As FDA advisers consider OTC birth-control pill, agency scientists worry it won't work. Here's why

8 NEWS AT SIX. TONIGHT, LAWMAKERS MAY HAVE FOUND SOME RARE COMMON GROUND AT THE STATE HOUSE OVER WOMEN’S HEALTH CARE. DEMOCRATS ARE MOVING FORWARD WITH SEVERAL PROPOSALS TO MAKE SWEEPING CHANGES TO REPRODUCE OF RIGHT. KCCI CHIEF POLITICAL REPORTER AMANDA ROOKER SHOWS US WHY ONE COULD EVENTUALLY BECOME LAW. STACEY JAMES, IOWA REPUBLICANS AND DEMOCRATS DISAGREE ON MOST THINGS WHEN IT COMES TO REPRODUCTIVE HEALTH CARE, BUT BOTH PARTIES ARE MOVING FORWARD WITH PLANS THAT WOULD INCREASE ACCESS TO BIRTH CONTROL. HOUSE DEMOCRATS UNVEILED A NEW BILL MONDAY TO MAKE BIRTH CONTROL MORE ACCESSIBLE FOR IOWANS OVER THE AGE OF 18. IT WOULD MAKE SOME CONTRACEPTIVES AVAILABLE THROUGH PHARMACISTS WITHOUT NEEDING A DOCTOR’S PRESCRIPTION. PHARMACISTS, ESPECIALLY IN RURAL IOWA, ARE AN IMPORTANT RESOURCE AND AN IMPORTANT PART OF THIS EQUATION. THEY ARE AN ACCESS POINT FOR CARE AND COULD HELP MITIGATE BARRIERS AND EXPAND ACCESS TO CONTRACEPTION. LAST WEEK, SENATE LAWMAKERS PASSED A SIMILAR BILL. NEITHER PLAN INCLUDES ABORTION RELATED PILLS, BUT WOULD APPLY TO CONTRACEPTIVES LIKE THE PILL PATCH AND RING THE THREE FORMS OF BIRTH CONTROL THAT HAVE BEEN USED OVER SEVERAL DECADES IN A SAFE WAY TO ENSURE THAT WOMEN HAVE BIRTH CONTROL, THAT THEY NEED NOT JUST FOR MATERNAL HEALTH, BUT ALSO FOR WOMEN’S HEALTH IN GENERAL. REPUBLICAN SENATOR CHRIS COURNOYER SAYS WOMEN IN THE SENATE FROM BOTH PARTIES HAVE BEEN A STRONG COLLECTIVE VOICE OF SUPPORT. WE KNOW HOW IMPORTANT IT IS, AND I THINK THE FACT THAT WE STOOD UP AND VOICED OUR SUPPORT FOR IT AND IN OUR CAUCUSES AND THE FACT THAT IT WAS OVERWHELMING BIPARTISAN SUPPORT SHOWS THAT THE VOICES OF THE WOMEN IN OUR LEGISLATURE ARE BEING HEARD. REPUBLICAN REPRESENTATIVE DEVIN WOOD IS RUNNING A BILL THAT INCLUDES A SIMILAR BIRTH CONTROL PLAN IN THE IOWA HOUSE. I THINK IT IS JUST, YOU KNOW, INCREDIBLY IMPORTANT TO OUR HEALTH CARE SYSTEM TO SUPPORT YOU KNOW, OUR MATERNAL HEALTH CARE. BUT SHE SAYS HER PARTY IS STILL DISCUSSING POSSIBLE CHANGES, FINDING THE BEST PATH FORWARD. OVER-THE-COUNTER BIRTH CONTROL IS ALSO A TOP PRIORITY FOR GOVERNOR KIM REYNOLDS. SHE INTRODUCED A SIMILAR PLAN BACK IN 2019 THAT YOUR SENATE LA

When Caitlyn Pace moved from the United States to Hong Kong three years ago to take a teaching job, she loved the food, the sights and the birth control.She was pleasantly surprised to find that in Hong Kong, she could get oral contraceptives at her neighborhood drugstore without a prescription."My jaw probably dropped the first time I did it. I just walked in and kind of looked around and was like 'is this really happening?'" said Pace, 34. "It's like buying aspirin."For years, medical organizations have fought to have over-the-counter birth control pills in the U.S., too.On Tuesday and Wednesday, a group of external advisers to the U.S. Food and Drug Administration will discuss an application from a pharmaceutical company to put their prescription birth control pill over the counter.Although professional organizations including the American Medical Association and the American College of Obstetricians and Gynecologists support over-the-counter sales of the drug, called Opill, the FDA seems skeptical, citing a list of concerns in a 130-page document posted online Friday."I am worried" about the FDA's decision, said Dr. Kristyn Brandi, a spokesperson for the American College of Obstetricians and Gynecologists.Concerns about weight, following the labelThe FDA scientists say they have two main concerns about Opill, a "mini pill" that uses only the hormone progestin.One has to do with obesity. The FDA approved Opill as a prescription drug in 1973, and "the prevalence of obesity in adults in the United States has changed dramatically since the original clinical studies were conducted over 50 years ago," the scientists wrote in the document, citing a 13% obesity rate in 1960 compared with a 42% obesity rate now."The degree to which efficacy of is diminished in individuals who are overweight or obese (which together now represent approximately 60% of the U.S. reproductive-aged population ... ) remains unknown," they added.The agency cited a 2016 report analyzing data from four studies that suggested women who were obese had an increased risk of pregnancy after taking emergency contraception. The data in those four studies was "limited and poor to fair quality," the authors wrote.Brandi said she was surprised by the FDA's statements.In a practice document for its members, the American College of Obstetricians and Gynecologists cites several studies showing that "women with obesity can be offered all hormonal contraceptive method options with reassurance that the efficacy of hormonal contraception is not significantly affected by weight."Brandi, an obstetrician-gynecologist in New Jersey, noted that even though obesity has been on the rise, there has not been a higher rate of failure for birth control pills.The FDA scientists were also concerned that studies by Perrigo, the company that manufactures Opill, showed some women didn't follow the label instructions. They said some women in the study didn't take the pill within the same three-hour window every day, which is important for efficacy.But Brandi said even when doctors prescribe pills, patients don't always take them properly all the time."They make mistakes, and we know that," she said. "People are humans, and that's OK."The Opill label tells women that if they're more than three hours late taking their pill, they should take a pill as soon as they remember and use an additional form of birth control, such as a condom, for two days."I trust patients that they'll be able to read the instructions and follow the instructions and be able to use the medication safely and effectively," Brandi said. "I don't worry, because I trust women. I trust my patients."In a statement, Perrigo said that "data from our eight-year development program show that consumers can use Opill safely and effectively as guided by the proposed labeling."The FDA also expressed concern that without counseling from a doctor, women might not realize when Opill wasn't appropriate for them.For example, the Opill label states that the drug should not be used by women with a history of breast cancer. But when 205 study subjects with a history of breast cancer read the label, six of them said the pill was right for them.Women with undiagnosed abnormal vaginal bleeding also are not supposed to use Opill, but in a study, more than half of those with this condition said the pill was appropriate for them.A letter from lawmakers The FDA is under pressure to allow Opill to go over-the-counter from elected officials as well as healthcare providers.Unwanted pregnancies are a public health issue in the U.S., where almost half of all pregnancies are unintended, according to the FDA briefing document, and rates are especially high among lower-income women, Black women and those who haven't completed high school.In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception."This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system," the lawmakers wrote.Califf responded that the FDA "acknowledges the public health benefits of increased access to oral contraceptives" and that "the Agency's decision making is guided by the best available science."The FDA advisers are expected to vote Wednesday on whether to recommend that the agency approve Opill going over-the-counter. The agency often follows the recommendations of its advisers but doesn't always do so.

When Caitlyn Pace moved from the United States to Hong Kong three years ago to take a teaching job, she loved the food, the sights and the birth control.

She was pleasantly surprised to find that in Hong Kong, she could get oral contraceptives at her neighborhood drugstore without a prescription.

"My jaw probably dropped the first time I did it. I just walked in and kind of looked around and was like 'is this really happening?'" said Pace, 34. "It's like buying aspirin."

For years, medical organizations have fought to have over-the-counter birth control pills in the U.S., too.

On Tuesday and Wednesday, a group of external advisers to the U.S. Food and Drug Administration will discuss an application from a pharmaceutical company to put their prescription birth control pill over the counter.

Although professional organizations including the and the support over-the-counter sales of the drug, called Opill, the FDA seems skeptical, citing a list of concerns in a posted online Friday.

"I am worried" about the FDA's decision, said Dr. Kristyn Brandi, a spokesperson for the American College of Obstetricians and Gynecologists.

Concerns about weight, following the label

The FDA scientists say they have two main concerns about Opill, a "mini pill" that uses only the hormone progestin.

One has to do with obesity. The FDA approved Opill as a prescription drug in 1973, and "the prevalence of obesity in adults in the United States has changed dramatically since the original clinical studies were conducted over 50 years ago," the scientists wrote in the document, citing a 13% obesity rate in 1960 compared with a 42% obesity rate now.

"The degree to which efficacy of [Opill] is diminished in individuals who are overweight or obese (which together now represent approximately 60% of the U.S. reproductive-aged population ... ) remains unknown," they added.

The agency cited a analyzing data from four studies that suggested women who were obese had an increased risk of pregnancy after taking emergency contraception. The data in those four studies was "limited and poor to fair quality," the authors wrote.

Brandi said she was surprised by the FDA's statements.

In a for its members, the American College of Obstetricians and Gynecologists cites several studies showing that "women with obesity can be offered all hormonal contraceptive method options with reassurance that the efficacy of hormonal contraception is not significantly affected by weight."

Brandi, an obstetrician-gynecologist in New Jersey, noted that even though obesity has been on the rise, there has not been a higher rate of failure for birth control pills.

The FDA scientists were also concerned that studies by Perrigo, the company that manufactures Opill, showed some women didn't follow the label instructions. They said some women in the study didn't take the pill within the same three-hour window every day, which is important for efficacy.

But Brandi said even when doctors prescribe pills, patients don't always take them properly all the time.

"They make mistakes, and we know that," she said. "People are humans, and that's OK."

The Opill label tells women that if they're more than three hours late taking their pill, they should take a pill as soon as they remember and use an additional form of birth control, such as a condom, for two days.

"I trust patients that they'll be able to read the instructions and follow the instructions and be able to use the medication safely and effectively," Brandi said. "I don't worry, because I trust women. I trust my patients."

In a statement, Perrigo said that "data from our eight-year development program show that consumers can use Opill safely and effectively as guided by the proposed labeling."

The FDA also expressed concern that without counseling from a doctor, women might not realize when Opill wasn't appropriate for them.

For example, the Opill label states that the drug should not be used by women with a history of breast cancer. But when 205 study subjects with a history of breast cancer read the label, six of them said the pill was right for them.

Women with undiagnosed abnormal vaginal bleeding also are not supposed to use Opill, but in a study, more than half of those with this condition said the pill was appropriate for them.

A letter from lawmakers

The FDA is under pressure to allow Opill to go over-the-counter from elected officials as well as healthcare providers.

Unwanted pregnancies are a public health issue in the U.S., where almost half of all pregnancies are unintended, according to the FDA briefing document, and rates are especially high among lower-income women, Black women and those who haven't completed high school.

In March 2022, 59 members of Congress wrote to FDA Commissioner Dr. Robert Califf about OTC contraception.

"This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system," the lawmakers wrote.

Califf responded that the FDA "acknowledges the public health benefits of increased access to oral contraceptives" and that "the Agency's decision making is guided by the best available science."

The FDA advisers are expected to vote Wednesday on whether to recommend that the agency approve Opill going over-the-counter. The agency often follows the recommendations of its advisers but doesn't always do so.

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