The Saga Continues: Plan Z for Plan B

Democratic Senators Hillary Rodham Clinton (NY) and Patty Murray (WA) are continuing to block the confirmation of the Food and Drug Administration (FDA) Commissioner, Dr. Andrew von Eschenbach.

It’s government in action, because under Senate rules, any senator may place a hold on a floor vote to approve a nominee.

The Senators don’t have a problem with Dr. Eschenbach himself, they say. In fact, they praise his credentials; but, they protest the FDA’s continual delays of Plan B, commonly known as the morning after pill.

What is the morning after pill?

The morning after pill or, Plan B, is emergency contraception that works to prevent pregnancy when taken up to 72 hours after unprotected sex. Medical professionals do not consider Plan B an abortion pill, because unlike RU-486 or Mifeprex, it prevents pregnancy from starting but does not terminate a pregnancy in progress.

Plan B consists of two high doses of levonorgestrel, a hormone frequently used in birth control pills. Like the pill, Plan B interferes with ovulation or prevents the implantation of a fertilized egg.

Emergency contraception is currently available by prescription only. In order to sell it over-the-counter, Barr Pharmaceuticals, which makes the product, conducted a study involving 585 women to verify the drug’s safety and usability.

To determine if a drug can be sold without a prescription, federal regulators ask three crucial questions: can patients diagnose the problem themselves? Can they be trusted to treat the problem effectively? Can they understand the drug’s label without a physician?

Christian physicians consider other concerns

The Christian Medical Association (CMA), a 17,000-member organization, has pleaded with the FDA to oppose the over-the-counter sale of Plan B.

The CMA argues considerations that most young women seek medical counsel in order to obtain contraception. If contraception is available over the counter, they argue, young women will bypass the system that provides sexual counseling and can prevent, diagnose, and treat sexually transmitted diseases.

Other medical experts disagree with the CMA. In December 2003, an FDA expert advisory panel voted 27 to 0 that the drug could be safely sold over-the-counter. The group also voted 23 to 4 that Plan B should be sold without a prescription.

The history

In May 2004, the director of the FDA’s Center for Drug Evaluation and Research, Steven K. Galson, signed a "not approvable" letter for Plan B, going against the advisory panel’s recommendations. Such a move is almost unheard of since the FDA typically follows the advice of its staff and committees.

Galson argued that Barr Pharmaceuticals failed to prove that girls age 16 and younger could use Plan B without a physician’s guidance. The company’s label-comprehension study included just 29 girls age 17 and younger and no girls age 14 and younger out of the 585 women tested.

The FDA decision gave Barr Pharmaceuticals two choices: redo the study and include more women age 16 and younger, or reapply to sell the drug only to women age 16 and older.

In July 2004, Barr reapplied to the FDA to sell the drug over-the-counter with an age limit, requiring younger girls to get a prescription.

Over a year later, on August 26, 2005, the FDA deferred any decision on Plan B, claiming 60 days of public comment was needed. The FDA said it needed more time to gauge public reaction and decide how to monitor Plan B sales in order to make sure that girls aged 16 and younger don’t buy the emergency contraception without a prescription.

The politics

Senators Clinton and Murray have been outraged since 2005, when they made a deal with Michael O. Leavitt, secretary of Health and Human Services, in which they agreed to stop blocking the confirmation vote on Dr. Lestor M. Crawford, Bush’s then-nominee for FDA commissioner. In exchange, Leavitt would make sure that the FDA came to a decision on Plan B by September 1, 2005.

Crawford is not the commissioner, but Clinton and Murray say Leavitt did not live up to his end of the bargain. The FDA avoided a decision, claiming it needed more time. The delay caused Dr. Susan F. Wood, the director of the FDA office of women’s health, to resign in protest.

That’s why this time around, Clinton and Murray won’t allow Dr. Eschenbach to be confirmed until the FDA makes a clear decision one way or the other on the drug.

On August 8, 2006, the FDA and Barr Pharmaceuticals announced a plan to get Plan B on the shelves. But this time, Barr needs to reapply for over-the-counter sales limited to women older than 18. Clinton and Murray are weary of the statement since it still involves FDA approval.

What do you think?

Who should have over-the-counter access to emergency contraception? Is it better to keep the morning after pill behind the counter? What do you think of the Senators’ actions here? Still not sure? For more information on this issue, listen to our healthcare radio show.

Your input matters

Your representatives DO care what you think. Especially now -- 2006 is an election year and many representatives will be looking to reconnect with their constituents. Let your congressmen and women know what you think! Give your senators a piece of your mind! To find your reps, click here.

About WomenMatter

WomenMatter is a place to discuss life issues with other women. We don’t want to wedge women apart, but rather bring them together to dialogue. To participate in our blog, click here.

WomenMatter is the place where we can take one issue at a time, match what we do about it every day of our lives to the facts of the bigger system that we all live in and recognize that every idea for making it better has tradeoffs.

WomenMatter is dedicated to empowering women to participate in the political process. To do this we have invested in the most in-depth NONPARTISAN information, because we trust each woman to make up her own mind.

• We track nine issues every week and update this website several times a week.
• We launch after school GirlsMatter Clubs in middle and high schools to grow the next generation of politically aware women through a full curriculum and startup kit on girlsmatter.com.
• We do continuous research to make sure that we are meeting the needs of women across the country of all ages, races, incomes, preferences, and religions.

We offer all our services free of charge without memberships or subscriptions. To help us maintain this work - not just in election years but as a continuing part of women’s lives - please make a tax deductible donation, click here.

Posted on: 8/13/2006