch and the ring [3,5]. In this new context, contraceptive selection is related to convenience, cost, side effects, peer utilization, and awareness of method [6,7], and many women try more than one HC route in their lifetime [3].…”

Trends and determinants of postabortion contraception use in a Canadian retrospective cohort

“…Intrauterine devices (IUDs), including copper intrauterine devices and levonorgestrel-releasing intrauterine systems, are a form of longacting, reversible and highly effective contraception [1]. In Canada, no other long-acting reversible contraceptives, such as contraceptive implants, are currently available [2,3]. When provided immediately after abortion, IUDs have been shown to reduce subsequent abortion rates [4][5][6][7][8][9].…”