From The Editors Health

FDA Approves Swedish Birth Control App ‘Natural Cycles’ for Marketing in the U.S.

The United States Food and Drug Administration (FDA) on Friday (August 10) gave its nod of approval for the marketing of a Swedish App called Natural Cycles as a tech-based method of contraception in the country.

While the app has been in use in the European Union ever since it was certified by the concerned European organization for inspection and certification in February last year, it is the first time an app-based form of contraception has been approved for use in the U.S.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” said Terri Cornelison – assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.

“But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” she warned.

Welcoming the FDA clearance, the Stockholm-based company tweeted:
“We are delighted that the US Food and Drug Administration (FDA) has cleared Natural Cycles as the first digital method of birth control in the US #contraception #FDA.”

The Natural Cycles app will be available to subscribers at an annual fee of about $80 and will include a basal thermometer for the user to take a temperature reading immediately upon waking up each morning and logging it in the app.

A basal thermometer is more sensitive and accurate as opposed to a regular fever thermometer, in that it displays the readings with two decimal places.

Based on menstrual cycle information and early morning temperature inputs by women, the app uses an algorithm to determine the fertility of the user on a given day and then flags it as a fertile or infertile day, depending on the calculations.

A red day indicates that the user is fertile, which means having unprotected sex on a red-flagged day would likely result in pregnancy.

It then depends on the user to abstain from sex on red days or use a contraceptive – or just go for it if the user is actually looking to get pregnant – no better day than a red day for that.

Conversely, a green day would mean the user is infertile and indulging in sexual intercourse on such a day definitely reduces the risk of conception but does not eliminate it altogether, as already mentioned.

More than 15,000 women were made to use the app for a period of eight months as part of a clinical study to determine the effectiveness of Natural Cycles as a method of birth control.

The findings revealed that “the app had a “perfect use” failure rate of 1.8 percent, which means 1.8 in 100 women who use the app for one year will become pregnant because they had sexual intercourse on a day when the app predicted they would not be fertile or because their contraceptive method failed when they had intercourse on a fertile day,” the FDA explains.

“The app had a “typical use” failure rate of 6.5 percent, which accounted for women sometimes not using the app correctly by, for example, having unprotected intercourse on fertile days,” says the agency.

This method of contraception through fertility awareness, however, is not without its fair share of controversy.

Out of 668 women who underwent abortions at a Stockholm hospital between September and December 2017, 38 of them had been using the Natural Cycles app, necessitating an investigation by the country’s Medical Products Agency, which is currently ongoing and expected to last until September.

In July, an investigation into the Natural Cycles marketing was initiated by the Advertising Standards Authority (ASA) in the U.K., after it received three complaints about the app and its paid ad on Facebook that vouches for the high accuracy of the app for use as contraception, based on clinical trials.

“We would require robust substantiation from any company to support such a claim,” said an ASA spokesman.

To be fair to Natural Cycles, its Facebook page is chock-a-block with user testimonials in support of the app, as well, with one woman going to the extent of posting “the launch of a petition against any possibility of the app being banned in Sweden following the Medical Product Agency’s investigation,” reports the Guardian.

A U.K. charity known as The Family Planning Association told the Guardian that Natural Cycles’ claims to contraception is a cause for concern.

FDA spokesperson Deborah Kotz declined to comment on the ASA investigation, other than saying that the FDA expected Natural Cycles to follow the agency’s own set of marketing policies, according to VICE.

She did, however, acknowledge that the agency was aware of the investigation and had even contacted the Swedish authorities in that regard.

“An increase in the absolute numbers of unintended pregnancies is expected with a growing number of users,” VICE News quoted Kotz as saying.

“We reached out to the Swedish authorities and feel that the information regarding the pregnancies in Sweden is consistent with our knowledge concerning the pregnancy risks associated with the use of this device,” she said.

“We are in contact with the ASA and, since the investigation is ongoing, it would not be appropriate for us to speculate on the outcome,” The Guardian quoted a Natural Cycles spokeswoman to have said.

“We can confirm however, that the ASA complaint in relation to the Facebook advertisement in question was actually raised in 2017.

“The advertisement which only ran for a few weeks has been taken out of circulation and we have accepted the draft recommendations very recently shared with us by the ASA,” she said.

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