Stonewalling Plan B

The Food and Drug Administration, for all its faults, has largely preserved a dispassionate scientific sobriety above the tides of public philosophy.

In fact, its earliest incarnation was a humorless little office called the Bureau of Chemistry, which was created by President Lincoln in 1862 and headed by an actual chemist. In later years, the FDA would regulate tea importation, penicillin and a polio vaccine with an impressively unsympathetic eye. In 1959, with almost Grinchian relish, they recalled the entire U.S. cranberry crop three weeks before Thanksgiving.

But more bothersome still is what it shows signs of becoming: an agency that allows the safety of our food and meds to fall victim to ideology. Such a concept was disturbing enough to drive Dr. Susan Wood out. The former director of the FDA's Office of Women's Health, Wood recognized, as did virtually every other member of the agency's staff, the safety and necessity of an emergency contraceptive called Plan B. Compared to other products the FDA had approved, Plan B was a no-brainer, safe and effective.

Crucially, it was time sensitive, requiring dosage as soon as possible after, say, condom breakage, to prevent unwanted pregnancy. For this reason, it would need to be available without prescription.

Yet today, Plan B sits not on a Rite Aid shelf, but in a bureaucratic holding pattern that will likely endure for years. After being recommended for approval at every level of its formal review, the pill mysteriously ended up in what is called a "rulemaking process" to determine whether the product can be given "dual status," which would make it available without prescription for adults but not for minors.

FDA staffers say this is simply a way to ensure that Plan B stays in purgatory (for a few more election cycles, one could imagine.) Wood took the strongest stance, resigning in protest on August 31.

What is the function of the FDA's Office of Women's Health?

It was created to focus on the inclusion of women in clinical trials. For example, right now there's a lot going on with coronary heart disease. The office would focus on questions of whether the medications are safe and effective for women. When I was there, we had a budget of around $4 million.

In the case of Plan B, the FDA decided to solicit public comment about whether it should be available without prescription. What's the value of getting input from a public with no medical expertise?

The FDA is proposing going into a rulemaking process, or the development of a regulation. When you develop a regulation, you begin by asking for public comment, asking people what sort of issues they think need to be addressed.

What's wrong with that?

Rulemaking is a long, multiyear process. I'll give you a good example of necessary rulemaking. When the FDA was given the authority by Congress to regulate mammography facilities, it required establishing standards for facilities throughout the country: who does the inspections, what level of training do the physicians need, what about the technicians who upkeep the machines, what about the standards of the machines themselves . . . it was big and complex and took several years to develop the rules and regulations to ensure that an FDA-certified mammography facility is in fact a good one.

In this case, it's an abuse of the system. We've had multiple products out there on dual status, and we've never felt the need to go through rulemaking on them before. But for some reason, this time we announce that instead of approving [Plan B], which is what the evidence says we should do, we're going through rulemaking. It sounds like just sixty days of public comment, but that's just the first one percent of how long this is going to take. It's a very big deal to pass a regulation. It's going to be years before we get through this.

Recently, we've witnessed what seems to be an ideological drift in women's health issues -- abstinence education, parental notification laws, etc. Is this part of that?

The common thread in those things you mention would be that there now seems to be a problem with contraception itself. Contraception seems to have become controversial. We assume that contraception is not controversial and here we are proven wrong. That said, I think it's only controversial for a very small group of people, but they're clearly wielding enormous influence.

The FDA is part of Health and Human Services, which is run by the executive branch of the federal government. The delay of Plan B is certainly in step with this executive's ideology, don't you think?

I agree, but historically, to a very large degree, the FDA has maintained its independence. Though it's part of the chain, it should be able to build a wall so that it gets input, but the decision-making is made inside the FDA. What appeared to happen in the emergency contraception decision was the professional staff was completely locked out and a decision was issued without the usual consultative decision-making. That's extraordinary.

If historically the FDA has been able to maintain that wall of independence, why does it seem to be coming down now?

Well, as to the change in the administration or who is able to influence this administration, I'll let other people speculate on that.

When it's reported that "the FDA made this decision," who exactly are they talking about? Who is "the FDA?"

In a normal process, this never would have reached the leadership of the agency. Somewhere in the middle, there's the authority to issue a decision on a product, and if the normal process had occurred, that's what would have happened. But something above the bureaucratic process -- something happened at the leadership level of the agency, or beyond, and the only thing that I'm at this point willing to say, and it's speculative but I feel pretty confident, is that the agency was not acting independently. The leadership of the FDA overruled every level of staff review in the agency. None of the decision-making process was followed in a normal way. And the fact that the current acting commissioner hasn't changed the direction shows that the agency is still not acting independently.

Who appoints the commissioner?

It's a presidential appointment.

And Lester Crawford, who was commissioner when the decision to start a rulemaking process for Plan B was made, has since resigned.

He resigned suddenly and unexpectedly, and there's lots of speculation as to why, but I have no inside scoop. They've since appointed a new acting commissioner. He was Bush Sr.'s prostate doctor.

He was appointed by the current President Bush?

Yes, and he hasn't changed direction at all.

The FDA is not involved in national security or anything like that. Why does it seem to be such a shadowy organization? Why isn't this process more transparent?

A lot of the stuff is confidential because pending decisions can affect the stock market and insider trading. So there's a lot of regulation that prevents the FDA from talking about where it is in the process.

Critics of emergency contraception say that it could encourage unprotected sex, thereby increasing the likelihood of STD transmission. Is it the FDA's place to consider hypotheticals like this?

Yes, to some degree, they have to balance risk-benefits. But there have been studies done that show emergency contraception does not change sexual behavior or regular contraceptive use. So not only is there a lack of evidence of a problem, there's evidence to show it doesn't cause a problem.

American Life League Director Julie Brown says Plan B contains a chemical that can contribute to heart problems and blood clots. Do you know what chemical she's referring to?

She's referring to progestin, and yes, if you're taking it as hormone-replacement therapy every day it comes with associated risks. But this is one-time use. The vote on safety was unanimous. And American Life League, I'd point out, is opposed to all forms of contraception. People need to understand that a lot of the people who are against emergency contraception have made the same arguments against regular birth-control pills.

The U.S. Bishops Pro-Life Secretariat has said that Plan B can also be used as an abortion pill, after conception, by impeding the movement of the new embryo through the fallopian tube. Medically speaking, is this considered abortion?

Medically speaking, it is not considered abortion. Progestin is the same natural hormone that a woman's body produces while she's breastfeeding to help prevent her from getting pregnant. If you're comfortable with breastfeeding, you're comfortable with emergency contraception.


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