Advisers to the Food and Drug Administration unanimously recommended on Wednesday that the birth control pill Opill — generically known as norgestrel — should be available over the counter. While the agency won’t make its final decision until this summer, the 17-0 vote by two advisory panels is a big step toward allowing oral contraceptives to be dispensed without a prescription for the first time in the U.S.
What exactly is Opill?
Opill is a type of hormonal birth control pill that prevents pregnancy primarily by thickening cervical mucus to keep sperm from reaching an egg. It’s what’s known as a “minipill,” meaning it contains only a synthetic form of the hormone progesterone — unlike more commonly prescribed combination birth control pills, which contain both progesterone and estrogen. The FDA approved Opill as a prescription drug in 1973, but in other countries, such as the United Kingdom, it’s available without a prescription.
If the FDA approves Opill for over the counter availability, how would it work?
Given the advisory panels’ unanimous approval, Dr. Paul Blumenthal, a professor of ob-gyn at Stanford University, tells Yahoo Life that he believes “it’s highly likely that the FDA will approve the application.”
If approved as submitted, then Opill would be available just like any other OTC drug.
“It would be similar to if someone went to their local pharmacy and bought medication like ibuprofen or Tylenol without a prescription,” Dr. Gopika Krishna, a family planning expert and fellow in ob-gyn at Columbia University, tells Yahoo Life.
Opill drugmaker Perrigo hasn’t publicly disclosed how much over-the-counter Opill would cost. OTC drugs tend to be cheaper than prescription medicines, though they’re not covered by insurance.
What are some of the FDA’s concerns?
In an initial review posted on Friday, the FDA had some reservations about making the drug widely available without a prescription.
Blumenthal says there are generally four criteria to determine whether a medication is ready for OTC use:
Can users recognize their own need for the medication?
Does the medication have potential for abuse?
Are instructions easy to follow?
Can users recognize their own “contraindications” or reasons they shouldn’t take the drug?
The “need” is easy to recognize, and Opill — unlike some OTC medicines such as painkillers, which can be dangerous in large doses — doesn’t have potential for abuse. But the last two points gave the FDA pause.
FDA officials were worried about users being able to follow label instructions such as taking Opill within the same three-hour window every day, as minipills are less forgiving of missed or late pills than combination birth control pills.
Officials also worried that users may not recognize on their own that certain conditions would make Opill inappropriate for them. Women with a history of breast cancer or undiagnosed abnormal vaginal bleeding, for example, shouldn’t take the drug.
The FDA also expressed concern that Opill may be less effective in women who are overweight, citing studies about emergency contraception. On its website, Planned Parenthood says that emergency contraception like Plan B isn't as effective if you weigh more than 165 pounds. But the American College of Obstetricians and Gynecologists' practice guidelines state 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.”
Blumenthal says that “much of the discussion” at the FDA likely revolved around whether a health care professional was necessary to distribute the pills. In his view, he says, the advisory panel “correctly determined such a person was not necessary for a patient to make an informed decision to use this medication.”
Many major medical organizations agree, with the American Medical Association saying in a statement on Wednesday that “the benefits of widespread, nonprescription availability far outweigh the limited risk associated with their use — with evidence showing that pregnancy poses much greater health risks.”
What do parents need to know?
Blumenthal says it’s important for parents of teens to understand that Opill is safe and effective — “and we have over 50 years of experience to prove it.”
“Preventing an unintended pregnancy if you are a sexually active teen is a very important investment in being able to achieve your life goals, and parents need to recognize this even if they prefer that their teen not be sexually active,” he says.
It remains to be seen whether the FDA would impose age requirements on Opill, though the advisory panel did approve the application without any age restrictions. Emergency contraceptives like Plan B, for example, initially had restrictions for children under 16, but those age limits were eventually removed.
“Multiple medication organizations, including the American College of Obstetricians and Gynecologists, have supported access to OTC contraception without age restriction,” Krishna says. “Adolescents can face significant barriers to accessing contraception, so it is important to support increasing access to contraceptive methods.”
What could this mean for birth control pills going forward?
The move to make birth control pills easily accessible is gaining steam, with New York passing legislation earlier this month allowing pharmacists to dispense OTC contraceptives. Opill’s approval could open the door for more OTC birth control options in the future.
“I think we may have cracked the glass ceiling for OTC contraception with hormonal contraceptives in the U.S.,” Blumenthal says. “In many other countries, OTC status of not only progestin-only pills but also combined oral contraceptives has been a fact for years, if not decades, so it’s high time we caught up with this global trend.”
Wellness, parenting, body image and more: Get to know the who behind the hoo with Yahoo Life's newsletter. Sign up here.