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I don’t normally read the Washington Times, but did see a headline on Findory and had to see what they were saying. Basically, the editorial says that Bush should use a recess appointment for Dr. von Eschenbach as commissioner of the FDA.

A chief for the FDA - Editorials/Op-Ed - The Washington Times, America’s Newspaper:

I find this article to be misleading and very counter-productive. The FDA needs a strong clear leader to be able to fight for the agency on capitol hill and to set a direction for the agency. Having someone in charge who was appointed in a round about way to avoid congressional approval certainly won’t start him off on a good footing with Congress.

The editorial makes a lot out of Dr. von Eschenbachs credentials and I don’t think anyone would debate those; it’s a way of creating positive spin without dealing with the real issue. That is will the agency be making decisions based on strong scientific evidence from the experts in the field or will they be used for political pandering. Note that I avoid the term “sound science”. This phrase is a republican code word for “only science that agrees with us”. For more on this, read “The Republican War on Science” (Chris Mooney). He talks about this in chapter six.

I hate to even quote from the article and give them more exposure but feel the need to correct some misrepresentations.

But leadership in limbo undermines authority. It has made it hard for the agency to move forward or respond to congressional overseers who are more interested in promoting their careers than the public health.

How does poking your finger in the eye of the very folks who are overseeing your agency give a leader any authority? I think the senators are indeed protecting the public from the FDA making poor decisions based on politics rather than solid scientific evidence. The former commissioner has admitted under oath that he violated the agency’s own procedures and processes by making a unilateral decision counter to the scientific experts within his own agency.

The holdup can be blamed on Sens. Hillary Clinton and Patty Murray, who, as today’s Op-Ed “Distorting science” notes, are blocking his nomination until the FDA agrees to make the contraceptive Plan B, or “morning-after” pill, available without a prescription and without any restrictions on age or access.

Neither senator has ever said the FDA MUST APPROVE Plan B. They have said the FDA should make a decision one way or the other. Here is a quote from Hillary Clinton and Patty Murray which makes this clear:

For more than two years, the FDA has dragged its feet on making a decision, putting ideology over science. It is past time for the FDA to stop dragging its heels and make a decision on Plan B. We will place a hold on the nomination of Dr. von Eschenbach until the FDA issues a decision on Plan B, yes or no.

Here is a quote from Patty Murray:

“This time around, we are being very firm,” said Sen. Patty Murray (D-WA). “The FDA needs to follow its own rules and make a decision, yes or no on Plan B, and their credibility is at stake. We will hold up this nomination until that decision is made.”

The FDA had said they would come to a decision in a certain timeframe but then didn’t meet their own self-imposed deadline. This fiasco has been going on over three years. I also don’t think either senator has ever said there should be no age restrictions. The FDA keeps delaying making a decision and the announcement just one day before the hearing was another example. It only brought up new issues that could be used to further delay any action.

The FDA and Dr. von Eschenbach have decided that women 18 and over should have such access while younger women can still get it with a prescription.

That isn’t quite true. The FDA has asked Barr Labs to meet and have further discussions concerning these issues. No decision has been finalized. Here is the quote from the FDA’s website:

In the letter to Duramed, the Agency communicated its plan to proceed working with the Sponsor in order to move Plan B from prescription only to over-the-counter status for woman ages 18 and older.

Note that Duramed is a subsidiary of Barr Labs.

The senators don’t want a permanent commissioner. They want a decision that makes their base happy.

This is a case of the pot calling the kettle black. The whole reason the FDA has dragged their feet making a decision on Plan B is due to political pandering of the current administration to the religious right. This is what these Senators are trying to prevent. It should be noted that Dr von Eschenbach is a personal friend of President Bush.

Capitulation to this ransom demand would open the FDA up to political manipulation of the rankest sort. This is not about science and health. If it were, Dr. von Eschenbach would be confirmed in a heartbeat. This is about attacking the administration, just as its opponents did when they blocked John Bolton’s nomination as U.N. ambassador.

The FDA has already become politicized. What the editorial meant to say was that this would prevent the agency from becoming more politicized in the direction that the current administration wants.

Here is another illuminating quote from an article on US Medicine.com. Note this was written in April 2006 before the recent confirmation hearings. Although a timeframe for the confirmation hearing was set, there is no such corresponding timeframe from the FDA on when they would make a decision.

There is not as yet a timetable for confirmation hearings, or one for FDA to make a final decision on the Plan B application. A considerable amount of criticism has been directed at the agency for its handling of the application-both from Congress and from a number of professional medical organizations.

A Government Accountability Office (GAO) report released in November documenting GAO’s investigation of FDA’s handling of the Plan B application showed a number of inconsistencies in that application review process, and included testimony from several FDA officials that they were asked by superiors to withhold their support of the application for reasons they believed to be political rather than medical.

Here’s a link to the whole GAO report. I think the fact that the GAO report says that people within the agency felt the process was political rather than scientific means this nomination should indeed be held until after the FDA makes a decision on plan B.

Other Resources

• RedOrbit - Health - EDITORIAL: Time for Plan B: An FDA Nomination Held Hostage for Understandable Reasons
• FDA Candidate’s Future Depends On Morning After Pill’s Fate
• FDA Chief Calls For Meeting With Barr Subsidiary, Says Age Restriction In Nonprescription Plan B Application Should Be Raised To 18

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