FDA Nominee Defends Actions on Morning-After Pill

Andrew von Eschenbach

Sen. Hillary Clinton (D-NY), listens to Andrew von Eschenbach testify on Capitol Hill Tuesday. Win McNamee/Getty Images hide caption

itoggle caption Win McNamee/Getty Images

Andrew von Eschenbach, President Bush's nominee to head the Food and Drug Administration, finally got his chance to make his case before a Senate committee.

But his fate is now wrapped up in a fight over whether to approve over-the-counter access to the so-called morning-after birth-control pill — as well as broader questions about the intersection of science and politics.

Q&A: The Debate Over The Morning-After Pill

Plan B

Plan B's maker Barr is asking the FDA to allow the emergency contraceptive to be sold without a prescription. Jim Pathe/Star Ledger/Corbis hide caption

itoggle caption Jim Pathe/Star Ledger/Corbis

How It Works

Emergency contraception is available in several forms. The most effective, according to the Association of Reproductive Health Professionals, are those that contain a single female hormone, progestin. Two progestin-only pills are sold in the United States: Plan B and Ovrette. Only Plan B is specifically marketed for use as emergency contraception, but either can be used.

   

The active ingredient in Plan B and Ovrette, progestin, is one of the hormones commonly found in standard birth control pills. However, Plan B contains a higher dose of progestin than does a standard birth control pill.

   

Plan B comes in a two-dose package. One pill is taken 12 hours after the first. To get protection with Ovrette, 40 of the "minipills" must be taken to equal the dose of progestin found in Plan B. Whichever is chosen, the sooner you take the pills, the lower your odds of getting pregnant.

Plan B recommends that to obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of unprotected intercourse.

   

Another type of emergency contraception uses a combination of two female hormones: estrogen and progestin. Outside the United States, this combination is packaged for sale as emergency contraception.

   

In the United States, doctors must prescribe regular estrogen/progestin birth control pills (only certain kinds work for emergency use) and instruct teens and adults in how to take them.

   

Use of this type of emergency contraception reduces the odds of getting pregnant by 75 percent. As the ARHP Web site Not-2-Late.com explains, this doesn't mean that 25 percent of women using estrogen/progestin combinations will become pregnant.

   

"Rather, if 100 women had unprotected intercourse once during the second or third week of their cycle, about eight would become pregnant," according to the site.

   

Following treatment with an estrogen/progestin combination, only two women would become pregnant. In other words, a 75 percent reduction in the odds of becoming pregnant.

   

One of the controversies that surrounds this topic is the way these pills work inside the body.

   

Opponents of abortion rights say that the pills sometimes work to prevent the implantation of a fertilized egg into the uterus. They consider this action to be the same as an abortion. This raises the issue of when a pregnancy actually starts.

   

The U.S. government and leading medical societies define pregnancy as beginning at implantation, not fertilization. Other contraceptives also work by preventing implantation of fertilized eggs, blocking fertilization or inhibiting ovulation.

   

Emergency contraceptives are not to be confused with the so-called abortion pill, RU-486, sold under the brand name Mifeprex. Mifeprex can only be used after a pregnancy has been established. — Joe Neel

For three years, drugmaker Barr has asked to sell the emergency contraceptive Plan B without a prescription. And now the Food and Drug Administration says it's willing to consider a compromise.

FDA officials are considering an unusual split status for Plan B. Those 18 or older could buy the drug over the counter. Anyone younger than 18 would still need a prescription. Barr is requesting that the drug be sold to those older than 16.

Sens. Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) call the FDA's announcement "more smoke and mirrors." The senators earlier pledged to block any nomination of a new FDA chief until the agency made a decision — yes or no — on the status of Plan B.

Here, a look at the science and debate over Plan B:

Q: How does the drug work?

The drug consists of two high doses of the hormone progestin — the most common ingredient in regular birth control pills. If taken within 72 hours of unprotected sex, it reduces the odds of getting pregnant by 89 percent. The chances of getting pregnant are even lower if Plan B is taken sooner.(See sidebar for more on how the drug works, and how it differs from the abortion pill RU-486.)

Plan B is now available by prescription. Why do supporters want it sold over the counter?

Plan B is most effective if taken within the first three days after unprotected sex. Some women's health groups, such as the National Organization for Women and the Reproductive Health Technologies Project, argue that most unprotected intercourse happens on the weekend, when it's hard to reach a doctor to ask for a prescription. If Plan B were available without a prescription, say supporters, women could obtain and take the drug sooner, making it more effective.

What are the objections to making Plan B available over the counter?

The FDA originally said no to Barr Pharmaceuticals' request in 2004, citing in part concern over young teens using the drug without a doctor's supervision. Opponents of the drug also say that easier availability could encourage teens to have sex and might increase the spread of sexually transmitted diseases.

Some anti-abortion groups also debate how Plan B works. They say it could act to prevent implantation of a fertilized egg, thus making it, in their view, a drug that causes abortion rather than a contraceptive.

Supporters counter that making the product more widely available could greatly reduce the risk of unintended pregnancy and the need for abortion.

Aren't there ways around the last-minute rush to get a prescription?

Through collaborative agreements between individual physicians and pharmacists, women can get Plan B without a visit to a health care provider in nine states: Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington.

The Association of Reproductive Health Professionals' Web site Not-2-Late.com also lists brands of regular birth control that can be used as emergency contraception. ARHP, along with the American Medical Association, recommends that doctors write advance prescriptions for women so they'll have the drug when they need it.

What's the status of emergency contraception in other countries?

At least 41 countries sell emergency contraception without a prescription, according to Lisa Wynn of Princeton's Office of Population Research. Some countries do have age requirements, such as Great Britain, where emergency contraception is available without a prescription only for those 16 and older.

Other countries where emergency contraception is available without a prescription include Aruba, Australia, Belgium, Benin, Burkina Faso, Cameroon, Canada, China, Congo, Denmark, Estonia, Finland, France, French Polynesia, Gabon, Ghana, Greece, Guinea-Conakry, Iceland, Israel, Jamaica, Latvia, Luxembourg, Mali, Mauritania, Mauritius, New Zealand, Niger, Portugal, Senegal, Slovakia, South Africa, Sri Lanka, Switzerland, Togo and Tunisia.

What are the side effects and risks of Plan B?

Side effects are similar to those of regular birth control pills: nausea, vomiting, cramping, fatigue, headache, dizziness, breast tenderness and menstrual changes. The AHRP says "most women can safely use emergency contraceptive pills, even if they cannot use birth control pills as their regular method of birth control."

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