Who Do We Blame for the Emergency Contraceptives-for-Kids Ruling?

Image: °Florian via Flickr (CC BY-SA 2.0)

The New York Times headline on Friday likely caused readers to perform a Maggie Smith-esque double take: “Judge Overturns Age Limit to Buy a Contraceptive.” That’s a weird way of saying it, so to limit exposure to the seven or eight print subscribers the Times still enjoys, the online headline was a little different: “Judge Strikes Down Age Limits on Morning-After Pill.” A little better, but still — what? How does a single federal judge in New York City make a decision like that for the entire nation?

The short answer is: because we told him to, because, really, we told the agency to in the first place. Don’t look at the judge – though the tone of his opinion makes him a little hard to love. Don’t look at the FDA, who initially approved this same action. It’s time we put blame where blame is due – on We the People and the Congress we’ve picked for ourselves.

The long answer lies securely locked away in the heart of the catacombs known as the “modern administrative state” — the nearly Orwellian phrase that describes the kind of behemoth centralized government we’ve discovered is our master. Here is an extremely simplified timeline:

• The FDA approved Plan B as an emergency contraceptive in the late 90s, but it was only available with a prescription.
• In 2003, reproductive rights advocates (among others) petitioned the FDA to make the drug available without a prescription.
• The FDA under Bush denied the petition and the petitioners sued the agency.
• A federal judge in New York ruled that the denial was “arbitrary and capricious” and ordered the FDA to reconsider it, but to do it right this time or it would go to its room. This order came right when Obama was taking office, and the judge was optimistic that the new administration would thoroughly and properly consider the petition.
• Obama appointed Kathleen Sebelius as his Secretary of Health and Human Services (under which the FDA is organized), who promptly placed the petition in a desk drawer for a rainy day, I guess.
• No one did anything with the petition for years.

Then in 2011, the makers of Plan B submitted a proposal for Plan B One Step that argued it was safe for use at any age and there was no special reason to require a prescription. The FDA reviewed the application – and promptly approved it. In a completely unexpected move, Secretary Sebelius sent a memorandum to the Commissioner of the FDA ordering her to deny the request. Sebelius cited her concerns about making the drug available to girls as young as 11 years old with no parent or doctor involvement. Specifically, she noted that the studies the FDA relied on did not test the effectiveness of the labeling at the lower end of the age spectrum. President Obama supported her decision publicly – it was an election year – and made a broader appeal by invoking his daughters.

Shortly thereafter, the FDA denied the original petition. Back to court we go, and guess who draws the case in the Eastern District of New York but our old friend, the judge from the original case!

Well, he was not amused. Judge Korman’s opinion upbraids the administration for allowing politics to trump science. He carefully and caustically attacks the government’s case, ridiculing the “excuse[s] offered by the minyan of attorneys representing” HHS. He refers several times to the constitutional right to contraceptives and bristles at the idea that a woman – or girl – might have any trouble getting her hands on Plan B at any time. He ordered the FDA to grant the original petition:

[T]he decision of the FDA denying the Citizen Petition is reversed, and the case is remanded to the FDA with the instruction to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions[.]

Back to the original question – where does a single court get this kind of power? Administrative agencies have considerable power. In this example, a small body of medical experts in Washington, D.C., decide which powerful chemicals are available, to whom, and where. These agencies make rules with the force of law and adjudicate cases that can impose millions in fines (and sometimes worse). Recognizing the potential for abuse, the law requires these agencies to follow certain procedures and subjects them to various other constraints. The Administrative Procedure Act is supposed to ensure that agencies are subject to the same procedural and democratic controls as the rest of the government.

Federal law allows allows a person injured by any agency action to sue that agency, and the court is required to “hold unlawful and set aside agency action, findings, and conclusions found to be… arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” This means that agency action has to have a clear basis in the evidence, and the agency must make decisions in a fair and transparent manner. Furthermore, the Food, Drug, and Cosmetic Act is the law that allows the FDA to exist, and it specifically requires that determinations be made on the basis of “safety.”

To simplify: Congress passed a law telling the FDA to regulate drugs for safety and not on general policy grounds, and gave the rest of us the right to sue if we thought we were injured by a wrongful FDA decision. We would be grateful for these protections if the Secretary of Transportation randomly ordered the highway department to seize our city parks to build a freeway. Even if we lost, at least we would have our day in court and the secretary would be required to explain himself publicly.

But do we really want some faceless bureaucrats with a string of medical degrees deciding whether our 11-year-old daughters should be able to pick up powerful contraceptive hormones “alongside bubble gum or batteries,” to use the president’s phrasing? Most drugs do not have the kind of moral and social implications that contraceptive hormones do, so we must be careful to place blame where it belongs. In this case, it was all of us who handed over this authority to the FDA, effectively telling them “handle this for us, and only consider scientific safety considerations.” Once that law was in place, what else should we expect them to do?

A constant source of security, we are told, is that the political branches retain final authority over these agencies. Cold comfort, that, with the pace of change in Washington. But the fact remains that the decision to license and approve drugs was not forced on us. It is the scheme we chose. As Christians, we believe that there is more to the human person than can be measured by lab reports and social science studies. The decisions we make as a political community are not subject to the god Science’s whims any more than they are to the whims of a cabinet secretary.

We should avoid trying to translate our values into the language of science, especially when it comes to human sexuality. Life makes no sense that way, and we sound like pseudo-scientific prudes when we take it too far. Sure, there are legitimate health and safety concerns with these drugs. But the real issue is that we don’t intend to surrender these kinds of decisions to the cold sterility of scientific calculation. If that’s what the law requires now, then it is time to change the law. But whose fault is that?