Last updated on: 12/19/2018 | Author: ProCon.org

History of OTC Birth Control

Of the 72.2 million American women of reproductive age, 64.9% use a contraceptive. Of those, 9.1 million (12.6% of contraceptive users) use birth control pills, which are the second most commonly used method of contraception in the United States after female sterilization (aka tubal ligation or “getting your tubes tied”). [119] The Pill is currently available by prescription only, and a debate has emerged about whether the birth control pill should be available over-the-counter (OTC), which means the Pill would be available along with other drugs such as Tylenol and Benadryl in drug store aisles. Since 1976, more than 90 drugs have switched from prescription to OTC status, including Sudafed (1976), Advil (1984), Rogaine (1996), Prilosec (2003), and Allegra (2011). [80]

Proponents say making the birth control pill available over-the-counter would lower teen pregnancy rates, provide contraceptive access to medically underserved women, and ease access to a health-improving drug with decades of safe use.

Opponents say making the Pill over-the-counter would raise the cost of contraception for women, pose a danger to teens’ and women’s health by removing the doctor’s visit requirement, and limit what options are made available.

Early Birth Control

Before the Pill, contraception came in many forms, from condoms to spermicides to cervical caps to the withdrawal method. The use of condoms as contraception dates back to approximately 3000 BC, when they were made from fish bladders, animal intestines, linen, or other materials. [81] The Petrie Papyrus, the first guide to contraception written around 1850 BC, suggested vaginal suppositories made of crocodile dung and gum or a honey mixture. [82] Around 1500 BC, the first spermicides appeared, which required soaking linen condoms in a solution and drying them before use. [81] In the 4th century BC, Aristotle wrote about women using olive oil as a contraceptive. [82] Women in preindustrial West Africa used plugs made of crushed roots, Japanese women used bamboo tissue, women of Easter Island used algae and seaweed. [82]

By the 1870s, mail-order catalogs like Sears and Roebuck, pharmacies, and rubber vendors sold cervical caps, condoms, diaphragms, douching syringes and solutions, and vaginal sponges. [82] Journalist Lisa Fogarty noted, “Some of the most popular birth control methods and devices in the 1910s included spermicides, douches, an early diaphragm called the Dutch pessary, and ergot pills, which induced abortions.” [83]

sears catalog 1908 syringe and hot water bottle
An ad for a vaginal douche in the 1908 Sears catalog. Although commonly used as birth control, the douche method could not be advertised as such due to the Comstock Act.
Source: Therese ONeill, “11 Female Health Products from the 1908 Sears Catalog,” mentalfloss.com

Margaret Sanger from 1914 Birth Control Pamphlet to 1942 Formation of Planned Parenthood

In 1914, Margaret Sanger revolutionized the birth control debate by distributing a 16-page pamphlet, “Family Limitation,” that included technical information about preventing pregnancy and a political statement about women’s right to have and use birth control. [84] Sanger opened the first birth control clinic in the United States on Oct. 16, 1916 in Brooklyn. [81] The clinic offered information from trained nurses on birth control, how to use it, and how the reproductive system works. [81] [85]

On Nov. 16, 1916 Sanger was arrested and convicted of violating the 1873 Comstock Act, which prohibited all information and ads about contraception; it also banned birth control from being sent through the US Postal Service or distributed across state lines. [81] [86] [87] Judge Frederick E. Crane upheld Sanger’s conviction in 1918, but he also ruled that contraception prescribed by doctors was legal. [87] [88] [89]

The Crane decision led to Sanger’s 1921 founding of the American Birth Control League and the 1923 opening of the first legal birth control clinic in the United States, the Clinical Research Bureau (later renamed the Birth Control Clinical Research Bureau) in Manhattan, which, by the 1930s, was serving over 10,000 patients a year and training thousands of doctors and nurses. [89] Most medical professionals, well into the 1960s, were not trained about reproduction, much less contraception. [82] [90] By 1929, New York had nine other clinics and the United States had 29 total. [91] In 1930, Sanger opened a clinic in Harlem, staffed by a black doctor, that had the support of W.E.B. Dubois. [90]

By Apr. 20, 1938, there were over 350 birth control clinics in the United States. [92] The birth control industry reported annual sales of over $250 million and Fortune magazine declared the industry one of the most prosperous of the decade. [82] Birth control laws varied from state to state: 21 states had legal birth control, but all other states had laws limiting or outright outlawing contraception. [92]

Planned Parenthood was founded in 1942 when the American Birth Control League and the Birth Control Clinical Research Bureau joined forces. [93]

Invention and Rise of the Pill

In 1950, Margaret Sanger began funding the development of a birth control pill. [90] Reliable birth control could be hard to get at the time. Diaphragms required a doctor’s prescription and doctors normally required that the woman be married to obtain one. Abortion was illegal and dangerous. And quacks with questionable herbs and contraptions were plentiful. [90] With Gregory Goodwin Pincus and staff doing the research, Catholic doctor John Rock helping with medical trials, and additional funding from Katharine McCormick and drug manufacturer G. D. Searle, the birth control pill was developed. [90]

Margaret Sanger, Gregory Goodwin Pincus, and John Rock
From left to right: Margaret Sanger, Dr. Gregory Goodwin Pincus, and Dr. John Rock
Sources: Library of Congress, “Margaret Sanger,” wikipedia.org, 1922
Wikipedia.org, “Photograph of Image of Dr. Gregory Goodwin Pincus (April 9, 1903-August 22, 1967),” wikipedia.org, Oct. 6, 2017
Mass Moments, “Mar. 24, 1890 Birth Control Pioneer Born,” massmoments.org (accessed Dec. 4, 2018)

The development of the Pill wasn’t without controversies. Sanger courted and obtained the financial and advocacy support of racist eugenicists for her project. [90] [94] The drug was also tested in Puerto Rico and Haiti using methods that were questionable at the time and would not meet modern ethical standards. [90] [84]

On June 10, 1957, the Food & Drug Administration (FDA) approved Enovid, known thereafter as simply “The Pill,” for infertility and menstrual irregularities. [90] The FDA required that Enovid include a warning that contraception could be a side-effect of the medication. [90] I.C. Winters, a G.D. Searle employee involved in the process said, “It was like a free ad” because the Pill was being used off-label for contraception anyway. [90]

Wagner sketch for pill compact
David P. Wagner’s sketch for a Pill dispenser, dated Mar. 10, 1962
Source: Diane Wendt and Mallory Warner, “Packaging the Pill,” americanhistory.si.edu, June 19, 2015

The FDA approved Enovid again on May 9, 1960–this time for contraceptive use, making it the first FDA-approved contraceptive drug and the first FDA-approved drug that does not treat an illness. [81] [85] [90] Within a year of its approval, 400,000 women (0.4% of the US female population) were taking the Pill for birth control, a number that increased to 1.2 million (1.3%) the next year, and to almost 6.5 million (6.6%) by 1965. [90] [95]

In the early 1960s, David P. Wagner of Geneva, Illinois, distrusted that his wife Doris was taking the pill correctly. [90] To solve this problem, he drew a calendar on paper and laid each pill out by day, which worked for the Wagners until the paper fell off the dresser. [90] In 1962, Wagner applied for a patent for the circular pill dispenser still common today. [90]

Birth Control Boom and Two Key Supreme Court Cases

In Griswold v. Connecticut (1965), the US Supreme Court ruled that the right of married couples to use birth control was protected under the Constitution’s right to privacy. This ruling did not affect the millions of unmarried women in the 26 states that still prohibited birth control. [81] [85] [96]

The FDA’s approval of the Pill for contraceptive use in 1960 opened the doors the approval of other birth control methods including IUDs (intrauterine devices) such as Lippes Loop and Copper 7. [81] [85] In 1968, Dalkon shields were introduced but, after 200,000 lawsuits filed on behalf of women who were injured or died as a result of use, the Dalkon shield was taken off the market in 1974. [97] Uncertainty about the safety of birth control methods was fairly common, and the 1970 Nelson Hearings were held in Congress to address the concerns. [81] [85] While no women were allowed to testify during the hearings, the formulation of the Pill was changed and the first package insert was required to inform women of side-effects and health risks. [81] [85]

Apr 7 1967 cover of Time Magazine
The Apr. 7, 1967 cover of TIME magazine featured the birth control pill. The article stated the Pill had “changed and liberated the sex and family life of a large and still growing segment of the U.S. population.”
Source: Lily Rothman, “50 Years Ago This Week: How Birth Control Changed Everything,” time.com, Apr. 3, 2017

In 1972, with the Baird v. Eisenstadt ruling, the US Supreme Court legalized birth control for everyone, regardless of marital status. [81]

The birth control market exploded. Low-dose hormone Pills were introduced in the 1980s, as were copper IUDs. The 1990s brought the first contraceptive implant, Norplant; the injectable DepoProvera; a female condom, FC1/Reality; and Plan B, emergency contraception. [81] [85]

By 1998, 31% of women who used contraceptives used the Pill, a number that had dropped to 27% by 1995 with increased condom use amid fears of HIV and other STIs (sexually-transmitted infections). [98]

The 2000s saw even more birth control options: the IUD Mirena, hormonal patch Ortho Evra, vaginal ring Nuvaring, female sterilization Essure, rod implant Implanon, and female condom FC2 were released on the market. [81].

On Mar. 23, 2010, President Obama signed the Affordable Care Act, which stated contraception is a form of preventative care and would be available without a copay, making most forms of birth control free to women with insurance. [85] On June 30, 2014, the US Supreme Court ruled in Hobby Lobby v. Burwell that corporations run by religious families cannot be required to provide contraception coverage. [99] The May 16, 2016 US Supreme Court ruling on Zubik v. Burwell (also known as the Little Sisters case) stated that religious institutions could be exempt from providing birth control coverage to employees. [100]

Who Uses the Pill

In the United States, female sterilization is the most popular form of birth control with 19.6% of the female population between 15 and 49 years old getting the procedure. [119] The second most popular is the Pill at 12.6%, followed by long-acting reversible contraceptives (LARCs; 10.3%) and male condoms (8.7%). [119] CDC surveys found that white, college educated childless women 20-29 years old with higher incomes and private insurance were more likely to use the Pill. [2] [119]

Women between 35 and 44 use contraception at higher rates than younger women, and account for over a third of birth control use of women aged 15 to 44. [2] While 49.2% of women 15 to 24 years old used the pill, that percentage dropped to 17.0% for women between 35 and 39 years old and 9.8% for women 40 to 44. [2] 49% of women who had not given birth used the Pill, compared to 12% of women who had given birth to two or more children. [2] The most popular form of contraception for women over 35 was female sterilization, followed by male sterilization. [2]

The CDC found that 21% of white women used the pill, in comparison to 12.3% of Asian women, 11.8% of Hispanic women, and 9.9% of black women. 35% of women with a bachelor’s degree used the Pill, in contrast to 11% of women with a high school diploma. [2] Hispanic women, whether US or foreign born, and black women were more likely to use female sterilization, while Asian women used condoms most frequently. [2]

Prescription status of birth control pills around the world
Of 135 countries for which data are available, 96 countries representing 80.33% of the global population have OTC birth control access

Globally, the Pill is not as popular as it is in the United States. The United Nations found that, of women who are married or in domestic partnerships worldwide, 8.8% used the birth control pill (compared to 16% in the United States), 19.2% used female sterilization, 13.7% used an IUD, and 7.7% used male condoms. [116] The Pill is most popular in Europe with 21.9% of women who are married or in domestic partnerships and Oceania with 21.6%. [116] The birth control pill is the second most popular form of contraception in Africa (8.7%), Latin America and the Caribbean (15.0%), and Northern American (16.5%). [116] In Asia, the Pill ranks fourth with 6.4% of women who are married or in domestic partnerships using the method. [116]

How the Pill Works

There are two kinds of birth control pills: Minipills (or POPs), which contain only progestin, and combination Pills, which contain progestin and estrogen. [111] [112] In Minipills and combination pills, progestin thickens the mucus in the cervix (making it difficult for sperm to enter the uterus), suppresses ovulation, and thins the lining of the uterus, all of which helps prevent pregnancy. [113] [112] The Mayo Clinic states minipills are often recommended for those who are breastfeeding, who have certain health problems (such as blood clots), and who are concerned about the side effects of estrogen. [112] Risks and side effects of the minipill include unintended pregnancy (as many as 13 out of 100 users became pregnant in the first year of use), acne, irregular menstrual bleeding, depression, and decreased libibo, among others. [112]

Unlike Minipills, the combination Pill also causes the body to maintain high levels of estrogen, which, when combined with progestin, lowers the levels of two other hormones (follicle-stimulating hormone (FSH) and luteinizing hormone (LH)), which in turn prevents the release of eggs for fertilization. [114] The Mayo Clinic states that combination pills are recommended for more predictable menstrual cycles, relief from premenstrual syndrome (PMS) and menstrual cramps, acne, and decreased risk of ovarian and endometrial cancers and heavy menstrual bleeding. [115] Risks and side effects of the combination pill include headaches, nausea, blot clots, and heart attacks, among others. [115]

FDA Path to OTC Status

For all prescription to OTC switches, the drug manufacturer requests a review of the drug’s active ingredient(s) and the dosage, rather than all of the drug’s ingredients, such as those for coloring, for example. For a prescription drug to move to over-the-counter status, two paths can be taken by the drug manufacturer. [117] [118] In one option, the manufacturer submits an “OTC drug review” to the FDA asking for OTC status consideration. In the OTC drug review, groups of non-government experts review the active ingredients in the prescription drug to determine if they are safe for OTC use. [117]

 

Drugs switched from Rx to OTC
Common drugs that have switched from prescription status to OTC status.

In the second option, the manufacturer submits new information via the new drug application process. In this option, the manufacturer submits studies showing the label can “be read, understood, and followed by the consumer without the guidance of a health care provider,” along with other information such as additional safety studies. [117]

In both methods, if a drug is the first of its category to be switched to OTC status the FDA asks a joint advisory committee that includes experts on that type of drug. The FDA then weighs the safety of the drug, whether consumers can follow the label directions without help, whether patients can diagnose themselves for the condition the drug treats, and whether the condition requires a medical exam or lab tests to use the drug over time. [117] More than 90 drug ingredients and dosages have been moved from prescription to over-the-counter status since 1975. [118]

Efforts to Move Birth Control Pills OTC

A Feb. 23, 1993 scheduled FDA hearing on making the Pill over-the-counter was canceled just one week after it was announced. The meeting was partially organized by R.W. Johnson Pharmaceutical Research Institute, the research arm of Ortho Pharmaceutical Corporation that makes Ortho Novum, the best-selling Pill at the time. The FDA stated that the meeting was canceled because the agenda was not broad enough. [101] [102]

In 2006, Plan B, an emergency contraceptive that prevents pregnancy up to five days after sex, was approved for OTC sales to women 18 and older, after a years-long battle. [101] Opponents included conservative members of Congress and organizations like the Family Research Council, which stated, “We think this is putting women’s health at risk.” [103] On June 20, 2013, the FDA approved Plan B One-Step for unrestricted OTC sales. The generic version was approved on Feb. 25, 2014 for unrestricted OTC sales. [81]

Plan B One-Step
Plan B One-Step
Source: Patti Neighmond, “The Morning-After Pill: How It Works and Who Uses It,” npr.org, Feb. 6, 2012

In Dec. 2012, the American College of Obstetricians and Gynecologists became the first major medical organization to endorse over-the-counter birth control pills, stating: “Weighing the risks versus the benefits based on currently available data, OCs [oral contraceptives] should be available over-the-counter.” [104]

After the 2012 election, some Republican lawmakers, including then-Governor of Louisiana Bobby Jindal, promoted the idea of over-the counter birth control pills as an alternative to the Obamacare mandate that birth control be provided for free to insured women [105] In 2015 Senators Cory Gardner (R-CO) and Kelly Ayotte (R-NH) proposed a bill to incentivize manufacturers to submit applications for OTC status to the FDA for women over 17-years-old, including fast-track options and waiving the $1 million filing fee. [106] [107] A bill proposed by Senator Patty Murphy (D-WA), also in 2015, would have required that health insurance cover OTC birth control pills. [107] Neither bill passed, and similar bills in subsequent years also stalled in Congress. [108] [109]

On Dec. 2016, Ibis Reproductive Health and HRA Pharma stated they would take the necessary steps to apply for OTC status for a birth control pill in the United States. [110]