A few years ago, after learning she had high blood pressure, Shannon Connell-Robicaud asked her doctor to change her prescription for the birth control pill. She had read that the pill she was given put people around her age with the condition at high risk of stroke.
The doctor agreed, she said — but only after Ms. Connell-Robichaud, a 32-year-old paralegal, shared a list of the blood pressure readings she’d taken on her own. After that, she recalled, the doctor said, “Hey, maybe you’re right.”
The question of whether women can control their own health risks when taking birth control pills is at the heart of a debate now raging in the pharmaceutical industry and the Food and Drug Administration: Should oral contraceptives be made over-the-counter rather than prescription?
Although taken by millions of people, birth control pills can interact with certain medical conditions in ways that have always placed them in the prescription category, meaning that a doctor’s supervision is required.
In effect, if the FDA approves an over-the-counter version, it will say that women with underlying health risks who choose that option should do their own research on how the birth control pill would interact with their condition and other medications they take.
Reproductive rights activists in the United States view an over-the-counter birth control pill as a simple and effective tool for rural, poor and historically marginalized communities to prevent unwanted pregnancies — by reducing their barriers to health care and decreasing abortion rates. the route.
At least two drug companies want to file an application with the FDA to switch to an over-the-counter version and have communicated with the agency about their plans. But after years of preliminary trials to overcome the agency’s research and consumer testing hurdles, neither has reached the filing stage.
The FDA defenders say that by asking lots of questions and demanding rigorous testing, the agency is cautious about assessing the potential health risks of making the pill available without a prescription.
But frustrated supporters of the switch are critical of the agency’s lengthy pre-application process — which requires FDA approval at certain points to proceed to the next stage. Some of them see the process as an obstacle to advancing reproductive rights, as well as a case study of the costs when the FDA takes an overcautious approach. (The agency has also been criticized in other drug approval cases for acting too quickly, such as when it accelerated approval of a controversial Alzheimer’s drug earlier this year.)
Proponents of allowing over-the-counter access say they are looking at the issue with greater urgency as the Supreme Court reconsiders the constitutional right to abortion, as established by Roe v. Wade in 1973.
The move to improve access to birth control pills “is something that gives a little bit of hope in these days when it feels like we’re under constant attack,” Monica Simpson, executive director of the reproductive rights organization SisterSong, said in a webinar late last year. September.
Oral contraceptives are already the most popular non-permanent method of contraception in the United States and are sold without a prescription in numerous countries, including the United Arab Emirates, China and Mexico.
Nearly $3 billion worth of prescription birth control pills are sold in the United States each year, according to the life sciences research firm Iqvia. They are manufactured by several pharmaceutical companies, including Pfizer Inc. and Bayer AG.
Pressure to approve an over-the-counter option comes primarily from two smaller players: Cadence Health, which plans to file an application on behalf of its oral contraceptive, Zena, and from HRA Pharma, a small drug manufacturer based in Paris.
Research shows that birth control pills are safer than pregnancy itself, which carries a higher risk of blood clots, among other health problems.
“We want to make it safe. We’re not trying to cut corners at all,” says Dr. Nap Hosang, the obstetrician and gynecologist who is co-chief executive of Cadence Health.
But the process is progressing slowly and the FDA, which has been in talks with both Cadence and HRA Pharma since 2016, has yet to be convinced.
HRA Pharma completed its final testing phase this year, known as the ‘real-use trial’. It is expected to file a formal application for over-the-counter approval next year.
But the FDA put a brake on the actual use of Cadence about a year ago. It has asked the company to consider adding new warnings and additional details to existing warnings on the drug safety label, and to repeat some tests for over-the-counter use.
Cadence officials say they are frustrated by the delay. But one factor that can counteract Cadence is that Zena is a so-called combination pill, meaning it contains both estrogen and progestin, while HRA Pharma’s pill contains only progesterone.
Combined pills such as Cadence’s account for 90 percent or more of oral contraceptives sales overall because they are less likely to cause unscheduled bleeding and require less vigilance on the part of patients to take them at the same time each day. But they also pose greater safety risks for some women, including those with high blood pressure or clotting problems, than their progestin-only counterparts, such as the HRA Pharma Pill.
“The feeling I’ve been getting, and it sounds like you’ve heard the same thing, is that the FDA has more questions about bringing a combination pill over the counter,” says Dr. Susan Wood, professor of health policy at George Washington University. She resigned as director of women’s health at the FDA in 2005 because of what she considered unreasonable delays in approving over-the-counter use of the drug Plan B, which prevents pregnancy after unprotected sex.
“I don’t think they’re political, I think they’re just being careful,” she said. “They have to consider safety in an OTC environment,” which is different from safety in a prescription-only environment, she added.
Yet say Dr. Wood and other past participants in the FDA transition process who have spent five years or more in dialogue about drug testing and safety materials before even requesting a switch to over-the-counter availability — as Cadence and HRA Pharma have — have been a remarkably long time.
The FDA declined to answer specific questions about Cadence and HRA Pharma, but said it aims to make a decision within 10 months once a company applies for approval to transition from prescription to over-the-counter status. “The amount of time a company spends on its development program before applying for a prescription-to-nonprescription switch is determined by the company, not the FDA,” an agency spokeswoman said in a statement.
The two companies see it differently. They say they have sought the FDA’s blessing in their preparations – and in some areas are required to get it in order to proceed. “We need to get their permission to move to the next step in development. And we don’t have their permission,” said Samantha Miller, Cadence’s co-chief executive.
The FDA’s over-the-counter switch option is appealing to some drug companies because the first drug in its class to be ported could gain three years of market exclusivity, giving it a temporary monopoly on over-the-counter sales. That advantage is one of the reasons why the larger Dublin, Ireland-based pharmaceutical company Perrigo announced plans to acquire HRA Pharma earlier this year.
To varying degrees, both HRA Pharma and Cadence Health are involved in outside efforts to convince the FDA to agree to their plans. While HRA Pharma has been publicly silent about its interactions with the agency, it has been working closely with a research and advocacy group pushing the agency to approve an over-the-counter option. And Cadence is counting on women’s health care providers and public health officials to try to make the agency look more favorably at its planned application.
Last year, Cadence hired Dallas-based consultant Rania Batrice, a deputy campaign manager for Senator Bernie Sanders during his 2016 presidential campaign, to advise him on political strategy.
Ms. Batrice has urged lawmakers such as Representative Barbara Lee, the California Democrat who co-chairs the Congressional Pro-Choice Caucus, to ask the FDA to join a panel of medical experts to discuss the idea of a switch to over-the-counter. the- counter status for Zena.
“Access to over-the-counter contraception is an issue of racial equality, an issue of gender equality and an issue of economic equality,” Ms Lee said in a statement. “In the same way that other methods of birth control are available without a prescription, so should the Pill.”
Ms. Batrice has also worked with grassroots organizations such as the Indigenous rights group NDN Collective and the New American Leaders Action Fund to spread the word that over-the-counter access to a drug like Zena would benefit rural residents, people of color and others with disabilities to the healthcare.
But Cadence executives say approval for Zena will likely be in at least two years — if they’re successful at all with the FDA
“We’ve discussed and agreed on so many issues with this FDA over the past five years,” said Ms. Miller. “Right now there are really some challenging issues that can prevent a successful OTC switch.”
Among them is opposition from anti-abortion groups such as the Family Research Council and the American Association of Pro-Life Obstetricians and Gynecologists, who say that decisions about women’s reproductive health should be made in consultation with a doctor. And some women say they’re not sure whether the drugs should be available over the counter without going through a doctor or pharmacist.
“I know so many people who don’t read the box, don’t pay attention,” said Jordan de Jongh, a 28-year-old data entry worker in Houston who uses oral contraceptives. “So I saw a teenage girl access contraception at a pharmacy without having to tell her super-religious parents; that is amazing. But I could see a girl taking five pills and thinking she wasn’t going to get pregnant from sex last night; that’s a myth.”