'Free the Pill' Will Appeal to FDA for Over-the-Counter Contraception
Fights over insurance have stymied the push for OTC pills, but a new coalition could sidestep this by appealing directly to the FDA.
Is the time ripe for a real push to free birth-control pills from prescription-only status?
Efforts over the past few years have failed, thanks in part to partisan dogma around the Affordable Care Act (ACA) and its controversial contraception mandate. But the political climate is obviously a lot different in 2017 than it was before Donald Trump took office. Less socially conservative than prior GOP administrations with regulators committed to TKTKTK, and this could be the time to strike while the proverbial iron is hot.
It's up to the Food and Drug Administration (FDA) to rule on whether a drug is suitable for over-the-counter (OTC) sales. It takes two here, however—to start the process, a contraception manufacturer must apply with the FDA.
That's where the "Free the Pill" coalition kicks in. A joint project of French drug-company HRA Pharma and the nonprofit Ibis Reproductive Health, the goal is to get the FDA's permission to sell hormonal oral-contraception—aka "the pill"—to people who don't have a doctor's prescription. Right now, the companies are focusing on progesterone-only pills and still in the TKTKTK stages.
This wouldn't be the first time HRA Pharma has broken through regulatory barriers. The company's first product was an emergency contraceptive pill, which in 2000 became the first of its kind available over-the-counter to people of all ages. (The FDA wouldn't approve emergency-contraception for OTC sale here until 2013.) Meanwhile, Ibis conducts original (clinical and survey) research with a focus on "expanding contraceptive access and choices" and has published dozens of peer-reviewed papers on the OTC contraception, going back to 1993.
Free the Pill is a long-time Ibis initiative to move American oral-contraceptives over the counter. Since 2004, it has run an OTC oral-contraceptives working group to study and promote awareness about the issue. Supporters now include influential medical associations like The American College of Obstetricians and Gynecologists and nonprofits ranging from the American Civil Liberties Union to Catholics for Choice, Feminist Majority Foundation, The National Campaign to Prevent Teen and Unplanned Pregnancy, Planned Parenthood Federation of America, and the National Organization for Women.
Until now, the initiative was hindered by its lack of entities with standing to challenge contraception's classification, but HRA Pharma has filled that void. Ibis is currently (conduct research in support of an application to the FDA which HRA will submit????TKTKTK). The process could still take TKTKTTK.
But this is potentially a big step.
"Women in over 100 countries can access birth control pills without a prescription," said Young Women United Policy Director Denicia Cadena, "and American women are closer to this goal than ever before, with an OTC progestin-only birth control pill literally on the horizon."
The two key questions here are how the Trump administration will react and whether Congress could (and would be willing to) do anything to help the process along.
As Emily Crockett noted at Vox, "The problem with making over-the-counter birth control a reality hasn't been [lack of] evidence, or even necessarily politics. The problem has been finding a pharmaceutical company that is actually willing to go through the long slog of getting one of its own drugs approved by the FDA for over-the-counter use."
I first covered over-the-counter pills for Reason in 2014, when an FDA spokesperson told me the agency "is willing to meet with any sponsor, including those of oral contraceptives, who may want to propose switching their product to OTC status."
Apparently none have stepped forward. As surgeon and Cato Institute scholar Jeffrey Singer told me then, liberating birth control from the prescription model "would drive down the prices substantially."
Drugmakers can command higher prices from insurance companies than they could from consumers in a free market—which should be a mark in favor of OTC pills for those worried about affordability. Yet Obamacare's contraception mandate clouded the issue for a few years. If health insurers were now required to provide "free birth control" to everyone and everyone was required to have health insurance, the cost problem had been solved, liberals argued.
Of course, in reality, there are still many (low-income) people without insurance coverage, many reasons why women with insurance might not be able to use it for contraception, and a host of other reasons why attaching affordability to insurance mandates is a bad idea. (Not to mention the fact that "free" drug costs are passed on to patients in other ways.) It leads to endless litigious run-ins between birth-control access and religious liberty (which is part of what fueled Republican support for OTC birth control in the final years of the Obama administration). It tethers access to doctor's visits and insurer rules restricting purchase to a one-month supply. And it makes prices contingent on both the continued existence of the constantly-under-attack ACA and the whims of Trump's Department of Health and Human Services (HHS).
Even if the bumbling ACA-repeal efforts of Congressional Republicans continue to fail, HHS could change the list of services and drugs insurers must cover with no point-of-service cost to consumers.
Now that the contraception mandate might be in trouble, women's groups and media are getting re-interested in legalizing OTC contraception. [Ibis Reproductive Health hopes to aid these efforts???? with outreach to insurance companies about covering OTC pills (cheaper than unplanned pregnancy) and dispelling the idea that OTC pills will automatically be dropped from insurance coverage. TKTKTK]
Free the Pill "has made insurance coverage one of its top advocacy priorities," it said in a recent statement. "When [over-the-counter] contraception hits the market, cost should not be a barrier, nor should OTC birth control only be a luxury for those who can afford it."
Will Republicans politicians still lend support now that it doesn't stick it to Democrats? [????????]
"Over-the-counter contraception hasn't emerged as something with clear bipartisan cooperation and the reason largely comes down to an issue of insurance," Mother Jones noted earlier this year. "The Left and Right, to put it simply, can't agree on who should cover the cost of over-the-counter pills."
And would the FDA even go for it in the first place? The Trump FDA has been friendly to the idea of deregulation.
"I believe the pill meets the FDA criteria for over-the-counter sale," said Daniel Grossman, a professor of obstetrics and gynecology with the University of California, San Francisco, and director of the group Advancing New Standards in Reproductive Health. "There is no risk of overdose with the pill, nor is it addictive. Women determine on their own if they are at risk of unintended pregnancy and need to use contraception. We also have data that women can figure out if they have a medical condition that may put them at higher risk if they take the pill, or may make the pill less effective. No complicated tests or doctor's visits are needed."
