Tuesday, January 20, 2009


Greetings, Peanut Gallery. While we float in inaugural ether, In Vivo has posted a brief interview with Josh Sharfstein, whom they have reported as in the "top two" choices for FDA Commish.

Their latest story here:


Rather than speculate who will be the last one standing, how do people feel about Sharfstein as the choice? Some have raised objections related to his closeness with Henry Waxman. Some have celebrated him for the same reason (along with others).


  1. Justice of Michigan asks, “Rather than speculate who will be the last one standing, how do people feel about Sharfstein as the choice [for FDA commissioner]?”

    It appears that Josh Sharfstein is first in line for the job. I am delighted. Take a look at his achievements, here:


    President Obama stated in his inauguration speech this morning, “We will restore science to its rightful place, and wield technology's wonders to raise health care's quality and lower its cost...Those of us who manage the public's dollars will be held to account — to spend wisely, reform bad habits, and do our business in the light of day — because only then can we restore the vital trust between a people and their government.”

    Sharfstein – he IS da man!

  2. Personally, I hope you're right, Nancy! Yes, when I heard that part of the speech it was certainly FDA that came to mind (although there are other potential choices!).

    Do you or anyone have any idea where JS is on PDUFA? Bill Schultz, who is apparently first pick for HHS Senior Counsel, has generally defended it.

  3. Joshua Sharfstein should be Da Man! And, if that happens, he will be closely associated with his old boss, Rep. Henry Waxman--who will be overseeing the FDA. This is all very hopeful for those of us concerned about FDA preemption, as Rep. Waxman is concerned too.

    Here, in part, is his response to a letter I wrote him about FDA preemption.

    “…This decision [Riegel v Medtronic] has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval devices or inadequate safety warnings. It also removes one of the industry's most important incentives to maintain product safety after approval and disclosure newly-discovered risks to patients and physicians.

    The Court premised its decision on the theory that approval by the Food and Drug Administration (FDA) adequately protects
    patients from unsafe medical devices. That theory has proven false time and again. There have been numerous recent stories of patients
    who have suffered serious injuries from defective FDA-approved devices, like implantable cardiac defibrillators and pacemakers. Until the Bush Administration, FDA had always viewed state product liability cases as an important supplement to the Agency's regulation of medical devices and as an added layer of protection
    for consumers.

    Should the Supreme Court make a similar decision in the upcoming case regarding FDA-approved pharmaceuticals, you can be sure I am prepared to take corrective action.”

  4. I really don't know what to think about Waxman.

    He helped write the final version of the FDA Amendments Act of 2007. It only makes allusions to memo's of understanding with Pharma. Well these memos of understanding allow FDA to tell companies exactly what's going on in the review throughout the process. Reviewers can't even tell congress this even if there's corruption and collusion because it's part of the deliberative process.

    It also says you have to publish the approval package (i.e. the reviews) but allows redaction for trade secrets. If you look at the published reviews since it took effect entire sections have been deleted that clearly aren't trade secrets but are the lab work associated with clinical studies related to safety.

    There's also been a lot of leaks from Waxman's office. Look what happened to Andy Mosholder the reviewer who spoke to Waxman's people about pediatric suicides with antidepressants. I also have a colleague who went do there and showed then an FDA USB drive with info but said she was afraid of leaks. Guess what 3 days later FDA issued an e-mail telling everyone that it was illegal to copy any documents onto personal USB drives (of course Waxman's people wouldn't have known it was an FDA issued USB drive.

    I can go on but right now I'm taking a wait and see attitude about who's selected and what they do.

    Personally I feel most comfortable with Nissen. I don't agree with everything he's saying, but at least he has a track record about going after some of the worst toxicities we see. I agree with him that we need more money for things like the food division etc., but I think we should get away from user fees and instead get special targeted taxes on the various industries regulated. This way it's not he who pays the piper calls the tune.

  5. I really do believe in what Obama has committed to in the way of putting the emphasis on science. It is not going to be an easy task to make sure the science is the focus in every step of the process in drug review. I have a wish list for the FDA and here are a few things I would like to see:

    1.) Absolutely no more ghost writing what-so-ever. If your name goes on the paper, then you reviewed, analyzed and absolutely agree with all the raw data from all participating sites, not just yours.

    2.) Major incentives for curative treatments, rather than therapeutic (could be tax incentives, etc.)

    3.) Re examine compassionate use. I am formulating an idea on this...

    4.) As with anonymous above, we need to work more on ensuring that we are not endangering citizens health with our food policies. Incentives should go for more nutritionally healthy foods that are also eco friendly.

    4.) Incentives to drugs and devices that are delivered to the market that are not only scientifically sound, safe for the consumer,and meet the criteria for performance but also provide a pharmacoeconomic value to the disease category.

    We need to find ways to make our system accountable again. We need to encourage innovation.

  6. FPME,
    As someone who has written numerous scientific papers, I can tell you that there is no conceivable way that every author on a paper is willing or even CAPABLE of "reviewing, analyzing and absolutely agreeing with all the raw data from all participating sites". Maybe within a particular clinical study, this is possible. But many scientific papers I write are so multi-disciplinary that, even as the senior author, I don't have a good understanding of the best interpretation of the raw data from some of my colleagues.

    What you are writing will only work within papers in a very narrow scientific discipline.

  7. A little off topic.

    Today Obama did a lot of talking about new rules for lobbying.

    "The rules also ban lobbyists from giving gifts of any size to any member of his administration."

    FDA came to mind. The relationship between drug companies and FDA being of a lobbying nature by the procedure for which drugs gain approval overall. It makes you wonder how lobbying will be defined during the Obama presidency. He was polarized on aides and staff members but are the new rules limited to them?


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