The US Food and Drug Administration (FDA) is considering approval of a first of its kind over-the-counter oral contraceptive pill, submitted by two organisations that are campaigning for its acceptance. But looming changes in policy, coverage and patient protection could provide barriers to its access and use.

The move to get oral contraceptive pills (OCP) over the counter has long been supported by several reproductive health organisations through the Oral Contraceptives (OCs) Over-the-Counter (OTC) Working Group, a coalition of non-profits, clinicians, reproductive health advocacy groups, universities and the likes. This campaign is also supported by the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians (AAFP) and the American Medical Association.

The two groups submitting the proposal are Ibis reproductive health and HRA Pharma. Ibis’s campaign, freethepill, not only advocates for this but seeks to educate people about the consequences of this move on reproductive health. Ibis is also advocating simultaneously for pharmacist prescription of the pill in more states. Currently, a few states such as Colorado, Maryland, Hawaii, California, Oregon and New Mexico authorize pharmacists to prescribe the pill. A few other states – Missouri, Minnesota, New Hampshire and Illinois – are considering legislative moves in this arena.

Many reproductive organisations are not only pushing resolutions for over the counter access but are also looking to increase coverage regardless of insurance plan, increase access without physician prescription, authorize pharmacist prescription of OCPs in more states and prevent age restriction to over the counter pills. Ibis also offers resources to women who are not insured or do not have access to a physician to obtain pills through some online prescription agencies.

So, what does this mean for policy, coverage and patient protection? Currently women insured under Obamacare and most private insurance plans can get the pill at no cost. However, this might not be the case for long. With the current administration in place, threats to funding for OCPs exist. Title X funding changes as well as efforts to dismantle Obamacare could make it harder for women to buy oral contraceptive pills at a nominal fee.

This is further fuelled by pharmacist refusals to dispense OCPs. Pharmacies in over 26 states have been known to deny dispensing OCPs based on religious and personal beliefs. In this case, the pharmacist usually transfers the prescription to another pharmacy. This may prove to be consequential for women’s health if the other pharmacy is either geographically out of reach, does not accept the patients existing insurance plan or does not hold stock of that particular medication.

The law for pharmacists dispensing also varies in different states. States such as Alabama, Delaware, New York, North Carolina, Oregon, Pennsylvania, and Texas allow pharmacists the right to refusal whereas other states such as California, Illinois, Maine, Nevada, New Jersey, Wisconsin, Washington and Massachusetts mandate that pharmacies dispense medications to the patient.

In 2015, the Allowing Greater Access to Safe and Effective Contraception Act (HR 421) was introduced by Republican representative Mia Love from Utah, to allow for special incentives for pharmaceutical companies to file over the counter oral contraceptive pill applications with the FDA, with a caveat that this access would only be restricted to women 18 years and above. However, there is very little guarantee that the price of the over the counter pill will be affordable.

Even if the over the counter pill is approved, it is possible that administrative cuts to Obamacare, coverage rules of contraceptives under generic insurance plans, Title X defunding, pharmacist prescribing protection laws as well FDA regulatory changes could find ways to prevent nationwide access to the first of its kind over the counter contraceptive pill.

Image Credits: Ibis reproductive health.