The U.S. Food and Drug Administration (FDA) approved the first over-the-counter hormonal contraceptive on the market last week. Opill, a single synthetic hormone pill manufactured by Perrigo Co., is expected to be available for purchase at pharmacies, convenience stores, grocery stores, and online.
Although the FDA states that “Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex,” progestin, the single synthetic hormone in Opill, has two modes of action. It thickens cervical mucus to decrease the chances of sperm reaching the egg, but, in some cases, can also prevent implantation of a fertilized egg by thinning the uterine lining, subsequently acting as a chemical abortifacient.
The Catholic Medical Association, a group of 2,600 healthcare professionals, issued a same-day press release expressing “deep concern” about the FDA’s decision and deriding the organization’s negligence.
“This shows a total lack of regard for a woman’s health to offer a hormonal contraceptive available over the counter, without medical supervision,” said Kathleen Raviele, M.D., OBGYN on CMA’s Board of Directors. “Women should be seen by a physician to make sure a drug as potent as a birth control pill is safe for her to take. These women deserve authentic medical care.”
Ignoring Over-the-Counter Requirements
According to the executive director of the Association of American Physicians and Surgeons Jane Orient, standard safety procedures are not being applied when it comes to making Opill available without a prescription.
“Over-the-counter products are supposed to be safe enough to be used without medical supervision,” she said in an interview. “Oral contraceptives should not be used without supervision. There is a significant risk of serious side effects.”
The Opill side effects listed by the Catholic Medical Association are numerous and complicated. For example, the pill should not be taken by women who have underlying medical conditions including breast cancer, certain liver diseases, unexplained uterine bleeding, or in conjunction with certain medications. Like most hormonal contraceptives Opill can lead to increased risk for breast lumps, ovarian cysts, depression, and various other issues. The pill is also ineffective if not taken at the same exact time each day.
According to the FDA’s decisional memo, the FDA requires data-driven evidence that consumers can use a drug safely and effectively without physician oversight for a drug to drop prescription status. Ultimately, although consumer behavior data revealed “very good consumer comprehension,” the “percentage of participants with limited literacy was not as high as FDA requested.”
What’s more, Opill’s “Actual Use” data set presented a “significant problem” — no explanation was offered for why 30 percent of participants reported taking more tablets than they were originally given. This problem “limited [the data’s] usefulness in assessing likely consumer behavior in certain circumstances, particularly around taking the medication every day, and at the same time of day.”
Yet even with these issues, top doctors at the FDA have determined that the potential “benefits” of the drug — namely preventing and potentially eliminating unwanted pregnancy — outweigh the risks.
“FDA convened an advisory committee meeting of outside scientific experts to discuss the data from this application and the committee unanimously voted that the drug’s potential benefits when used in the nonprescription setting outweighed its potential risks,” said FDA Office of Media Affairs press officer Jeremy Kahn in an email on July 18.
A Failure for Women’s Health
Opill is not a new drug, available by prescription since first approved by the FDA in 1973. But it has never been a top choice for OB-GYNs due to the side effects, including irregular bleeding lasting up to six months in some cases, according to Raviele.
“This is a drug that has a lot of side effects,” she said in an interview.
Decades of extensive medical studies have confirmed the risks and negative health implications of hormonal contraceptives. They are classified as Class 1 carcinogens by the World Health Organization with various links to cancer, and an American Journal of Psychiatry study found them to triple the risk of suicide.
And while the FDA repeatedly markets the positive role of Opill in limiting unintended pregnancies, “User effectiveness rates in real life are far lower than what is reported in pharmaceutical trials especially among children and young adults,” as Michelle Cretella, M.D. — the American College of Pediatrics Adolescent Sexuality Council co-chair — shared in an interview.
Yet supporters continue to advance hormonal contraceptives, applauding an over-the-counter option.
According to Cretella, easy access to hormonal contraceptives is going to hit two vulnerable populations the hardest — the unborn and young females.
“Children who otherwise would have remained abstinent will choose to experiment sexually, and others will experiment with sex at younger ages,” Cretella said. “Sexual abuse can be expected to increase as sexual predators have a new tool to pressure their victims and hide their involvement in sex trafficking.”
Raviele also mentioned the pill’s negative effect on young girls. “The typical rate for pregnancy with [Opill] is 13 percent,” she said. “Many girls will become pregnant on this drug and then seek an abortion. This will increase sexual promiscuity and promote STDs. This is very misleading.”
Increased abortions, promiscuity, STDs, cancer, and support for sex trafficking — all approved and moving to market.
“The social impact of this decision is dramatic,” said Tim Millea, M.D. and Chair of CMA’s Health Care Policy Committee, in the press release. “More women, particularly adolescents and young adults, will develop these adverse effects. In addition, as they will no longer need medical evaluation to receive contraceptives, the delayed and missed diagnosis of cancer and sexually transmitted infections will become common.”
He continued, “Sex traffickers will be free to purchase OTC contraceptives for the women under their control. This is not a victory for women’s health.”
Furthermore, like most synthetic hormonal contraceptives, Opill can also impact a woman’s mental state, specifically increasing depression.
“Women are certainly not happier in today’s sex-saturated environment,” Orient said. “Mental health is at an all-time low. We really don’t know the long-term consequences of constant suppression of women’s normal physiology for years. Over-the-counter oral contraceptives are for social engineering, not public health.”
Funding Conflict of Interest
The FDA is allocating resources to supporting initiatives like “rumor control,” and over-the-counter birth control, while contaminated medications continue to pour into the U.S. from overseas, finding their way to consumers.
“The FDA is getting the majority of its funding from pharmaceuticals,” Raviele said. “I think the focus is getting drugs out and convincing the public they are safe and effective. I don’t think it’s critically looking at drugs, the majority of which are coming to this country from China. They need to end their conflict of interest with the pharmaceuticals.”
Recalling over-the-counter drugs is difficult, “but I don’t think [Opill] will be a popular drug after the first few years,” Raviele added.