Push to make birth control available over the counter
FDA being urged to drop required prescription
A few years ago, after learning she had high blood pressure, Shannon Connell-Robichaud asked her doctor to switch her birth control pill prescription. She had read that the pill she had been prescribed put people around her age with that condition at high risk of a stroke.
The doctor agreed, she said — but only after Connell-Robichaud, a 32-year-old paralegal, shared a list of the blood-pressure measurements she had been keeping on her own. After that, she recalled, the doctor said, “Hey, maybe you’re right.”
The question of whether women can monitor their own health risks in taking birth control pills is at the heart of a debate now playing out in the pharmaceutical industry and at the Food and Drug Administration: Should oral contraceptives be made available over the counter rather than requiring a prescription?
Although they are 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 a doctor’s oversight is required.
If the FDA approves an overthe-counter version, it will be effectively saying that women with underlying health risks who choose that option will have to do their own research on how the birth control pill would interact with their condition and any medications they are taking.
Reproductive rights activists in the United States view an over-the-counter birth control pill as an easy and effective tool for rural, poor and historically marginalized communities to avoid unwanted pregnancies — reducing their barriers to health care and lowering the abortion rate along the way.
At least two drug companies want to apply to the FDA to make the switch to an over-thecounter version and have been in communication with the agency about their plans. But after years of preliminary trials to clear the agency’s research and consumer testing hurdles, neither has reached the stage of applying yet.
The FDA defenders say that by asking many questions and demanding rigorous testing, the agency is being prudent 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 prolonged preapplication process — which at certain points requires FDA permission to advance to the next stage. Some of them see the process as an obstacle to the advancement of reproductive rights, as well as a case study of the cost when the FDA takes an overly cautious approach. The agency has also been criticized in other drug-approval cases of moving too quickly, as when it fast-tracked approval of a controversial Alzheimer’s drug earlier this year.
Proponents of allowing overthe-counter access say they view the issue with greater urgency now that the Supreme Court is reconsidering the constitutional right to abortion as established by Roe v. Wade in 1973.
In the United States, close to $3 billion in prescription birth control pills are sold each year, according to the life sciences research firm Iqvia. They are manufactured by a variety of drug companies, including Pfizer and Bayer AG.
The push to approve an overthe-counter option is coming primarily from two smaller players: Cadence Health, which is planning to apply on behalf of its oral contraceptive, Zena; and HRA Pharma, a small drugmaker based in Paris.
Research shows birth control pills are safer than pregnancy itself, which carries a higher risk of blood clots, among other health concerns.
The FDA declined to address specific questions about Cadence and HRA Pharma but said it aims to make a decision within 10 months once any company submits an application for approval of a move from prescription to over-the-counter status. “The amount of time that a company spends in its development program prior to submitting an application for a prescription-to-nonprescription switch is determined by the company, not by the FDA,” an agency spokesperson said in a statement.
The two companies see it differently. They say they have sought the FDA’s blessing — and have at points been obligated to have it in order to proceed — throughout their preparations. “We are required to get their clearance to move to the next step in development. And we don’t have their clearance,” said Cadence co-CEO Samantha Miller. The FDA’s over-thecounter switch option appeals to some pharmaceutical companies because the first drug in its class to be switched can be granted three years of exclusivity in its market, giving it a temporary monopoly on over-the-counter sales. That advantage is one reason that the larger Dublin, Ireland-based pharmaceutical company Perrigo announced plans earlier this year to acquire HRA Pharma.
Cadence executives say approval for Zena is probably two years away at least — if they are successful at all with the FDA.
“We’ve had so many issues discussed and agreed with this FDA over the past five years,” said Miller. “At this point, there are now really some challenging issues that could prevent a successful [over-the-counter] switch.”