FDA, the Commissioner and Plan B

Apparently now it is being reported by the Minneapolis Star Tribune and Associated Press that Dr. Lester Crawford is stating that there was no attempt to disallow Plan B’s switch from RX to OTC, but rather that he delayed the switch with the idea that the agency would have by now acted, he said in testimony .  He stated this his concern was about how the OTC switch would work to allow 17 year olds to purchase the drug, but keep 16 year olds from doing so and having to go the prescription route. 

According to the report,

"Crawford said he had expected the FDA would take six to nine months – "tops” – to work out the enforcement issue following his August announcement. Crawford abruptly resigned from the agency the next month; nearly nine months later, the FDA still has not announced a Plan B decision."

That raises a number of interesting questions, some of which have already been asked by QDIS

But now even more questions arise rather than are answered. 

  • Why was the letter to the sponsor not signed by Dr. Crawford if other staff had been taken out of the picture?
  • Why hasn’t Dr. von Eschenbach acted to restore FDA credibility and assure his Senate approval by acting to approve the switch?
  • Most importantly, why is it set up that an FDA Commissioner can wreak this sort of havoc not only for a drug sponsor, but putting the credibility of the agency at stake? 
  • Is the Administration planning a recess appointment to bypass the issue, an action which will only serve to further erode the credibility of the agency and undermine the authority of the future Commissioner?

Quoting further from his deposition, the article stated:

""I made a decision that that was correct. What I could not decide on is whether or not I could stand before the American people and say this will be successfully enforced. That I could not decide,” Crawford said in his deposition. "

But there is another question now before the American people and before the many women who may have needed Plan B with OTC access by now, but had to instead deal with the consequences.  That is why can a Commissioner be allowed to singularly sidetrack the scientific process of the FDA and derail the process because his personal concerns trump the judgment of the advisory committee that considered it?  Can he stand before them and explain it? 

What if, during the wretched time that the AIDS epidemic was being researched for protease inhibitors, a Commissioner had considered that a treatment would "encourage promiscuous behavior" among people at risk, not unlike those who oppose needle exchange argue that the practice condones drug use?  How many would have suffered.  Is this the power an individual should hold?

A great deal of attention has been placed on the potential conflict of interest of members of the advisory committee and their ties to research with pharmaceutical companies.  Perhaps some of that attention should be addressed to this question instead.  Congress should act to limit the Commissioner’s future ability to do so. 

For links to Dr. Crawford’s testimony click here.

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One Response to FDA, the Commissioner and Plan B

  1. Ed Vawter says:

    Mark, great comments and I have some of my own over at my blog.
    http://www.qdinformation.com/qdisblog/2006/06/15/ex-fda-chief-crawford-meant-to-ok-plan-b/
    Maybe Dr. Crawford should talk to the folks over at the Bureau of Alcohol Tobacco and Firearms to see how they deal with determining someones age for sales of cigarettes or alcohol. That excuse is just ridiculous.