In a surprising turn-around Monday, the Food and Drug Administration (FDA) re-initiated discussions with Barr Pharmaceuticals about the company's Plan B birth-control, an emergency contraceptive. The move came one day before Senate confirmation hearings with acting FDA head Andrew von Eschenbach on his nomination to the permanent post heading the FDA.
Andrew von Eschenbach, on the brink of a Senate nomination to become the full time chief of the FDA, claims that the latest surprise decision to approve over-the-counter Plan-B one day before his Senate confirmation hearings is not politically motivated. In the committee hearings yesterday, Senator Tom Harkin (D. Iowa), said "We all know what's going on here. This is a disregard for science out of ideological concerns". To which von Eschenbach replied that his decision was based on a particular, non-ideological type of ideology: "not on a political ideology, but on a medical ideology."
In light of recent history and the fact that there are reportedly 100 whistle-blower cases currently active in the FDA alleging conflicts between ideology and science in the agency, we wonder about his assertion. A recent poll by the Union of Concerned Scientists, showed that 40% of 1000 FDA employees polled said they knew of cases where political appointees had interfered with agency decisions. Given this, Von Eschenbach's assertion borders on outlandish. Therefore, despite his "impeccable credentials", why, when grilled about the politics, did he not say something like this:
"Sir, Honorable Senator, I was a "political appointee". Bush and I are family friends from Texas. We're pals, in fact sometimes he affectionately calls me little nicknames like he does the others. Perhaps we pray together, but I'm not telling -- top secret. The point is, how could I be a "political appointee" and NOT understand the Imperative of Politics for an FDA chief? You've got the Pharmaceuticals, the left wing, the right wing, you've got religion, you've got deaths from drugs claiming to cure this and that, you've got scientists clamoring, citizens clamoring, and lobbyists swarming The Hill. I would be (in fact, I am now) juggling life and death decisions day in and day out and balancing those with the pharmaceutical industry, a virtual economic powerhouse. Silly Senators, of course, the FDA is willing to announce that Plan-B is slated for approval. Stop acting like you're surprised. Honorable Senators, if this weren't about politics, why would I be entertaining this barrage of questions from you, the politicians? Senators Murray and Clinton have said they won't appoint me with Plan B in limbo. I'm politically prudent. You're politically prudent. Senators, be real -- shall we revisit your campaign "promises"?Senators, you know that before yesterday, there was no need for such a transparent conciliatory gesture. We know, that you know, that we know, that you know, and we don't worry about the clumsy looking timing. It's the base who are important, see, and now their mad at us. When mongo church membership balloons a bit more all your clucking and clacking will matter even less. [Behind his hand] Of course, if this doesn't fly, the President will simply approve me while you're all on recess assuring the voters with short attention spans of how tough you looked in your bold ties, crisp shirts and red dresses asking me these questions. I serve at the President's..pleasure, and being that this is politics, it's ALL political, all the time -- of course."
We're not surprised that the doctor didn't say this, but on the other hand, he seems to have a loose grip on these most obvious facts. How can we trust him to capably run the FDA? How could he oversee the approval of drugs, their safety and efficacy, how could he protect the health of Americans? How could he lead such and enormous, bureaucratic, entrenched agency, with such a pathetical level of political savvy? Unless this hearing, these questions, these tough stances are all kind of part of a political charade-like ritual that we knowingly revel in.
The Food and Drug Administration has successfully stalled the approval process of Plan B for years, refusing to allow the drug to be sold without prescription despite its own scientists' and independent review boards' recommendations, enduring leadership upheaval over its refusal, and successfully rebuffing outside insistence that the agency quit stalling. Scientists have verified safety data, and studies show that it does not change sexual habits (or pregnancy rates) in women. 45 countries allow women of all ages to access the drug without prescription. But while researchers have found Plan-B to be effective as a last resort for avoiding pregnancy, conservative religious groups say that the use of the drug without a prescription would have negative consequences such as promiscuity, drug use, or exploitation.
Acronym Required last wrote about Plan B and the FDA in FDA - Calling off The Dogs". At the time, Susan Wood had resigned as head of the Office of Women's Health over the FDA's denial of the Plan B application. A male veterinarian with no experience in women's health had just been assigned to take her place. Lester Crawford, another veterinarian, who briefly and tumultuously headed the FDA, had just resigned. The resignation was somewhat mysterious, but came in wake of the Plan B upheaval and uproar over his assignment of the male veterinarian to the woman's health division. He is now facing criminal charges of an undisclosed nature. Plan B medication is available as a behind the counter drug in some pharmacies in some states, but the FDA at the time seemed like it would successfully stall approval of the drug indefinitely.
The decision to withold Plan B was completely in line with the administration's antiquated, paternal "abstinence only" dogma, and runs counter to scientific advice. Yet despite this obvious chasm between science and policy, the very public political upheaval in the FDA about the decision, and the administration's blatant stance against birth control, the FDA flatly denied that the decision was about politics. The agency published a Questions and Answers" on Plan B on its website. The Q&A addressed politics in question #11, that asked, "Did the FDA bow to political pressure in making this decision?" The FDA wrote,"No. This decision was made within the Center for Drug Evaluation and Research." We thought the evasive "answer" was perhaps the quintessential "no" that said "yes" (with a wink and a nod). However this is political obfuscation of the facts and blatant denial that it's all politics, is so routine these days, hardly even gains attention.
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The FDA is planning talks with Barr Pharmaceuticals next week.
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Acronym Required previously wrote about the FDA:
"Resuscitating The FDA", about the FDA in the wake of various fiascos.
FDA -- Calling Off The Dogs, about Plan B and staff turnover.
Ethics- The NIH and FDA, about conflicts of interests among scientists in these two agencies.
