The Doctor Is In: It's a new morning at the FDA for the morning-after pill

I can't speak for all scientists, but I think most of us are hopeful that the new administration will usher in a new era in which health policy is dictated by scientific evidence instead of religious and political ideology. An indication of just how much of a switch that would be from the previous administration is found in the recent decision by a federal judge in New York ordering the FDA to allow 17 year olds access to the morning-after pill without a prescription.

Marketed as Plan B, the morning-after pill (actually, it involves taking two pills) is intended as an emergency form of birth control after unprotected sex or if another form such as a condom fails. The FDA approved the drug for over-the-counter sales in 2006, but limited it to women 18 and older. The recent court ruling describes how that decision was just the last in a long line of arbitrary policies and delay tactics regarding the drug shaped by political pressure from President Bush's conservative base -- and frequently made in the face of recommendations by the agency's own advisory panels. Religious conservatives oppose Plan B on the grounds it's an "abortive agent," but by any objective measure, that's a stretch. In most cases, the morning-after pill works by preventing the release of the egg by the ovary or the union of egg and sperm -- i.e., the same way all oral contraceptives works. Only if fertilization has already taken place can the pill also prevent the zygote from attaching to the womb and forming an embryo.

The new battlefront

The data is overwhelming: The morning-after pill is safe, with zero long-term side effects. Hundreds of my patients have used it effectively with no or only minimal (short-term nausea, abdominal discomfort) side effects. Many of my patients who ask for it were using condoms that failed. Few if any were using the morning-after pill as a replacement for birth control.

Now that 17 year olds have been cleared to buy the drug without a prescription, the battle will shift to whether younger teenagers will be allowed to do the same, as they are in other countries. It's encouraging that the court noted that the Obama administration seems prepared to let the scientific review process do its work. Still, opponents are already gearing up for a fight, instilling fear in parents about all the horrible things that will happen if 13- or 14-year-old girls get their hands on these pills.

First, I want to point out that children can buy pain relievers, cold medicines and even household cleaners with far more serious side effects and potential dangers than this drug. More to the point, widespread availability of the morning-after pill has the potential to prevent unplanned pregnancy and abortion -- both of which pose far greater risk and hardship to teen girls.

The fact is, every year 750,000 teens aged 15 to 19 become pregnant, according to the Alan Guttmacher Institute. With rare exception, most teenagers are not trying to get pregnant. They frequently present late for prenatal care, and face numerous psychosocial difficulties in either deciding to abort or carry a pregnancy to term.

When I was a resident at a public hospital in the Bronx, I saw a lot of teenagers and girls as young as 12 who were pregnant. The first prenatal care some some of them received was at full term. A few cases still stick out in my mind, including one 16-year-old girl who bled to death from a late-term ectopic pregnancy that ruptured in her fallopian tube.

The irony is that once a girl is pregnant, she's legally considered an "emancipated minor" -- which means she can make medical decisions of a much more serious nature without adult supervision. And yet we can't trust her to make a decision that will keep her from getting pregnant?

In my practice, I remind teens who are sexually active to call me immediately if their condom breaks or they have unprotected sex so I can write a prescription to be filled at a local pharmacy. However, the drug must generally be taken within 72 hours to be effective -- and is most effective when taken within 24 hours. So even the simple process of calling in a scrip can eat up valuable time. Also, some physicians might not be as flexible as I am. They may request that patients be seen in person to obtain a prescription, or require parental consent or refuse to provide a prescription altogether. Girls who have no primary physician need to know to go to an emergency room to obtain the pills.

Such barriers make no sense. At least the courts seem confident that the Obama Food and Drug Administration will undertake a thorough -- and objective -- analysis of the facts before it (hopefully) agrees.

Russell Turk, M.D., is an obstetrician and gynecologist in Fairfield County, CT.
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