Religious Right Works to Limit Access to Plan B, "Morning-after" Contraceptive
Topics on this page: Push for action on Plan B | Availability of Plan B | 2007: Religious right pushes state legislation against Plan B | Lawsuit against Bush administration | The FDA's politicized process on Plan B application. | Wal-Mart forced to sell Plan B. | Campaign to make Target sell Plan B | April 2007: Washington State law requires pharamcies to stock and dispense Plan B | Religious Right groups sue FDA to overturn its approval of Plan B
Pill Patrol: Planned Parenthood campaign to combat pharmacist refusal
March 2007: Identify pharmacies in your neighborhood that won't provide emergency contraception and take action with Planned Parenthood. Download the Activist Toolkit here (a PDF document) or click here to sign up.
FDA Sued For Politicizing Women's Health
by Elizabeth Gettelman, Mother Jones' Blue Marble Blog, April 13, 2007
Here's a new one: The Family Research Council is accusing the FDA of "politicizing women's health." Because before Plan B came around a woman's body was her own business? Right.
Yesterday a coalition of groups including the Family Research Council and Concerned Women for America filed a lawsuit against the FDA for its decision to approve the nonprescription sales of Plan B, Barr Laboratories' emergency contraceptive. Continue.
Family groups sue FDA over contraceptive
By Amy Fagan, The Washington Times via Pewforum.org, April 13, 2007
The Family Research Council and other groups yesterday sued the U.S. Food and Drug Administration, seeking to overturn the 2006 decision that allowed over-the-counter distribution of the contraceptive Plan B also called the "morning-after pill."
Among its many complaints, the lawsuit -- filed in U.S. District Court -- accuses the FDA of violating the law by allowing the same drug to be distributed simultaneously by prescription and over the counter, and charges that the FDA's decision was made under improper political pressure from Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington state. Continue.
FRC Lawsuit Accuses FDA of Politicizing Women's Health
News release, Family Research Council via PRnewswire.com, April 13, 2007
WASHINGTON, D.C. - Yesterday, Family Research Council (FRC) and a coalition of groups including Concerned Women for America (CWA), American Association of Physicians and Surgeons (AAPS), and Safe Drugs for Women filed a federal lawsuit against the Food and Drug Administration (FDA) to overturn the FDA's approval of the "Plan B" morning-after pill for over-the-counter (OTC) use by women 18 and older. Continue.
Religious right lawsuit against the FDA
The case was filed in federal court in Washington DC on April 12th, by the Family Research Council, Concerned Women for America (CWA) and Safe Drugs for Women, which has the same address as CWA and American Physicians and Surgeons, Inc. Click here to read the complaint on the Family Research Council's site.
Women's Health: Plan B Is Now Behind the Counter
By Deborah Kotz, U.S. News & World Report, November 9, 2006
Broken condom? No worries. The over-the-counter emergency contraceptive Plan B is arriving in pharmacies this week and next. Approved for OTC use in August, Plan B is 89 percent effective at preventing pregnancy if taken within the first 72 hours of unprotected sex. According to the American College of Obstetricians and Gynecologists, nearly half of the more than 6 million pregnancies that occur each year are unplanned. The organization estimates that expanded access to Plan B could cut unintended pregnancies–and abortion rates–in half. Continue.
‘Morning After’ Pill Is Cleared for Wider Sales
By Gardiner Harris, The New York Times, August 24, 2006
WASHINGTON, Aug. 24 - The Food and Drug Administration today approved over-the-counter sales of the "morning after" contraceptive pill to those 18 and older, resolving one of the most contentious issues in the agency’s 100-year history.
The drug, an emergency contraceptive called Plan B that is manufactured by Barr Pharmaceuticals, will be sold only in pharmacies and health clinics. Buyers will have to show proof of age. Anyone under the age of 18 will still need a prescription to buy the pills. Continue.
Battle Plan B
Bonnie Erbe, ScrippsNews, August 29, 2006
Think the fighting's done over Plan B? You'd better have a Plan B, because it's far from over. Just because the Food and Drug Administration finally did most of what it should have done years ago _ it approved the "morning after" pill for sale without a prescription to women who are at least 18 _ doesn't mean this battle is behind us.
Religious groups and religiously motivated conservatives tried to pressure President Bush to fire the acting FDA commissioner who finally pushed through permission to sell Plan B over the counter without a prescription. Continue
Emergency Contraception OTC
Planned Parenthood Hails Expansion of Plan B Access, but Cites Concerns About Teen Pregnancy
News release, Planned Parenthood Federation of America, August 24, 2006
New York — Planned Parenthood Federation of America (PPFA) today hailed the decision by the U.S. Food and Drug Administration (FDA) to approve over-the-counter status for Plan B emergency contraception (EC) for women 18 and older. However, PPFA, the nation's leading sexual health care advocate and provider, expressed dismay at the scientifically baseless restrictions that deny teenagers over-the-counter access to the safe, effective method of backup birth control. Continue
What Comes After Plan B?
by Nancy Keenan, TomPaine.com, August 30, 2006. Nancy Keenan is president of NARAL Pro-Choice America, www.prochoiceamerica.org.
The recent approval of the Plan B emergency contraceptive for over-the-counter access by the Food and Drug Administration after a three-year delay marked a win for women’s health and sound science over political ideology.
Americans celebrate this victory because, apparently, President Bush and his advisers could no longer defend their opposition to this safe, effective form of birth control.
Despite the FDA’s actions, President Bush shouldn’t get any brownie points for this decision. Instead, the decision should remind Americans that his administration was responsible for holding the application hostage for more than three years. During this time, the Bush administration put politics ahead of sound science, denying, without merit, American women’s access to a safe, effective form of contraception. Continue
No Jewish backlash against Plan B
By Jacob Berkman, The Jewish Standard (Northern New Jersey), August 31, 2006
When the FDA last week approved the over-the-counter sale of Plan B, a post-intercourse oral contraceptive, conservative and right-wing Christian groups scored the move, but Jewish groups seem fairly nonplussed by the decision.
The "morning after" pill, which when taken within 72 hours of unprotected sex can reduce the chance of pregnancy, has been available by prescription for three years, but now will be available over the counter to anyone over 18. While right-wing groups looked at the move as one that will further loosen the country’s morals and could lead to a wider spread of AIDS through unprotected sex, Jewish groups — at least from a halachic point of view said that the pill itself poses few problems. Continue
SBC's Richard Land Calls Approval of Plan B "Sad Day for America"
Church Report, August 25, 2006
Dr. Richard Land, president of The Ethics & Religious Liberty Commission, commented on today’s approval by the Food and Drug Administration of Plan B for non-prescription sale to women 18 and older:
“It’s a sad day for America. Allowing drugs with such powerful physiological and emotional effects to be sold over the counter to adults without a prescription will have significant consequences, none of them good.
“I am fearful that many adult men will purchase Plan B and use it in the seduction of girls who are not yet 18 and who cannot purchase the drug for themselves. It will become part of the sexual predator’s seduction kit. People who dismiss this scenario are simply unaware of the facts about the current relationship and dating habits between men 21 and older and younger girls in the United States. Plan B will be used by sexually predatory men to assure young girls that no pregnancy will occur. Continue
Christian Groups Condemn Over-the-Counter Plan B
Michelle Vu, Christian Post, August 27, 2006
Christian groups ranging from public policy to medical doctors have responded to the FDA’s decision to make Plan B available without a prescription with grave concern and condemnation, opposing the administration’s new policy on the controversial drug.
“It’s a sad day for America. Allowing drugs with such powerful physiological and emotional effects to be sold over the counter to adults without a prescription will have significant consequences, none of them good,” said Dr. Richard Land, president of The Ethics & Religious Liberty Commission (ERLC), in a written statement after the drug’s approval. Continue
Plan B Supporters Won't Rest Until Age Restrictions are Dropped
Focus on the Family via the Baptist Missionary Association of Texas, August 28, 2006
Advocates of Plan B, also known as the morning-after pill, have vowed to fight age restrictions put in place by the Food and Drug Administration (FDA) when it announced last week the drug will be available over-the-counter for those 18 and older. Women and girls 17 and younger will still need a doctor's prescription to obtain the drug. Continue
Focus Says Plan B Decision a 'Disaster' and 'Dangerous'
Also, FDA's Move Puts Pro-Life Pharmacists on the Spot
Church Report, August 28, 2006
Focus on the Family, a prominent pro-life, pro-family ministry, is condemning this week's decision by the U.S. government to make the "morning-after" pill available without a prescription to anyone over the age of 18. Easy availability of the "emergency contraception," known as Plan B, will endanger the lives of young women, says a ministry spokesperson.
"This decision is a disaster and a danger for girls and their parents." That's the blunt and straightforward assessment from Carrie Gordon Earll, senior analyst for bioethics with the Colorado-based ministry. "There are no safeguards, legal or otherwise, to prevent this powerful drug from falling into the hands of teen girls -- or, worse, into the hands of men bent on sexually exploiting teen girls by flashing a magic pill as a promise that they won't have to worry about getting pregnant." Continue
Area pharmacists speak out on Plan B
By Cynthia T. Pegram, The News and Advance (Lynchburg, Virginia), August 27, 2006
By the end of the year, Plan B will be available for over-the-counter sales in many pharmacies across the nation.
In the Lynchburg area, local pharmacists will be making their own decisions about stocking the drug, which provides women with a second chance at preventing pregnancy if they missed the first chance. Continue.
FDA Decision on Plan B is Bad Medicine for Women
Christian News Wire, American Association of Pro Life Obstetricians and Gynecologists, August 28, 2006
The FDA’s recent decision to allow over-the-counter status for Plan B "emergency contraception" for women age 18 and over may be superficially appealing, but it is a step backward in women’s reproductive healthcare.
Despite assurances that this decision will lead to a reduction in unintended pregnancies and abortions in the United States, actual data demonstrate that even providing women free "emergency contraception" on hand at home has not made a difference in the unintended pregnancy or abortion rates of women. Going to a pharmacy to buy this medication is certainly less convenient than in study conditions. Therefore, it can reasonably be assumed that the results will be the same: no decrease in unintended pregnancy or abortion rates Continue
Bill would change immunization rules
by Kit Wagar, St. Louis Jewish Light, April 5, 2007
Treating and preventing many common illnesses used to be simple.
A doctor gave you a prescription, you took it to the drug store and a pharmacist filled the order. Childhood illnesses that devastated earlier generations had been zapped by vaccines for polio, mumps and chicken pox.
Not any more. With the rise of the religious right, many of the miracles of modern medicine — from children's vaccinations to birth control to emerging treatments derived through stem cell research — have become battlegrounds in the morality wars.
Bills have been filed this year that would cut off access to emergency contraception and allow pharmacists to refuse to fill a prescription if they had a moral objection to the medication. Continue.
Board requires pharmacies to fill all orders
Objections by druggists centered on Plan B drug
Seattle Post-intelligencer, April 12, 2007
TUMWATER -- After years of debate, the state has made it official: Patients must get prescriptions filled even if pharmacists are opposed to the drugs for religious or moral reasons.
The Washington State Board of Pharmacy voted unanimously Thursday to adopt a policy that applies to all kinds of medications, although it clearly was aimed at Plan B, a birth control measure that critics say is tantamount to abortion. Most health experts refute that claim.
Druggists with personal objections to a drug still could have a limited escape by getting a co-worker to fill an order. But that would apply only if the patient is able to get the prescription in the same pharmacy visit. Continue.
WA State: 'Morning After' Pill Can't Be Denied
By Curt Woodward, Associated Press, Christian Broadcasting Network, April 13, 2007
CBNNews.com -- SEATTLE -- Druggists who believe "morning-after" birth control pills are tantamount to abortion can't stand in the way of a patient's right to the drugs, state regulators have decided.
In a unanimous vote Thursday, the state Board of Pharmacy ruled that drug stores have a duty to fill lawful prescriptions despite an individual pharmacist's personal objections to any particular medication. Continue.
Washington Pharmacy Board Approves New Rules With No Conscience Clause
by Steven Ertelt, LifeNews.com, April 12, 2007
Olympia, WA (LifeNews.com) -- The Washington state pharmacy board has approved new rules require pharmacists to fill all legal prescriptions for drugs. The rule would apply even if the pharmacist objects to the drug on the grounds that it could cause an abortion or for other moral or religious reasons. Continue.
Dispute over Plan B pill gives birth to education
Susan Paynter, Seattle Post-Intelligencer, April 8, 2007
The labor pains have been protracted in delivering full, unfettered access to the Plan B "morning after" pill to women in this state.
The already postponed decision expected March 30 from the Washington State Board of Pharmacy on the dispensing of these and other pills -- regardless of possible objections by druggists for religious reasons -- is now due this Thursday.
But, at the risk of actually applauding that dirty word "process," I have to admit that something good has happened on this bumpy, sometimes road-blocked route. Something called education. Even human understanding. Continue
Earlier reports on this topic are here.
Depositions Indicate Bush Administration Exerted Political Influence on FDA During Plan B Review Process
Center for Reproductive Rights Requests White House Subpoena
Center for Reproductive Rights website, August 3, 2006
August 3, 2006— Depositions released today by the Center for Reproductive Rights in its lawsuit against the Federal Drug Administration (FDA) indicate that the Bush Administration sought to unduly influence the agency during the Plan B application review process. One senior FDA scientist, Dr. Florence Houn, testified in July that she was told by Dr. Janet Woodcock [pictured here], then acting deputy commissioner of the FDA, of the need to appease the "administration’s constituents" by rejecting over-the-counter (OTC) status for women of all ages and then approving it down the road with an age restriction. This testimony directly contradicts the testimony of Dr. Woodcock, who earlier testified that she was not aware of any political pressure. Click here to read the depositions on the Center's website.
Tell the FDA: Just do it!
Is the Food and Drug Administration (FDA) ready to end its three-year delay on making the "morning-after" pill available without a prescription?
Action Alert from NARAL Pro-Choice America, August 2, 2006
Just this week the FDA has sent mixed messages about the future of improved access to the morning-after pill. On Monday, July 31, the FDA announced that it will reconsider whether to allow the morning-after pill to be sold without a prescription. However, the following day the FDA’s acting commissioner refused to say when the agency would make a decision.
Now we need you to take the next step and help make sure that President Bush’s FDA is doing more than just political posturing. Take action to tell the FDA to stand by the science, stand up to anti-choice politics, and make a decision on Plan B. Click here to send a letter from the NARAL Pro-Choice America website.
Plan B Moves Closer to Over-The-Counter Status
Focus on the Family, August 9, 2006
With news that the FDA is finally about to make the emergency contraceptive available over-the-counter in drugstores, Focus on the Family is exhorting its followers to stop it by lobbying the FDA and the White House. "Your voice is needed to stop it in its tracks," said a recent posting. Focus is also repeating misinformation that Plan B can "cause an early abortion." Click here.
FDA Chief Calls For Meeting With Barr Subsidiary
Says Age Restriction In Nonprescription Plan B Application Should Be Raised To 18
Medical News Today, August 3, 2006
FDA and Barr Laboratories have agreed to meet to discuss the company's application for nonprescription sales of its emergency contraceptive Plan B, FDA announced in a statement Monday, adding that it hoped remaining concerns regarding the application "can be wrapped up in a matter of weeks." We selected this report because it contains numerous links to coverage of these developments. Continue
In The Courts | FDA Scientist Was Told Nonprescription Plan B Application Would be Rejected 'To Appease the Administration's Constituents,' Deposition Says
KaiserNetwork.org, Daily Women's Health Policy News, August 04, 2006
FDA Deputy Commissioner for Operations Janet Woodcock in January 2004 said it was necessary for the agency to reject Barr Laboratories application for nonprescription sales of its emergency contraceptive Plan B in order "to appease the [Bush] administration's constituents," agency scientist Florence Houn testified in a deposition, which was released Thursday by the Center for Reproductive Rights, Reuters reports. Continue
The debate about Plan B
Amber Williams, The Tribune (Northern Colorado) February 10, 2007
DENVER -- A proposed bill in the Colorado Legislature tries to balance doctors' beliefs with hospital requirements when distributing information on emergency contraceptives. But local Christians say the legislation, which is a step in the right direction, still shouldn't require hospitals to promote Plan B.
Last year, Gov. Bill Owens vetoed a bill requiring physicians to tell patients about the availability of emergency contraceptives. This year's bill, sponsored by Sen. Betty Boyd, D-Lakewood, would require hospitals to adopt protocols to inform survivors of a sexual assault of the availability of Plan B. The bill exempts individuals who have moral or religious objections but not the institution itself, a point of contention among the opposition. Continue.
Plan B Compromise Might Be Closer
Church Is Studying Draft Contraception Bill Proposed By Lawmakers
By Hilary Waldman, The Courant (Harford, Connecticut), March 31, 2007
Women's advocates and the Catholic Church are trying to hammer out a compromise that would allow rape victims treated at Catholic hospitals to get a timely dose of emergency birth control pills in a way that does not violate the church's abortion ban.
Lawmakers and church representatives involved in the talks refused to discuss the negotiations, but details of the proposal are outlined in a draft bill obtained by The Courant Friday. Continue.
Hospitals Still Reluctant To Offer Plan B Pill
By Hilary Waldman, The Courant (Hartford, Connecticut), January 19, 2007
Even as the Plan B emergency birth control pill was heading toward more widespread availability at pharmacy counters, 40 percent of rape victims who sought care at Connecticut hospitals in the first half of 2006 were not offered the medication or were sent home without the full dose of the drug needed to prevent pregnancy, rape counselors say.
The continuing reluctance of hospitals - both Catholic and secular - to dispense the pills has prompted women's advocates to once again push the legislature to pass a law requiring all hospitals to provide the pill as a routine part of rape examinations.
Last year, a similar measure died in the final days of the legislative session amid strong opposition from the Catholic Church.
But rape counselors say that the problem is not limited to Catholic hospitals. Continue.
Woman protests Wal-Mart refusal to sell Plan B pills
AP, Cincinnati Post, January 16, 2007
COLUMBUS - A woman has complained to the governor and an abortion rights group about Wal-Mart workers who wouldn't give her morning-after contraceptive pills that don't require a prescription.
Tashina Byrd, 23, of Springfield, said the pharmacist "shook his head and laughed" when a pharmacy attendant asked this month about giving the woman and her boyfriend Plan B. The hormone pills can help prevent pregnancy if taken within 72 hours of unprotected sex.
The attendant told Byrd and her boyfriend, Brian O'Neill, 37, of Columbus, that the store stocked Plan B but nobody would give it to them, the couple told the Columbus Dispatch for a story Monday. Continue
Emergency Contraception: No Help if Women Still Can't Get It
Although Plan B, the 'morning after pill,' became available without prescription in November, women still face high costs, age restrictions, and limited availability in some places.
By Jeanine Plant, Women's eNews and Alternet, December 5, 2006.
Barr Laboratories began shipping Plan B to pharmacies nationwide on Nov. 6 on the non-prescription basis recently approved by the federal Food and Drug Administration.
That puts the pill within much easier reach.
But while access is now enhanced to the time-sensitive drug, barriers -- including some prices nearing $45 -- remain.
Because of its new non-prescription status, Carol Cox, a spokeswoman for Barr Labs, told Women's eNews that the distributor does not expect insurance companies to provide coverage for it and that Medicaid does not cover Plan B in all states.Continue
Support Access to Emergency Contraceptives
Religious Action Center for Reform Judaism, July 21, 2006
On April 21, 2003 product manufacturers Women’s Capital Corporation, controlled by Barr Pharmaceuticals, submitted a supplemental new drug application to switch “Plan B,” a concentrated dosage of birth control pills, from prescription-only to over-the-counter status for women of all ages....
Demand from Dr. Andrew von Eschenbach, acting director of the FDA, that there be no further delays in approval of emergency contraceptives for over-the-counter status. Speak out for women’s health by signing the National Council of Jewish Women petition: Click here.
Advocates Again Look to States to Promote Eased Access to Emergency Contraception
By Chinue Turner Richardson, Guttmacher Policy Review, Spring 2006
This article examines possible ways that states could enable physicians and pharmacists to work together to provide Plan B to women in a timely way. Included is a chart of what each state's laws permits. Click for the article (in PDF format).
OB-GYNs Urge Women to Get Advance Plan B Prescriptions
Ms. Magazine Feminist Newswire, May 9, 2006
Women should get a prescription for emergency contraception (EC) now, in case they need it later, advises the new "Ask Me" campaign by the American College of Obstetricians and Gynecologists. The campaign, launched Monday, seeks to bypass the FDA, which has not yet approved Plan B, a brand of emergency contraception, for over-the-counter sales despite the recommendations of its own scientists. Continue
OB/GYN group faults FDA on blocking OTC Plan B
By Rita Rubin, USA TODAY, May 8, 2006
WASHINGTON — The American College of Obstetricians and Gynecologists on Monday condemned the Food and Drug Administration for blocking over-the-counter sales of emergency contraception.
Group leaders held a press conference to announce a new campaign to stimulate discussion between OB/GYNs and patients about emergency contraception. At their annual meeting this week, members are handing out bright red buttons that say "Ask me."
The organization long has urged members to write emergency contraception prescriptions for all sexually active patients. Continue
This topic continues. Please click here.
Wal-Mart to carry Plan B contraception
Retailer's pharmacies currently only carry the product in 2 states -- Illinois and Massachusetts -- as mandated by law
CNN Money, March 3, 2006
"In a major turnaround, Wal-Mart will begin stocking Plan B contraceptives -- commonly referred to as the 'morning-after pill' -- at all of its pharmacies, the company said Friday.
"'We expected more states to require us to sell emergency contraceptives in the months ahead,' said Ron Chumiuk, vice president of Pharmacy for Wal-Mart, in a statement." Click here for the report.
Wal-Mart Bows to Public Pressure, Pledges to Stock the 'Morning-After' Pill
NARAL Pro-Choice America supporters sent 31,176 petitions urging retail giant to end discriminatory policy; organization criticizes decision to allow pharmacist refusals
NARAL Pro-Choice America News Release, March 3, 2006
"Washington, DC – Today Nancy Keenan, president of NARAL Pro-Choice America, called Wal-Mart's decision to end its policy against stocking the "morning-after" pill a step forward for American women's health and reproductive freedom. However, the retailer also said it would allow pharmacists to refuse to fill these prescriptions if they personally oppose birth control." Continue reading..
Wal-Mart bows to pressure, to stock abortion-causing drug
Tom Strode, Baptist Press, March 6, 2006
Baptist Press quotes an angry news release from Douglas Scott, president of Life Decisions International, reacting to Wal-Mart's decision to stock Plan B, the "morning-after" contraceptive. He said Wal-Mart’s executives had chosen to 'turn their backs on American families. It is up to the pro-family movement to let Wal-Mart know that the decision is not in its best interest from either a moral or business perspective." He added: "No company that chooses to sell such a controversial and deadly substance should be given a free ride."Click here to read more.
Hub women file complaint against Wal-Mart
Group also sues over failure to sell morning-after pill
By Bruce Mohl, The Boston Globe, February 2, 2006
Three Boston-area women yesterday sued Wal-Mart for failing to stock and dispense emergency contraceptive pills. They also filed a complaint with the state board that regulates pharmacies. Click here to read the report.
Joint Statement in Support of Lawsuit Demanding Access to Emergency Contraception at Wal-Mart
Letter issued by NARAL Pro-Choice America, Planned Parenthood Federation of America, the National Organization for Women, the National Council of Women's Organizations, and WakeUpWalMart.com, February 3, 2006
Washington, DC - At the same time Wal-Mart faces the largest gender discrimination class action lawsuit in U.S. history, affecting 1.6 million women, three Massachusetts women are now suing Wal-Mart over its failure to provide access to emergency contraceptive pills.
Wal-Mart's decision not to stock or sell emergency contraception - also known as Plan B® or the "morning-after pill" - unnecessarily denies women everywhere their right to access a legally-approved drug. The lawsuit charges that Wal-Mart is violating a Massachusetts policy requiring pharmacies in the state to dispense all "commonly prescribed medicines." Continue.
Public petition calling on Walmart to stock Plan B
NARAL Pro-Choice is collecting signatures on a petition calling on Walmart to change its policy against stocking Plan B. Click here for the petition..
Target at Center of Battle Over Plan B
By Allison Stevens, Women's eNews, January 15, 2005
Planned Parenthood and Target are scuffling over a woman's charge that a pharmacist refused to fill her emergency-contraception prescription. Click here for the report.
Planned Parenthood protests Target's Plan B policy
Star Tribune, November 11, 2005
"MINNEAPOLIS - Target Corp. is defending its policy on filling prescriptions for emergency contraception after the Planned Parenthood Federation of America accused the retailer of disrespecting customers' reproductive rights.
"Target allows pharmacists to choose not to fill requests for emergency contraception, also known as Plan B, if it is against their religious beliefs." Click here to read the report.
Former FDA chief: agency intended to allow over-the-counter sales of emergency contraceptive
Andrew Bridges, San Diego Union-Tribune, June 13, 2006
The Food and Drug Administration had intended to allow over-the-counter sales of Plan B last year but delayed the move while determining how to limit those sales to women 17 and older – a process that should have wrapped up by now, the agency's former chief testified.
Former FDA commissioner Lester Crawford, in a sworn statement, said he had reserved the right to decide whether to loosen the sales restrictions on the prescription-only emergency contraceptive pills. His account of that unusual and perhaps unprecedented move, given in a deposition over a lawsuit against the FDA, confirmed earlier testimony given by two senior agency officials who said he'd shut them out of the decision-making process. Continued
Crawford Expected Decision On Plan B Application Between 6 To 9 Months, He Says
Medical News Today, June 16, 2006
Former FDA Commissioner Lester Crawford last month in a deposition said that even though he delayed a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, he expected for the application to be approved or denied within six to nine months, the AP/Long Island Newsday reports. The Center for Reproductive Rights on Monday released a transcript of Crawford's May 24 deposition (Bridges, AP/Long Island Newsday, 6/13). Continue
Depositions of Former FDA Commissioner Crawford, Current Commissioner McClellan
The Center for Reproductive Rights, which is suing the Bush administration over its limits on Plan B's availability, has posted these and other documents from the case. Click here.
FDA chief's secret 'Plan B' meeting
By Kathleen Kerr, Newsday, May 12, 2006
An attorney for a women's rights group told a Brooklyn federal magistrate yesterday that while a controversial emergency contraceptive was pending before the Food and Drug Administration, it was the topic of discussion by a White House official and the then-FDA commissioner. Continue
Summary: Former FDA commissioner a no-show at deposition in lawsuit for Plan B approval
Former Commissioner Lester Crawford under criminal investigation
by JewsOnFirst.org, May 11, 2006
In late April 2006, there was a startling new development in a lawsuit to force the government to permit over-the-counter sale of the emergency contraceptive, Plan B. Former FDA Commissioner Lester Crawford did not show up for a scheduled deposition and his attorney said that he was under criminal investigation. She said he might have to assert his Fifth Amendment right not to incriminate himself at the rescheduled deposition on May 24th.
Crawford abruptly resigned from the FDA in September 2005 after three months at the post without an explanation. According to a University of Pittsburgh law school website, the investigation concerns financial wrongdoing and making false statements to Congress. Under Crawford, the FDA decided to restrict sales of Plan B. A New York-based public interest group, the Center for Reproductive Rights, filed the lawsuit. Another former FDA Commissioner, Mark McClellan, will testify in the case next month.
The FDA's politically tainted process is noted in a May 7th cover story in the New York Times Sunday Magazine (see below) about the religious right's thus far under-the-radar effort to curtail access to contraceptives.
In The Courts | Former FDA Commissioner To Testify in Plan B Lawsuit
KaiserNetwork.org Daily Reports, May 09, 2006
Former FDA commissioner Mark McClellan on June 13 is scheduled to testify in a lawsuit attempting to force the government to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B, the Long Island Newsday reports (Kerr, Long Island Newsday, 5/6). Continue
No show for deposition
Ex-FDA commissioner fails to testify about Plan B contraceptive
By Kathleen Kerr, Newsday, April 29, 2006
Former Food and Drug Administration Commissioner Lester Crawford failed to show up Friday for a court-ordered deposition in Washington, D.C., where he was scheduled to testify about the agency's refusal to approve over-the-counter sales of an emergency contraceptive. Continue
Former FDA chief under criminal investigation
Bernard Hibbitts, the Jurist, April 29, 2006
Lester Crawford, the embattled former head of the US Food and Drug Administration who stepped down in September 2005 after only three months in office in the midst of a furor over the agency's refusal to authorize over-the-counter distribution of Plan B emergency contraceptives, is under criminal investigation by a grand jury for alleged financial wrongdong and making false statements to Congress. Continue
By Russell Shorto, New York Times Magazine, May 7, 2006
This important report provides a detailed account of how, as it has gathered force, the religious right has been quietly moving against contraception -- in many cases with the explicit goal of limiting sex to procreation within marriage. At the moment, the fight appears focused on the emergency contraceptive, Plan B. But, according to the article, some "pro-life" activists are also taking aim at condoms, IUDs and oral contraceptives. Click here for the report
Wisconsin Attorney General asks to join lawsuit against FDA for Plan B pill
By Judith Davidoff, The Capital (Madison, Wisconsin), March 15, 2006
"Attorney General Peg Lautenschlager announced this morning that she has asked to piggyback onto a New York lawsuit filed by the Center for Reproductive Rights against the Food and Drug Administration for delaying approval of over-the-counter sales of Plan B, the so-called 'morning-after pill.'" Click here to read the report.
FDA must testify about Plan B lag
By Kathleen Kerr, Newsday, February 28, 2006
"Senior Food and Drug Administration officials must testify about the federal agency's failure to decide whether a controversial emergency contraceptive pill may be sold without a prescription, a federal judge in Brooklyn ruled late Friday." Click here to read the report.
Contraceptive suit still alive
Brooklyn judge refuses to dismiss a lawsuit looking to force the government to allow over-the-counter sales of the morning-after pill
BY Kathleen Kerr, Newsday.com, December 23, 2005
Saying "This has all the earmarks of an administrative agency filibuster," US District Court Judge Edward Korman, refused the Bush administration's motion to dismiss an action brought against the FDA by the Center for Reproductive Rights. Click here to read the report.
The FDA's politicized process to deny Plan B sales
Government investigation finds that FDA decision to deny over-the-counter sales of "morning after" Plan B contraceptive was unusual
The Government Accountability Office, an arm of the US Congress, released a report on November 14th concluding that the Bush Administration's Food and Drug Administration deviated from its own process to delay and finally deny the application to sell Plan B over-the-counter rather than by perscription. The GAO report (a PDF document, which you can read by clicking here, or, in summary, by clicking here), states:
The Plan B decision was not typical of the other 67 proposed prescription-to-OTC switch decisions made by FDA from 1994 through 2004. The Plan B OTC switch application was the only one during this period that was not approved after the advisory committees recommended approval. The Plan B action letter was the only one signed by someone other than the officials who would normally sign the letter. Further, there are no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B new drug application.
Pointed Report Issued On Plan B
By Jeffrey Young, The Hill, November 15, 2005
The Washington paper, The Hill, provides the basic facts of the FDA's long delay and final rejection of the application to permit over-the-counter sale of the contraceptive Plan B. The paper predicts that "the strongly worded Government Accountability Office (GAO) report will provide the Democrats who requested it with support for their charges that high-ranking administration officials interfered with the inner workings of the Food and Drug Administration (FDA)." Click here to read the report
Report Details F.D.A. Rejection of Next-Day Pill
By Gardiner Harris, New York Times, November 15, 2005
"WASHINGTON, Nov. 14 - Top federal drug officials decided to reject an application to allow over-the-counter sales of the morning-after pill months before a government scientific review of the application was completed, according to accounts given to Congressional investigators." Click here to read the report.
Former FDA Official Speaks On Plan B
Women's Health Expert Says Pill Must More Available
KCCI Television (Des Moines, Iowa), January 6, 2006
The former head of the U.S. Food and Drug Administration's Office of Women's Health is traveling the country campaigning for increased availability of the emergency contraceptive Plan B. Click here to read the report.
Strange Behavior at the F.D.A.
New York Times Editorial, November 15, 2005
Commenting on the FDA's handling of the Plan B application, the paper says: "It seems pretty clear that those running the agency were looking desperately for a reason - any reason - to prevent easy access to a contraceptive that is a red flag to the administration's conservative base. In doing so, they tarnished the reputation of an agency whose decisions are supposed to be based on science." Click here to read the editorial.
Heartless demise of Plan B
Toledo Blade Editorial, November 26, 2005
"The U.S. Food and Drug Administration needs a name for the outrageous regulatory mindset used to decide whether Plan B, the emergency contraceptive drug, could be sold without a prescription. In our humble opinion, FDA should call it the Queen of Hearts Rule. You know, from Alice in Wonderland, where the Queen declared, 'Sentence first - verdict afterward.'" Click here to read the editorial.
Plan B politics
Editorial, Boston Globe, November 20, 2005
"IN MAY 2004, the Bush administration had a chance to reduce the frequency of unplanned pregnancies and abortions by letting the Food and Drug Administration approve over-the-counter sales of Plan B, an emergency contraceptive. The proposal had the full support of the FDA's staff and outside scientific advisers, but it was blocked by an administration loath to rile conservative supporters who consider contraception only slightly less deplorable than abortion." Click here to read the editorial.
Concerned Women for America Leader Lauds FDA's Handling of Plan B Drug Review Process
By Mary Rettig, Agape Press, November 22, 2005
Concerned Women for America, a religious right organization, gave a number of reasons for celebrating the widely decried FDA decision not to permit non-prescription sales of Plan B, the "morning-after" contraceptive. Among those reasons: "making it easily available can lead to life-threatening complications, such as by encouraging risky sexual behavior." Click here to read the article.