FDA’s outdated Birth Control Guide blocks access to the innovations the agency has approved

Every day, women in the United States are routinely denied access to the latest birth control methods approved by the Food and Drug Administration.

The reason for this may seem unfathomable in a nation so deeply reliant on instant access to the latest information: Health insurers deny covering new contraceptive methods because a single page on the FDA’s website — its Birth Control Guide — fails to include the new and innovative products the agency has spent time and energy reviewing and approving.

Recognizing the importance of contraception to women’s health, the FDA originally created its Birth Control Guide to fill a void in consumer-focused contraceptive information and to provide a resource for women by outlining their contraceptive options. It was a valuable compilation when it was first published during my tenure as director of the FDA’s Office of Women’s Health in the late 2000s. But the guide hasn’t been substantively updated in recent years, and does not include information on newly approved birth control methods or significant modifications to previously approved methods.

For years, there was relatively little innovation in contraception, leaving many women unhappy with — or unable to use — the options available to them. But since 2018, the FDA has approved several new and novel contraceptive methods such as Annovera, a vaginal contraceptive ring that is replaced each year; Twirla, a low-dose transdermal contraceptive patch; and Phexxi, a nonhormonal, on-demand contraceptive vaginal gel.

These new contraceptives would be welcome news to women seeking alternative options, except many women lack access to them because they are not covered by many health insurance plans by dint of their not being included in the FDA’s Birth Control Guide.

The Essential Health Benefits of the Affordable Care Act (ACA) and regulations from the Department of Health and Human Services (HHS) require insurers to cover preventive services and screenings for women as defined by the Health Resources and Services Administration (HRSA). HRSA’s guidance calls for all women to have “access to the full range of contraceptive methods” that are “currently identified by the U.S. Food and Drug Administration.”

And therein lies the problem.

At the time the ACA was implemented, no comprehensive regulatory document existed for contraceptive coverage. So federal agencies, health insurers, and pharmacy benefit managers turned to the FDA Birth Control Guide as formal guidance. Coverage has been determined this way ever since, even though the guide is out of date.

By not updating the Birth Control Guide in lockstep with the new contraceptive methods it approves, the FDA is allowing health plans to deny coverage for these innovative products even when they may be the most suitable options for women’s unique health needs and preferences.

Some women find it difficult to remember to take a daily pill. Some don’t want to have to go to a clinician to have an IUD inserted. Others have medical concerns or experience adverse effects such as mood changes, abnormal bleeding, or even cardiovascular or cancer risk that keep them from using other commonly accessible options or using hormones of any kind.

An added problem is that when a new product or treatment isn’t covered by a health plan, the insurer typically requires a “fail first” process to avoid, or at least delay, coverage of a new, sometimes more expensive product. This means a woman must first try several older products — and those products must “fail” — before her insurer will authorize coverage of the new product or therapy. But “failure” in the case of birth control frequently translates to unintended pregnancies — which remain a significant public health issue in the U.S.

The FDA needs to step up to the plate.

The issue with updating and maintaining the Birth Control Guide can largely be attributed to silos throughout the federal government. It is likely that agencies failed to inform each other of the intent and appropriate uses of the guide, allowing a document created for consumers to be used by insurers as a determinant of coverage. If the FDA, HHS, and HRSA were to agree on how crucial an up-to-date Birth Control Guide is to reproductive health, there might well be a more concerted effort to ensure understanding about the ownership of the Birth Control Guide and the process for updating it.

Some recent action in Washington has aimed to bring attention to this disservice to women. In late June, the House Appropriations Committee approved the FY2022 Agriculture, Rural Development, FDA, and Related Agencies Funding Bill. In the bill’s report, the committee called on the FDA to “update its Birth Control Chart and website to reflect new products that have entered the market” in the past decade. After hearing reports of insurance coverage denials, four House committee leaders urged the Biden administration to ensure that insurance companies cover all FDA-approved contraceptives — even if they aren’t included in the FDA’s Birth Control Guide. Influential advocacy organizations, such as the National Women’s Law Center, have also joined the effort to improve access to approved contraceptive methods.

The solution is clear and simple: To help meet women’s preventive health and wellness needs, the FDA — in tandem with other federal agencies — must routinely and comprehensively update the contraceptive methods listed in its Birth Control Guide to reflect the latest FDA-approved innovations. Every day that the information in this guide remains incomplete is a day the agency is failing public health and the health of women in the U.S.

Kathleen “Cook” Uhl is a physician trained in family medicine and clinical pharmacology who served as the director of the FDA’s Office of Women’s Health from 2005 to 2010 and then as the director of the Office of Generic Drugs from 2013 to 2019. She is currently a pharmaceutical consultant at UHL Consulting LLC and is also a consultant for Real Chemistry. The opinions expressed here are hers alone, based on her 20-plus-year career working at the FDA, and do not necessarily reflect those of the companies with which she is affiliated.