Over-the-Counter Insurgency
News: The FDA, in a surprise move, is considering allowing Plan B to be sold without a prescription. Herewith, a timeline of emergency contraception’s long and faltering journey from one side of the counter (almost) to the other.
August 1, 2006
Since the U.S. Food and Drug Administration (FDA) agreed to review Plan B for over-the-counter (OTC) sale in June 2003, the agency has gone to unprecedented lengths to avoid issuing a decision. Details of the FDA’s “unusual” delay were released in a report by the Government Accountability Office (GAO) earlier this month, painting the clearest picture yet of how the agency officials have routinely allowed politics to trump science.
But the FDA’s action (or inaction) on Plan B is only one aspect of the broader struggle over access to emergency contraception (EC). In the three years the agency has been considering Plan B for over-the-counter status, activists on both sides have filed lawsuits, states have passed legislation regarding pharmacists' right to refuse to dispense contraception, major medical organizations have weighed in, and more than 14 million unplanned pregnancies have occurred.
Herewith, a timeline of emergency contraception’s long journey from one side of the counter (almost) to the other.
FDA Actions
Research
State Legislative Actions
Federal Legislative Actions
Litigation
Anecdotes/Misc.
- 5/11/60
The U.S. Food and Drug Administration (FDA) approves the first oral contraceptives for marketing in the United States. It becomes common for doctors to prescribe a combination of oral contraceptive pills for "off-label" use as EC.
- 2/25/97
FDA declares that six brands of oral contraceptive pills, when used in a specific way, can be safe and effective EC. READ IT
Pre-existing pharmacy regulation laws in Washington state allow for direct pharmacy access to EC, without a prescription.
- 9/1/98
FDA approves Preven (now off the market) EC for use with a prescription. READ IT
- 4/99
Wal-Mart announces it will not sell EC in its approximately 2,400 pharmacies, citing "a variety of business considerations."
- 7/28/99
FDA approves Plan B as a prescription form of EC. READ IT
- 10/00
The French Parliament passes legislation granting school nurses the right to dispense EC in both junior high and high schools.
- 12/00
The American Medical Association announces its support for OTC availability of EC. READ IT
- 2/14/01
The American College of Obstetricians and Gynecologists issues a statement supporting EC for OTC status. READ IT
- 2/14/01
More than 70 medical, public health, and other organizations file a citizens' petition asking the FDA to grant OTC status to EC. The FDA will wait five years before issuing an official denial of the petition. READ IT
- 2/23/01
California passes legislation making EC available from a pharmacist without a prescription. READ IT
- 5/01
The Journal of Adolescent Health publishes a study that shows that teens who receive advance provision of EC are more likely to use it, and their use of condoms does not decrease after having the pills at home.
- 6/5/02
Top FDA officials meet to discuss the expected application to make Plan B available OTC.
- 4/25/02
Alaska's pharmacy board approves a protocol enabling pharmacists to dispense EC in collaboration with a licensed prescriber. READ IT
- 9/23/02
FDA officials meet and discuss "behavioral issues in adolescents" and the possibility of a behind-the-counter option or an age restriction.
- 12/02
New Mexico's pharmacy board allows pharmacists to provide EC without a prescription.
- 12/02
Analysis by the Alan Guttmacher Institute shows that EC has played a key role in abortion rate declines between 1994 and 2000. In 2000 alone, AGI estimates that EC averted as many as 51,000 abortions.
- 2/03
A study published in the Journal of Adolescent Health shows that teenage girls with increased access to EC were not more likely to report having unprotected sex. READ IT
- 4/16/03
Women's Capital Corporation (maker of Plan B) requests permission from the FDA to make EC available OTC. The application contains 15,000 pages of data, spanning 59 volumes, and includes research from 39 clinical studies.
- 5/21/03
FDA Commissioner Mark McClellan discusses the pending Plan B application with a White House domestic policy official. READ IT
- 6/9/03
FDA's Office of Drug Evaluation agrees to review Plan B for OTC sale, and sets a goal date of February 22, 2004, to reach a decision.
- 6/24/03
Hawaii enacts legislation to allow pharmacists to dispense EC without a prescription. READ IT
- 9/5/03
California law requires hospitals to offer EC to rape survivors.
- 10/1/03
New York state requires hospitals to offer EC to rape survivors.
- 12/8/03
Rep. Joseph Pitts, along with 43 other Republicans in Congress, including Majority Leader Tom DeLay, send letter to the FDA urging it to reject Plan B for OTC status.
- 12/16/03
Members of the FDA independent joint advisory committee vote 23 to 4 to recommend approving Plan B for OTC sale. Members also vote 27 to 1 that Plan B can be safely used—even by adolescents—as recommended by the label. READ IT
- 12/16/03
Dr. W. David Hager, one of the four FDA committee members who voted against Plan B approval for OTC sale, tells the New York Times: "What we heard today was frequently about individuals who did not want to take responsibility for their actions and wanted a medication to relieve those consequences."
- 12/29/03
Tony Perkins of the conservative Family Research Council declares that making Plan B available OTC "would make the morning-after pill the new Saturday night party favor of choice." READ IT
- 1/15/04
The FDA Commissioner's office recommends that the Office of Drug Evaluation not approve OTC sale.
- 1/21/04
The Office of Drug Evaluation concludes Plan B is safe for OTC sale.
- 1/30/04
Rep. Carolyn Maloney, along with 75 other members of Congress, from both parties, send a letter to FDA Commissioner McClellan expressing support for the expert panel's recommendation to grant Plan B OTC status. READ IT
- 2/2/04
FDA Office of Drug Evaluation staff ask for more data about Plan B and adolescents.
- 2/13/04
FDA extends the goal date for a decision to May 21, 2004.
- 2/18/04
Office of Drug Evaluation recommend Plan B for unrestricted OTC sale. The Commissioner asks for a marketing plan that would limit the availability of Plan B OTC, and asks for consideration of "the most appropriate ages that should be restricted from OTC access."
- 2/04
A Denton, Texas, pharmacist refuses to fill a rape survivor's prescription for EC, citing "religious convictions."
- 2/26/04
Barr Pharmaceuticals completes acquisition of marketing rights for Plan B from Women's Capital Corporation.
- 3/22/04
Maine makes EC available through a pharmacist without a prescription. READ IT
- 3/23/04
An internal memo quotes FDA medical official Janet Woodcock as saying the OTC availability of Plan B could lead to “extreme promiscuous behaviors such as the medication taking on an ‘urban legend’ status that would lead adolescents to form sex-based cults centered around the use of Plan B.”
- 4/2/04
FDA's Office of Drug Evaluation issues its review recommending Plan B for OTC sale, without age restriction.
- 4/04
A University of Pittsburgh study finds providing advance EC to adolescents is not associated with more unprotected sex or less condom use. Adolescents provided with advance EC are nearly twice as likely to use it and began EC sooner, when it is known to be more effective. READ IT
- 4/22/04
FDA's Office of New Drugs issues its review recommending Plan B for OTC sale, without age restriction.
- 5/5/04
Dr. Steve Galson, acting director of the FDA's Center for Drug Evaluation and Research, rejects the recommendations of the joint advisory committee and denies Plan B OTC marketing status, "citing a lack of adequate data regarding safe use among younger adolescents." READ IT
- 5/17/04
Several members of Congress send letter to the Government Accountability Office requesting an investigation of FDA for its decision. Rep. Maloney introduces the Science Over Politics Act, which requires the FDA commissioner to review his prior decision on Plan B within 30 days and affirm 1) that his decision was not politically influenced, 2) that it was based on sound science, and 3) that it conformed to FDA precedent and procedures. READ IT
- 6/16/04
Galson, the FDA's drug evaluation chief, says that he made the decision to reject the Plan B application on his own and did not follow the recommendations of his staff. READ IT
- 7/13/04
The House passes an amendment to the FY05 Agriculture Appropriations bill to require the FDA to determine what is safe and effective contraception. The amendment survives the conference committee and is included in the Omnibus Appropriations Conference Report of November 20, 2004.
- 7/22/04
Barr Laboratories submits a revised "dual-label status" proposal that would make Plan B available without a prescription only to women aged 16 and older. Women 15 and younger would continue to need a prescription.
- 8/04
Barr stops manufacturing Preven, leaving Plan B as the only brand of EC on the market.
- 10/29/04
Hager delivers a speech at Kentucky's Asbury College in which he says he was asked to send the FDA commissioner a minority opinion on his decision to vote against OTC status for Plan B. Hager says of his opinion, "I argued it from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision." [From The Republican War on Science by Chris Mooney, p. 218-219.] READ IT
- 1/05
Galson plans to issue a letter approving Plan B for OTC status for women 17 years and up, but Crawford removes Galson’s authority to decide on the Plan B application. Galson later testifies that Crawford was “concerned about where we were heading because he knew that I was heading towards this recommendation.” READ IT
- 1/5/05
The Journal of the American Medical Association publishes a study that shows increased access to EC does not lead to an increase in pregnancy rates, an increase in unprotected sex, or cause women to give up their regular birth control. READ IT
- 1/7/05
Nine activists are arrested outside FDA headquarters after they demand to speak with Galson, head of the FDA's Center for Drug Evaluation and Research, about the agency's rejection of Plan B for OTC status. READ IT
- 1/13/05
The Department of Justice issues its first-ever medical guidelines for treating rape victims, which exclude any mention of EC. (Earlier drafts had contained references to EC.) A bipartisan group of 96 representatives urges the Justice Department to include the option of EC in the protocol. READ IT
- 1/15/05
Sens. Jon Corzine, Hillary Clinton, and Olympia Snowe introduce legislation to require hospitals to provide EC to rape victims. READ IT
- 1/19/05
More than 50 members of Congress send a letter to FDA Acting Commissioner Lester Crawford expressing support for Barr Laboratories' making Plan B available OTC to women ages 16 and older.
- 1/21/05
The Center for Reproductive Rights files a lawsuit in federal court against the FDA acting commissioner for failing to approve Plan B for OTC status. READ IT
- 2/05
Two women in Chicago report that a pharmacy turned them away when they tried to fill prescriptions for EC.
- 3/17/05
Lester Crawford is confirmed as FDA Commissioner. During his confirmation hearings, he says of the Plan B decision process, "The science part is generally done. We're just now down to what the label will look [like]. This is going to be a very unusual sort of approval." READ IT
- 4/6/05
Sens. Patty Murray and Hillary Clinton place a "hold" on Crawford's confirmation as commissioner until the FDA takes action on Plan B. READ IT READ IT
- 4/19/05
Canada's National Health Agency approves EC for sale without a prescription. READ IT
- 4/05
The Illinois Department of Financial and Professional Regulation files a formal complaint against the Chicago pharmacy that denied women EC. READ IT
Gov. Rod Blagojevich signs an emergency rule—later made permanent—to prohibit pharmacies from refusing to fill a lawful contraceptive prescription. "No delays. No hassles. No lectures," he says. READ IT
- 4/14/05
Reps. Steve Israel and Maloney and 118 co-sponsors call for passage of the Access to Legal Pharmaceuticals Act (ALPhA), which would require pharmacies to fill all prescriptions without delay or harassment, even if an individual pharmacist refuses to do it. READ IT READ IT
- 5/26/05
At a White House Press Briefing, spokesman Scott McClellan declines to answer whether President Bush supports birth control. READ IT
- 6/7/05
An Illinois pharmacist files a lawsuit challenging Gov. Blagojevich's rule requiring all pharmacists to fill prescriptions for contraceptives. READ IT
- 6/16/05
New Hampshire makes EC available without a prescription. READ IT
- 7/15/05
Sens. Patty Murray and Hillary Clinton lift the "hold" on Crawford's nomination after Health and Human Services Secretary Mike Leavitt promises that the FDA will act on the Plan B application by September 1. READ IT
- 7/18/05
At a White House Press Briefing, spokesman Scott McClellan declines to answer whether President Bush supports birth control. READ IT
- 7/25/05
The House Small Business Committee holds hearings in response to Illinois Gov. Blagojevich's rule requiring all pharmacies to fill prescriptions for contraceptives, after several pharmacists file a lawsuit challenging the rule. READ IT
- 7/25/05
Massachusetts Gov. Mitt Romney vetoes legislation that would have allowed pharmacists to dispense EC without a prescription. Romney writes in a Boston Globe op-ed that he vetoed the bill because he considers EC a form of abortion, but "I have not attempted to impose my own views on the pro-choice majority [in Massachusetts]." READ IT
- 8/5/05
New York Gov. George Pataki vetoes a bill that would have made EC available to women of all ages by a pharmacist, without a prescription. READ IT
- 8/26/05
FDA announces it will not make a decision by September 1, instead it will wait for a 60-day public comment period, with no specified deadline for a decision. READ IT READ IT The FDA changes the age limit to women 17 and older, rather than 16.
- 8/31/05
Dr. Susan Wood, director of the FDA's Office of Women's Health, resigns in protest over the agency's handling of the Plan B application. READ IT The agency initially replaces her with Norris Alderson—a veterinarian—but later that day says Theresa A. Toigo will be the new acting director. READ IT READ IT
- 9/1/05
The American Academy of Pediatrics publishes a statement in support of making EC available OTC to teens and young adults. READ IT
- 9/2/05
Thirteen senators ask the GAO to release its findings on the FDA's approval process. READ IT
- 9/6/05
A 21-year-old New Hampshire woman is denied EC. The pharmacist says he is morally opposed to filling the prescription and refuses to refer her to another pharmacy. READ IT
- 9/15/05
The Massachusetts state legislature overrides Gov. Romney's veto of legislation to create greater access to EC. Massachusetts is the eighth state to allow pharmacists to dispense EC without a prescription. READ IT
- 9/23/05
FDA Commissioner Lester Crawford resigns. Andrew Von Eschenbach is named Acting Commissioner. READ IT
- 9/30/05
A pharmacist at a Target store in Fenton, Missouri, refuses to fill a 26-year-old woman's prescription for EC. Several pro-choice advocacy groups launch letter-writing campaigns to protest the company's policy. READ IT
- 10/7/05
Dr. Frank Davidoff, a member of the FDA's Nonprescription Drug Advisory Committee, resigns to protest the delayed decision on Plan B. READ IT
- 10/12/05
The GAO releases a preliminary draft of its report regarding Plan B, and reveals that former FDA Commissioner Lester Crawford refused to cooperate with its investigation. READ IT
- 10/25/05
At a White House Press Briefing, spokesman Scott McClellan again declines to answer whether President Bush supports birth control. READ IT
- 11/1/05
The 60-day public comment period expires. The FDA has received more than 10,000 comments. READ IT READ IT
- 11/3/05
Reps. Maloney, Shays, Inslee, and Crowley introduce "Plan B for Plan B Act of 2005," which would require the FDA to either approve or deny OTC status for Plan B. READ IT
- 11/14/05
GAO releases its report on the FDA's Plan B decision process, finding that the failure to approve Plan B for OTC use was highly unusual, made with atypical involvement from high-level agency officials, and likely was made months before the formal announcement. READ IT Several members of Congress call on Secretary of Health and Human Services Michael Leavitt to release information missing from the GAO report. READ IT
- 11/15/05
Rep. Henry Waxman (D-CA) requests a House government reform committee meeting on the FDA's failure to act on Plan B, calling it "an egregious example of the politicization of science." READ IT
- 11/21/05
Kathleen Uhl is named director of the FDA’s Office of Women’s Health. READ IT
- 11/29/05
A Michigan lawmaker introduces a bill that would ban all nonprescription sales of EC. READ IT
- 12/22/05
A New York court hears oral arguments in the Center for Reproductive Rights' lawsuit against the FDA. READ IT
- 1/24/06
A San Antonio TV station reports that U.S. women are crossing the border to buy EC from pharmacies in Mexico, where it is sold OTC. READ IT
- 3/3/06
Wal-Mart announces that all of its pharmacies will stock Plan B. A spokesman says, “It is difficult to justify being the country‘s only major pharmacy chain not selling it.” Wal-Mart pharmacists, however, are still not required to fill EC prescriptions. READ IT
- 3/15/06
The state of Wisconsin files documents seeking to join the Center for Reproductive Rights’ lawsuit against the FDA. READ IT
- 3/28/06
Senators Clinton and Murray meet with von Eschenbach, but are unable to get a Plan B update. They vow to block his confirmation until the FDA makes a decision about Plan B. READ IT
- 5/8/06
The American College of Obstetricians and Gynecologists launches a campaign encouraging women to get advance prescriptions of EC from their OB/GYN. READ IT
- 5/26/06
Responding to repeated inquiries from several members of Congress, Bush says he “supports the availability of safe and effective products and services to assist responsible adults in making decisions about preventing or delaying conception.” READ IT
- 6/4/06
A 42-year-old mother of two writes a Washington Post op-ed about how she was denied a Plan B prescription, ended up pregnant, and had an abortion. READ IT
- 6/9/06
The FDA denies the citizen's petition submitted by more than 70 medical and public health organizations in February 2001 because the groups do not have the standing to make the request and because the petition does not provide "sufficient data to satisfy the statutory requirements" needed to approve Plan B for OTC sale. READ IT
- 6/22/06
Rep. Maloney responds to Bush’s statement in support of contraception with a request that he support FDA approval of OTC status for Plan B. READ IT
- 7/1/06
Currently, 8 states require emergency rooms to provide information about EC, and 7 states require ERs to dispense EC upon request to sexual assault survivors. Nine states allow pharmacists to dispense EC under certain conditions without a doctor’s prescription. Eight states have adopted various restrictions on EC. READ IT
- 7/31/06
The FDA, in a surprise move, offers a proposal to allow Plan B to be sold without a prescription to women age 18 and older. READ IT
- 8/1/06
At his Senate confirmation hearing, acting FDA Commissioner von Eschenbach says the preliminary move to make Plan B available OTC to women over 18 was not based on “political ideology,” but rather on his own “medical ideology.” He also said 18 was a good age restriction partly because that is the age at which it’s legal to buy cigarettes, so it would be an easy age for pharmacists to remember. READ IT READ IT. Sen. Patty Murray provided an August 2005 letter from former FDA Commissioner Lester Crawford that said agency researchers found the drug safe and effective for 17-year-olds. She and Sen. Hillary Clinton maintain that they will block von Eschenbach’s confirmation until the FDA issues a decision on Plan B.
Ann Friedman is a senior editorial fellow at Mother Jones.
