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November 15, 2005

Plan B: Ignore Science, Destroy Evidence

The saga of malfeasance at the Food and Drug Administration over the emergency contraceptive Plan B just keeps getting worse, as detailed in today's New York Times. (Find earlier episodes here.)

The Government Accountability Office, a nonpartisan investigatory arm of Congress, has released its report on how FDA has handled Barr Pharmaceuticals' application to sell Plan B over the counter.

The findings are damning. Among them:

  • Well before FDA scientists had evaluated Plan B, according to GAO, four senior FDA officials were told by their superiors that Plan B would be rejected.
  • Top FDA officials intervened in agency decisionmaking, overriding the recommendations of expert review panels and agency scientists, in ways that were "very, very rare."
  • The rationale given for overruling those scientists was "unprecedented."
  • All of former agency administrator Dr. Mark B. McClellan's emails and other correspondence about Plan B were destroyed, in apparent violation of federal rules.

GAO is notoriously careful in its wording. So it wouldn't be unreasonable at this point to read into these carefully modulated terms official confirmation of our worst suspicions: the Bush Administration's appointees at the FDA ignored the science and ran roughshod over one the most respected and impartial federal agencies to placate its political base. Then it launched a cover up.

Are we getting close to the territory reserved for special prosecutors?

I make these strong charges without partisan rancor. The intensity of my indignation is fired by the knowledge that ready access to emergency contraception reduces both the abortion rate and the teen birth rate. Every month that passes without over-the-counter emergency contraception means more unwanted pregnancies. Unwanted pregnancies lead overwhelmingly to abortions, which--no matter how strongly you support the right to choose--are no one's idea of a public good. To a lesser degree, they lead to births--births of babies who tend to be poorly cared for and at great risk for all manner of ills. And these unwanted pregnancies all could have been prevented with emergency contraception.

As if that tragic waste weren't enough, there is the horrifying prospect of a thoroughly politicized FDA. Let your imagination extend this precedent from emergency contraception to all manner of other pharmaceuticals and, I suspect, you'll share my deep concern.

Posted by Alan Durning | Permalink

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Comments

I sincerely do share your deep concern about this issue.

And maybe it's because my grandfather was an obstetrician-gynecologist that it also concerns me when someone uses the harsh words of "unwanted pregnancy," as used above, rather than the gentler words of "unintended pregnancy," as used on NARAL Pro-Choice America's website

http://www.prochoiceamerica.org/womenarewaiting_web/index.html

Thanks for caring about this important issue, Alan.

Posted by: Michelle Parker | Nov 17, 2005 11:56:54 PM

I think a unintended pregnancy is also an unwanted pregnancy. Opposing plan B doesn' make any sense. Easily getting a pill to "generally" prevent a pregnancy soon after sex is much more preferable to someone having an abortion later. No matter if you do or do not support the women's right to choose, this pill should lower the number of abortions if it was easily accesible.

Posted by: Gary Durning | Nov 18, 2005 12:42:26 PM

Good point, Gary.

In my opinion, however, I believe that using the emergency contraception pill for an "unintended pregnancy" helps to re-emphasize the point that the pill is for *emergency* purposes only.

I believe that the "regular" contraception methods are the ones to be framed as preventing the "unwanted pregnancies."

Posted by: Michelle Parker | Nov 18, 2005 1:25:16 PM