Plan B and Emergency Contraception

New England Journal of Medicine

Science has its say on Plan B

FDA Approves Over-the-Counter Access for Plan B

Plan B access? What Plan B access?

New England Journal of Medicine

Volume 347:846-849

September 12, 2002

Number 11:
On February 14, 2001, more than 70 organizations, including the American Public Health Association, filed a Citizen's Petition with the Food and Drug Administration (FDA), requesting that emergency hormonal contraception be made available without a prescription. The agency has still not acted on the petition. In the past 30 years, over 700 products have been switched from prescription to over-the-counter status. Recent examples include tioconazole, cromolyn sodium, bentoquatam, triclosan, and nicotine polacrilex.1

Science has its say on Plan B
Note: This opinion piece appeared in the March 17, 2006 Denver Post
By Jim Spencer
Denver Post Columnist
DenverPost.com

If the debate over Plan B emergency contraception had anything to do with science, said Susan Wood, there would be no debate.

"Based on public health and scientific evidence," said the former women's health director of the U.S. Food and Drug Administration, Plan B should be "available over the counter for everyone of child-bearing age."

Wood spoke at a Colorado state Senate hearing Wednesday to make that point. Plan B, she said, "is safer than aspirin."

Wood's testimony echoed a statement by a doctor from the Colorado Gynecology and Obstetric Society. The doctor's statement came at another statehouse hearing. Both hearings were for a law that lets pharmacists prescribe emergency contraception to women.

The American Medical Association and the Colorado Medical Society support making Plan B easily available. Pharmacists are ready to do the job, if the drug can't be sold over the counter. Still, Colorado's Plan B hearings became a forum where politics and religion posed as science.

Wood knows all about that. She quit the FDA because of it. Her legislative testimony Wednesday was her first. She came to Colorado to lecture at the University of Colorado Health Sciences Center. She's a scientist, not a politician.

That was why she decided to speak at the Senate hearing. As a scientist, Wood saw the studies that show Plan B is safe and effective in preventing the unwanted pregnancies that often lead to abortions.

She saw the studies that show the availability of emergency contraception does not cause young women to stop using regular birth control or engage in more unprotected sex. She saw the FDA's scientific advisory panel vote 23-4 to make Plan B available over the counter to everyone of child-bearing age. She saw the same panel vote 27-0 to endorse the safety of emergency contraception.

Then, Wood watched quackery.

She watched one Republican presidential appointee at the FDA refuse to accept the science of his own staff and advisers. When the makers of Plan B came back with a proposal to sell the drug over the counter to women 17 and older, Wood saw a second Republican presidential appointee indefinitely block Plan B by asking for comments that had nothing to do with public health and everything to do with bowing to charlatans who wrongly claim Plan B causes abortions.

So Wood left her job as an assistant commissioner of the FDA. She ended a 15-year government career advocating for women's health in Republican, as well as Democratic, administrations. "I think the agency lost its independence and put the credibility and ability of the FDA at risk," Wood told me. "I couldn't ignore that what they did was not in the best interest of women's health."

Plan B doesn't cause abortions, said Wood, who has a Ph.D. in biology. The drug will not end existing pregnancies. It works like regular birth control pills or intrauterine devices, delaying ovulation or fertilization. The charge that Plan B chemically changes the uterus and keeps some fertilized eggs from attaching to the uterine wall is speculative and no different from what an IUD might do, Wood said. "We don't have a test to see if a free-floating fertilized egg is in a
woman's system. But half of fertilized eggs (in an unaltered uterus) never stick anyway."

FDA advisory panel members who opposed Plan B also opposed all forms of artificial birth control, she added. That is their individual right. But it is not the right of a vocal minority to distort science or dictate public policy. "The vast majority of people," said Wood, "are  comfortable with contraception."

State legislators should remember that. So should Gov. Bill Owens. He hasn't taken a stand on pharmacists prescribing Plan B. But he vetoed a law last year that would have made hospitals tell rape victims about it. Owens vetoed the law after the Catholic Church claimed it violated
their hospitals' religious freedom.

With doctors and pharmacists on board, no such easy out exists this time. What's left is science. And as Susan Wood reminded everyone this week, the scientific community has spoken.

Jim Spencer's column appears Monday, Wednesday and Friday. He can be reached at 303-820-1771 or jspencer@denverpost.com.

FDA News
FOR IMMEDIATE RELEASE
P06-118 August 24, 2006
Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older Prescription Remains Required for Those 17 and Under

The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older. Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills--only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under.

Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. In the CARE (Convenient Access, Responsible Education) program Duramed commits to:

• Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;

• Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made
  available to younger women without a prescription;

• Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and

• Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Today's action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application to switch Plan B to OTC use. Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package.

The agency remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans.

For more information on Plan B and today's action, please see: http://www.fda.gov/cder/drug/infopage/planB/default.htm.

Plan B access? What Plan B access?

Salon.com

September 25, 2006

Thanks to numerous Broadsheet readers for tipping us off to a sad and terrifying account of an Ohio woman's quest for emergency contraception. BB of Den of the Biting Beaver spent the whole of last weekend unsuccessfully searching for Plan B after a condom broke during sex. She was unworried at first -- after all, we all loudly celebrated the Food and Drug Administration's approval of over-the-counter access to Plan B earlier this year. But when she called her local pharmacy, she was told that it wouldn't carry Plan B until the start of next year.

BB called her doctor, who instructed her to visit the emergency room; when she called the E.R., a nurse warned her that she would have to "meet the doctor's criteria before he'll dispense it." Then the nurse tactlessly inquired whether she was raped and if she was married. As an
unmarried woman who had engaged in consensual sex, BB was unlikely to beat the hospital's narrow criteria and senseless red tape: "The problem is that we have 4 doctors here right now but only one of them ever writes [emergency contraception] prescriptions," the nurse told
her. "But see, the thing is that he'll interview you and see if you meet his criteria ... there's really no harm in trying."

Discouraged, BB called her local urgent care center. As the nurse there told her, "We don't prescribe the abortion pill here." (A reminder for anyone who may have missed the memo: Plan B is not abortion! For a handy disambiguation of the two processes, go here.) The nearby Planned Parenthood offices were closed. BB says she called every hospital within reasonable driving distance and learned that the local facilities either wouldn't prescribe the pill or required a lengthy screening process like the first hospital she called. One nurse even qualified a doctor's screening criteria for dispensing E.C. as "kind of old-fashioned." Even if she'd tried to persuade a reluctant hospital doc, the copay for seeing a physician was unaffordable, especially
considering her visit would likely be futile. By way of a tip from a fellow blogger on Monday, BB finally found a clinic -- more than an hour's drive away -- that would provide her with Plan B. Already a mother of three, she has no idea at this point whether she managed to prevent a pregnancy, since the sooner Plan B is taken, the more effective it is.

First and foremost, BB's troubles call attention to what should be considered criminal institutional barriers to legal emergency contraception. But almost as startling is the way that even staunch supporters of over-the-counter Plan B access are edged into qualifying a woman's right to take the pill. The governing rhetoric is that rape victims are most deserving, followed by married women; single women aren't deserving at all. "I found that the more hospitals and clinics and doctors I called the more ashamed I became," BB wrote. "Yep, you heard right. I was feeling ashamed at being such an unworthy dirty whore."

-- Tracy Clark-Flory