8-jan-17

A French pharmaceutical company will apply for FDA approval to make a progestin contraceptive pill available over the counter in the US. It’s about time.

Over-the-counter birth control is very likely to become a reality in the United States, Vox has learned. It will be several years, at least, before the Food and Drug Administration actually approves an oral contraceptive pill for use without a prescription — but the first steps of the process are underway.

The best way to prevent unwanted pregnancy is to make it as easy as possible for women to access birth control. But in most states, women can only get hormonal contraception with a prescription from a doctor — which requires time and money for doctors’ visits that some women just don’t have. And since oral contraceptive pills are incredibly well-studied and incredibly safe, many advocates and experts think it’s time to make them available over the counter without a prescription.

The American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians agree that oral contraceptives are appropriate for over-the-counter use. The idea even has bipartisan support in Congress, although there are sharp disagreements over issues like whether and how insurance should pay for it.

The problem with making over-the-counter birth control a reality hasn’t been 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.

But now that company has been found. HRA Pharma in Paris is partnering with advocates and experts from Ibis Reproductive Health, an international nonprofit research organization for reproductive health, to start the process of bringing an over-the-counter oral contraceptive to the US market.

“At HRA, we are proud of our pioneering work to expand access to contraception for millions of women,” the company told Vox in a statement. “Oral contraceptives are some of the best-studied medicines on the market today and enjoy longstanding support from medical and public health experts.”

Ibis president Kelly Blanchard told Vox that she doesn’t want to speculate on how long it will take to bring the pill to market, and that the exact name or chemical composition of the pill isn’t public yet. But their aim is to submit an application to the FDA “within a few years,” she said, and some pieces of the application and research are already underway.

The first OTC pill will be progestin-only, not combined estrogen and progestin

There are two major types of oral contraceptives, progestin-only and combined pills that contain both progestin and estrogen. Ibis and HRA plan to seek FDA approval for a progestin-only pill.

Progestin-only pills present the fewest barriers for the broadest population, Blanchard said. Both types of pills are equally effective, but combined pills with estrogen cause potential problems for women who smoke or have high blood pressure, for instance, that progestin-only pills don’t.

The other benefit is that emergency contraception, which is already FDA-approved, is also a progestin pill. That means it will probably be easier to get the progestin-only oral contraceptives approved.

But Blanchard said that after the first OTC pill is approved, it shouldn’t be difficult to get other forms of birth control approved, too. That’s important so that women can have more than one over-the-counter option, since not every pill or every birth control method is right for every woman.

What about the politics of it all?

While it’s true that OTC birth control is a bipartisan idea, there’s a bit of a catch.

A major legacy of the Affordable Care Act (ACA) was making health insurance cover contraception at no additional cost to women. Not making women pay extra on top of their insurance premiums makes birth control much more accessible.

But Republicans, of course, say they want to repeal the ACA, and the birth control benefit along with it. Republicans proposed legislation in 2015 to speed up the FDA’s over-the-counter approval process for contraception — but Democrats and women’s health advocates criticized that bill as a cynical ploy to undermine the ACA while only appearing to support birth control and women’s health.

That bill would have imposed an 18-and-over age restriction, which Blanchard said was completely unnecessary; women’s health advocates have already had a similar fight with the FDA over age restrictions for emergency contraception (which is even more politicized than regular birth control because of the false belief that it can cause abortion).

“Unfortunately, it seems that no matter what you do around birth control in the US, there is going to be some kind of political backlash,” said Krishna Upadhya, an assistant professor at the Johns Hopkins University School of Medicine and a member of the Oral Contraceptives Over-the-Counter Working Group, which Ibis convened in 2004 to study and advocate for OTC birth control. “But I actually think this is one of the great reasons to support having over-the-counter access,” she added.

When women don’t have to go through doctors or pharmacies to get birth control, they are less subject to the whims of regulation changes, religiously objecting pharmacists, or other potential hassles and headaches. And the FDA’s decision-making process is based on evidence, not partisanship.

As for whether Trump’s appointees could cause political problems for approving over-the-counter contraception, Blanchard said she hopes that the FDA “will follow their process and judge it on its merits. And we think the merits are strong.”

http://www.vox.com/2016/12/30/14120874/birth-control-over-the-counter-fda-ibis-hra-pharma

Source: Vox