September 08, 2020
The Honorable Kaveeta Vasisht, MD The Honorable Lowell Schiller, JD
Associate Commissioner for Women’s Health Principal Associate Commissioner for Policy
U.S. Food and Drug Administration U.S. Food and Drug Administration
Room 2322, White Oak Building 32 Room 4300 White Oak Building One
10903 New Hampshire Avenue 10903 New Hampshire Avenue
Silver Spring, MD 20993 Silver Spring, MD 20993
Re: [Docket No. FDA-2020-N-1391] Comments on Office of Women’s Health Strategic Priorities
Thank you for the opportunity to comment on the strategic priorities for the Office of Women’s Health (OWH). We appreciate the critical role that OWH plays in ensuring that women’s needs are represented across FDA and in the agency’s research, education, and public outreach.
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 concerns and needs of women consumers to policy and regulatory tables. Since the NWHN’s founding 45 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.
The NWHN lobbied Congress for the creation of the FDA Office of Women’s Health in 1994 and for its incorporation into the Affordable Care Act in 2010. We opposed reorganizational efforts that would have neutered its influence within the agency. And we have long worked with OWH on questions of clinical trial diversity, research priorities, and scientific integrity in reproductive health. We recognize the tremendous value of OWH in speaking up for women.
Promoting Scientific Integrity in Reproductive Health Decisions
Historically, women’s reproductive health products have been subject to outside political pressure, from the well-documented delay of over-the-counter access for levonorgestrel emergency contraception (Plan B) to the recent approval of flibanserin (Addyi), an ineffective and potentially dangerous drug for female sexual desire.
We applaud OWH’s long history of providing leadership when FDA and advisory scientists have encountered political or ideological pressures on products related to women’s reproductive health. While we know that OWH is not involved in making decisions about individual products, we urge you to continue prioritizing your role as a champion for scientific integrity as FDA considers:
- OTC applications for certain emergency oral contraceptives and daily oral contraceptives,
- applications for new contraceptive drugs and devices,
- applications for new female libido drugs and devices,
- a reassessment of the Risk Evaluation and Mitigation Strategy (REMS) imposed on mifepristone,
- guidance about any of the products mentioned above,
- and more.
In particular, we urge OWH to support a full reassessment of the mifepristone REMS and associated Elements to Assure Safe Use (ETASU), which pose a significant barrier to care without providing any countervailing health benefit and which drive some pregnant people to seek less safe or less effective alternatives.
Under the current ETASU, pregnant people may undertake every part of the medication abortion process at home — from conducting their consultation remotely to taking their pills at a time and place of their own choosing — but must first travel to pick up mifepristone in person. For many women, mandatory in-person dispensing requires them to take off time from work (on the clinic’s schedule), arrange childcare, arrange for transportation, travel long distances, pay for travel costs, and endure threats and harassment from clinic protesters. Any one of these barriers can significantly delay a pregnant person’s ability to access timely care.
Additionally, as noted in American College of Obstetricians and Gynecologists et al v. FDA, “Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer, unsupervised, at a location of their choosing.” To date, FDA has not provided any explanation for how a mandatory travel requirement assures safe use despite the myriad attendant delays such a requirement can impose. Nor has FDA explained why that rationale applies only to mifepristone when used to induce abortion and not to any other drug regulated by the agency, nor even to mifepristone when used daily in much higher doses to treat Cushing’s syndrome.
Furthermore, in-person dispensing forces providers who want to offer mifepristone to serve as their own mini pharmacy, pre-purchasing the pills and keeping them in stock in their office or clinic. One study found that “the number of ob-gyns providing medication abortion might at least double if they could write a prescription for mifepristone” for patients to receive by mail or pick up at retail pharmacies instead of having to stock it on their own.
This regulatory incoherency is even more stark when considered next to the unintended consequences of FDA’s mifepristone policy: the obstacles, costs, and delays associated with the ETASU are leaving many women with little choice but to turn to online pharmacies outside of FDA’s regulatory umbrella or to other methods that may or may not be as safe and effective as the FDA-approved mifepristone-misoprostol regimen.
While we recognize that OWH cannot make decisions on the mifepristone REMS, we urge OWH to prioritize support for a full reassessment and to highlight ways in which current rules are doing more harm than good.
Despite the well-documented dangers of breast cancer, stroke, blood clots, cognitive decline, gall bladder disease, incontinence, and more posed by menopause hormone therapy, some drug-makers and providers continue to push women toward “replacement” therapies that may do them more harm than good. Many of the public comments submitted to this docket thus far are indicative of the appetite for hormone therapy but not a clear understanding of the dangers they pose or their limited efficacy. We urge OWH to include education on the risks of hormone therapy in its public outreach efforts.
We also urge OWH to support stricter regulation of compounding pharmacies and the labeling and marketing of compounded medications in order to ensure that consumers can make informed choices about hormone therapy. In particular, we are concerned by the common practice of describing “bioidentical” hormones as “natural,” which misleads consumers and provides a false sense of safety. This confusion around terminology is significant from a regulatory perspective because women who purchase compounded hormones to avoid “synthetic” or “pharmaceutical” hormones are in fact often using exactly the same synthetic pharmaceutical hormones. Until proven otherwise, the most reasonable course of action is to assume that these risks are associated with both FDA-approved hormones and compounded hormones, and the OWH should support regulation that would ensure prospective patients are made aware of this important safety information.
Public Update on Status of FDA’s Section 907 Action Plan for Clinical Trial Diversity
Section 907 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) directed FDA to create an action plan to improve the representation of demographic subgroups in clinical trials and to make that data easily accessible to the public. The last significant public review of the status of the Action Plan took place in February 2016. At the time, we praised the agency for progress made but raised concerns about an agenda focused on precision medicine that seemed to suggest FDA was making a philosophical move away from ensuring that women, people of color, and the elderly are appropriately represented in clinical trials for new drugs and medical devices.
As we said then, sex, race, ethnicity, and age are now—and will be for years to come—the best proxies we have for determining how widely used drugs and medical devices are likely to affect certain individuals. The failure of industry to adequately test the efficacy and safety of a new drug or device on these demographic subgroups cannot be swept under the rug in the hopes that new technology will make such study unnecessary at some point in the future.
Since then-Commissioner Califf gave his opening remarks on “The Shifting Paradigm and FDA’s Current Thinking” more than four years ago, three additional commissioners have led FDA and many of the links on the FDA’s Action Plan web page are now broken. We urge OWH to prioritize holding another public meeting on the progress made toward completing the Plan’s intermediate- and long-term goals and to ensure that information about the Plan is accessible to the public on the website.
Expansion of Drug Trial Snapshots to Include Medical Devices
Perhaps one of the most visible successes of the Action Plan to date has been the creation of Drug Trial Snapshots, which provide consumers with critical, easy-to-read information about clinical trial diversity for new molecular entities and original biologics. We urge OWH to push for an expansion of Snapshots to include information for medical devices, both new and already on the market, as well as for previously approved drugs.
For more than two decades, the OWH has proven invaluable for responding to consumer concerns and funding critical research. Thank you for the opportunity to provide input into OWH’s priorities.
Policy Advocacy Director
National Women’s Health Network