Stonewalling Plan B

By Will Doig, Nerve.com. Posted November 18, 2005.

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?

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