People over 35 years old who are smokers or those who have poorly controlled high blood pressure or blood-clotting disorders may be advised to avoid combination pills.Д«oth companies must also ensure consumers can understand the label and follow directions accompanying the medication.ДЄ spokesperson for HRA Pharma declined to comment on the FDA process but said the company strives to meet womenвЂ™s unmet medical needs. Cadence makes a combination pill that contains a mix of estrogen and a progestin.

Hana is a progestin-only pill, which means there is less likelihood of adverse reactions. Some advocates say itвЂ™ll likely be easier to make HRAвЂ™s over-the-counter because it poses fewer risks to different groups of people.

вЂњI donвЂ™t think that we would have embarked on this if that werenвЂ™t the case, and that should influence FDA to support it,вЂќ said Samantha Miller, co-CEO of Cadence Health.Д«irth control pills, while overwhelmingly safe, can complicate some underlying health conditions and have always required a doctorвЂ™s supervision. The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians have backed over-the-counter birth control pill options, which OTC advocates say makes it clear that FDA can and should endorse the switch. The Oral Contraceptives Over-the-Counter Working Group, which counts Wood as a member, began working with HRA Pharma in 2016 to conduct research to help support an application for an OTC designation. Marsha Blackburn (R-Tenn.) questioned the legal precedent establishing the right to privacy for contraceptive access during Supreme Court Justice Ketanji Brown JacksonвЂ™s nomination hearings.ДЄ coalition of reproductive rights groups, researchers and clinicians has worked to bring hormonal contraceptives over the counter for nearly two decades. Meanwhile, some conservative lawmakers are working to restrict access to contraception, and Sen. вЂњThe health and well-being of people capable of pregnancy across America is at stake,вЂќ 59 House members led by the chairs of the Pro-Choice Caucus wrote FDA Commissioner Robert Califf in March. вЂњThe reviewers and the leadership get pressures from all directions, so itвЂ™s really important that any kind of protection around FDA is in place and it is maintained and strengthened because itвЂ™s not perfect,вЂќ said Wood, now a health policy professor at George Washington University.Дemocratic lawmakers are pressuring the FDA to move quickly once the applications are submitted.

The prospect of having a daily birth control pill available anywhere people can purchase medicines without a doctorвЂ™s supervision comes nearly two decades after a bruising battle at FDA over making the emergency contraception drug known as вЂњPlan BвЂќ available over the counter - a political row that prompted the resignation of Susan Wood, the agencyвЂ™s director of the Office of WomenвЂ™s Health. вЂњAccess to the pill over the counter really is an equity issue, and now more than ever we need to be doing everything in our power to break down barriers to contraception, knowing that access to abortion is going to become much harder in this nation,вЂќ said Raegan McDonald-Mosley, CEO of Power to Decide, a nonprofit that works to prevent unplanned pregnancies.

Over the counter birth control