Back in March 2009, President Obama issued a memorandum on scientific integrity to the heads of executive branch agencies and departments. It announced that “[s]cience and the scientific process must inform and guide decisions of [his] Administration on a wide range of issues.” And in a statement to the press, Obama insisted that “Our government has forced what I believe is a false choice between sound science and moral values.” Previous administrations (and one in particular — nudge nudge, wink wink … Know what I mean?) had let politics interfere with what should have been purely science-driven decisions by expert agencies. But that just wasn’t going to happen in the Obama administration.
I guess Kathleen Sebelius didn’t get the memo.
Yesterday, HHS Secretary Sebelius publicly overruled a decision by the Food and Drug Administration to make the Plan B emergency contraceptive available to girls under age 18 without a prescription. According to The New York Times, “Dr. Margaret Hamburg, the F.D.A.’s commissioner, issued a lengthy statement saying it was safe to sell Plan B over the counter, while Ms. Sebelius countered that the drug’s manufacturer had failed to study whether girls as young as 11 years old could safely use Plan B.” Commissioner Hamburg’s public letter on the decision explains that:
“Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs. [FDA’s Center for Drug Evaluation and Research] experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.”
I don’t have access to the scientific research that the FDA considered in making its decision, so I can’t comment on the wisdom of either choice. And no one should be so naïve to think that potentially controversial decisions by scientific agencies, including the FDA, have not been subject to political pressures for as long as agencies have been making such decisions. After all, back in 2003, an FDA advisory panel recommended changing Plan B’s status from prescription only to over-the-counter. And it was widely believed that the decision was being held up by the White House, which only relented three years later when faced with Senate opposition to the administration’s new FDA Commissioner nominee. Only then, in 2006, did the FDA finally allow OTC sales to women 18 and older.
What I find so striking is that the Obama administration would be so brazen about it after taking such a holier than thou attitude on scientific integrity. After all, this is believed to be the first time that an HHS Secretary has publicly overruled a decision of the FDA, which is part of that department. The administration clearly wanted us to know that it was overruling the FDA.
The entire affair reminds me of an episode from season three of the television show “The West Wing.” For those who are unfamiliar with it, that program was a weekly serial that dramatized events in the day-to-day lives of White House staffers for the fictional President Josiah “Jed” Bartlet — an attractive, thoughtful, passionate, articulate, liberal former college professor cum politician. Sound familiar?
By season three, President Bartlet was preparing for what was expected to be a tough re-election campaign when the White House staff was informed that the FDA was about to announce its approval of the controversial RU-486 — the so-called “abortion pill.” When Deputy Chief of Staff Josh Lyman suggests asking the FDA to postpone the approval, President Bartlet and the rest of the White House staff are indignant. “We could never interfere with an FDA decision,” they say, or words to that effect. “It’s an independent agency.” I recall screaming at my TV: No! Damn it! FDA is part of HHS. (Such is the life of a policy wonk.)
Oh, those were the days. When thoughtful liberal Democrats insisted that politicizing such an important decision just couldn’t be done — even behind closed doors, and even in the name of securing a much needed campaign advantage. Well, that was then, and this is now.
So, let’s hear it boys and girls: Can a White House devoted to scientific integrity and its political henchmen over-ride a decision by the Food and Drug Administration?
We They Can!