Advisors to the Food and Drug Administration unanimously recommended on Wednesday that the birth control pill Opill — commonly known as norgestrel — should be available without a prescription. 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 enabling over-the-counter oral contraceptives for the first time in the US.
What exactly is Opill?
Opill is a type of hormonal contraceptive pill that prevents pregnancy mainly by thickening cervical mucus to prevent sperm from reaching an egg. It’s what’s known as a “minipill,” meaning it only contains a synthetic form of the hormone progesterone — unlike the 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 is available without a prescription.
If the FDA approves Opill for over-the-counter availability, how would it work?
Given the unanimous approval of the advisory panels, Dr. Paul Blumenthal, a professor of ob-gyn at Stanford University, told Yahoo Life that he believes “it is very likely that the FDA will approve the application.”
If approved as filed, Opill would be available just like any other OTC drug.
“It would be similar to someone going to the local pharmacy and buying a drug like ibuprofen or Tylenol without a prescription,” says Dr. Gopika Krishna, a family planning expert and fellow in ob-gyn at Columbia University, told Yahoo Life.
Opill drugmaker Perrigo has not disclosed how much over-the-counter Opill would cost. OTC drugs are usually less expensive than prescription drugs, although they are not covered by insurance.
What are some of the FDA’s concerns?
In an initial review published Friday, the FDA had some reservations about making the drug widely available without a prescription.
Blumenthal says there are generally four criteria for determining if a drug is ready for OTC use:
-
Do users recognize their own need for the medication?
-
Does the medication have potential for abuse?
-
Are instructions easy to follow?
-
Do users recognize their own “contraindications” or reasons not to use the drug?
The “need” is easy to spot, and Opill — unlike some OTC drugs like pain relievers, which can be dangerous in large doses — has no potential for abuse. But the last two points gave the FDA pause.
FDA officials were concerned that users might follow label instructions, such as taking Opill within the same three-hour window every day, since minipills are less forgiving of missed or overdue pills than combined birth control pills.
Officials also worried that users might not recognize for themselves that certain circumstances would make Opill unsuitable for them. For example, women with a history of breast cancer or undiagnosed abnormal vaginal bleeding should not take the drug.
The FDA also raised concerns that Opill may be less effective in overweight women, citing studies on emergency contraception. On its website, Planned Parenthood says 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 “obese women can be offered all options for hormonal contraception with the reassurance that hormonal contraceptive efficacy is not significantly affected by weight.”
Blumenthal says “much of the discussion” at the FDA probably revolved around whether a health care professional was needed to distribute the pills. In his opinion, he says, the advisory panel “correctly determined that such a person was not necessary for a patient to make an informed decision to use this drug.”
Many major medical organizations agree, with the American Medical Association saying in a statement Wednesday that “the benefits of widespread, nonprescription availability far outweigh the limited risk associated with its use — with evidence showing that pregnancy carries much greater health risks.”
What should parents 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 when you are a sexually active teen is a very important investment in achieving your life goals, and parents need to recognize this, even if they prefer their teen not to be sexually active,” he says.
It remains to be seen whether the FDA will impose age requirements on Opill, although the advisory panel approved the application without any age restrictions. Emergency contraceptives like Plan B initially had restrictions for children under 16, but those age limits were eventually lifted.
“Multiple medication organizations, including the American College of Obstetricians and Gynecologists, have supported access to OTC birth control without age restrictions,” says Krishna. “Adolescents can face significant barriers to accessing contraception, so it’s important to support increasing access to contraceptive methods.”
What could this mean for birth control pills in the future?
The move to make birth control pills easily accessible is gaining momentum, with New York earlier this month passing legislation allowing pharmacists to dispense over-the-counter contraceptives. Opill’s approval could open the door for more OTC birth control options in the future.
“I think we’ve cracked the glass ceiling for OTC birth control with hormonal contraceptives in the US,” says Blumenthal. “In many other countries, the OTC status of not only progestin-only pills, but also combined oral contraceptives has been established for years, if not decades, so it is high time we caught up with this global trend.”
Wellness, parenting, body image and more: meet the WHO behind the how with the Yahoo Life newsletter. Register here.
