Personnel decision

Who should be head of the FDA?

Ideally he should understand how drug development is drying up and have some decent notions about fixing it – this is probably the biggest current problem. He should understand big pharma’s sins and virtues. He should not be paralyzed by some stupid ideology, or be in someone’s pocket. And the usual – know something about navigating Congress and the bureaucracy, not have any really hilarious personal habits involving small woodland creatures.

Looking for names, but also qualities/experience to add to this list.

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80 Responses to Personnel decision

  1. sflicht says:

    I was going to say Andrew Lo (MIT Sloan) because he co-wrote this paper, but maybe one of the other co-authors (Leah Isakov from Pfizer?) would be better.

    Alex Tabarrok (GMU econ) might be a good choice.

  2. Mel H says:

    This is a serious discussion. I am trying to give it serious consideration. But that’s a bit difficult while one corner of my brain is shrieking in indignant protest that “He” should be whoever is most qualified without presumption of gender.

    sigh you’re really not helping, brain.

  3. medicine_is_not_about_healing says:

    Robin Hanson

  4. pollux says:

    Derek Lowe of In The Pipeline, perhaps. I’m not sure whether he can solve any of the problems, but he clearly understands them.

  5. Steven Ruggles says:

    Dr Ben Carson. It may not take a brain surgeon, but it couldn’t hurt.

  6. dearieme says:

    He’s a bit long in the tooth, but Jim Watson.

  7. brendan says:

    The hard criterion is the first one. There’s this public company called Simulations Plus (SLP) – ADMET and PBPK simulation software – that was founded by Walt Woltsosz, a smart guy who with aerospace CAD background, who invented Stephen Hawking’s first speech tool, but anyhow, it’s clear from their reports that the FDA is pushing companies to do more pre-clinical and PBPK simulation, and to include the results, for credit, in regulatory documents. The firm’s customer count has been growing ~10-15%/year for some time. Demand for their consulting in which they help researchers use the software is growing fast too. Basically it seems like there’s lot of buy in to an idea that you think is doomed.

  8. Bob says:

    Richard Gere?

  9. ckp says:

    Martin Shkreli or go home

  10. Pincher Martin says:

    Just clone Dwight D Eisenhower for the national security positions, Calvin Coolidge for anything having to do with the domestic budget, H.L. Mencken for public relations, and everything should take care of itself.

    • gcochran9 says:

      I would be happy to clone Ike, although in today’s environment he might pose a risk for revolt, simply because he wasn’t crazy. But I don’t know how to do that yet.

      There’s a non-zero chance that someone might actually listen to this recommendation, if I/we can come up with someone reasonable.

    • While we are at it lets go back in time and muscle a few supreme court justices right before they strike down the McCain- Feingold Act, you know the one that actually would have given us real campaign finance reform. Ain’t nobody got the muscle to do diddly squat to control big pharma without honest to God campaign finance reform. Anybody who says otherwise is ignorant. Money talks loud and clear, especially when each and every senator and congressmen needs boatloads of cash if they are going to get reelected.

      • gcochran9 says:

        Apparently you don’t need to spend much money to get the Republican nomination, or to run a close race. A lot of modern life is a set of shared illusions.

        • albatross says:

          This isn’t crazy, either. After all, until last year, it wasn’t at all obvious that a Trump-stule campaign could get anywhere close to the white house in the modern political environment. If everyone else who runs for office raises tons of money first, it’s not nuts to assume that this is what you have to do to successfully run for office.

          • gcochran9 says:

            I remember some analyses of the influence of money on election outcomes. Accounted for something like a sixth of the variance.

            • I would argue that the Trump campaign is the exception to the rule on just how important campaign funds are in running a successful political campaign. In the vast majority of political races at the senate and congressional level huge sums of money are required for TV attack ads on the opposing candidate and positive name recognition for the candidate paying for the TV ads. There has never been a political campaign like Trump’s. Up to recently his campaign had paid more money for baseball caps than employee payroll. That is incredible. I don’t see his iconic campaign changing the way money effects politics except at the presidential level but we shall see.

              • Scott Locklin says:

                David Brat apparently only raised 200k versus Cantor’s 5m and won by double digits by not being a barking looney working against his constituency’s interests.

  11. O157 says:

    He/She would hopefully:
    -Lobby for more funds for the agency: Need more food testing Period.
    -Speed up approvals of generics
    -Propose drug pricing regulations to Congress so that the profiteers like Mylan and Valeant
    can never jack prices 1000%.
    -Preferably – No drug industry ties (So the fox will not be watching over then hens)
    -Organizational Experience and History of Getting Shit done.

    I would think an internal candidate would fit this bill. I’m assuming the FDA has enough talented people to draw from.

  12. Xenophon Hendrix says:

    Perhaps one of John Sununu’s kids. They all ought to be brilliant, scientifically literate, and have picked up some political know-how.

    Esther Dyson.

  13. ohwilleke says:

    I think we are about due for a career civil servant within the agency or relatively recently retired from it (ideally to academia), with a PhD or M.D. and probably a pay grade of either GS-15 or Senior Executive Service (SES), who has a reputation for integrity, for intelligence, and for getting things done bureaucratically, with some low profile political connections (at least to the ruling party but ideally to both political parties) in private life as well (e.g. through friendships made at a top college, a politician or top political aide parent, or friendships made while attending a top D.C. private school like Sidwell Friends or St. Albion’s or National Cathedral School).

    Few federal agencies call for more subject-matter competence to understand its functions well enough to run it well.

    • gcochran9 says:

      The problem is that the typical member of the set you describe is nuts. Members have a lot of incorrect ideas in their heads: in fact, you have to express support of those ideas or you are expelled. So, that means that every educational improvement plan pushed by the Feds fails: you can’t do anything realistic, or you would be a bad person. Every intervention in the Middle East fails: same reason. AIDs shows up, so we abandon quarantine: Fidel Castro deals with the situation 50 times better than we did.

      The Aztecs thought that the world would end if they didn’t keep cutting people’s hearts out on an industrial scale. They were crazy. But were they crazier than we are?

      • Sinij says:

        “The Aztecs thought that the world would end if they didn’t keep cutting people’s hearts out on an industrial scale.”

        Interestingly, I wonder why this didn’t put selective pressure on Aztec population?

  14. Perseid says:

    Bill Clinton – Rohypnol deserves a crack at blockbuster status.

  15. Andrew says:

    Someone who is unlikely to be fooled.

    John Ioannidis

  16. Lars says:

    small woodland creatures?

  17. benespen says:

    I’ve dealt with a few of the current folks at the FDA. Of those, Barr Weiner stands out as pretty good, but that may be a low bar [so to speak]. He strikes me as reasonable to work with, but nobody’s fool. I have no knowledge of his personal habits. However, you wouldn’t necessarily want to pull out of the ranks at the FDA, if the idea was to do things differently. On that subject, do you really want a new head of the FDA, or just a new head of CDER [or CBER, if we are talking vaccines], which in charge of actually influencing drug development?

    In my opinion, there is a great deal of technical expertise at the FDA, but a lot of it comes in the form of very young, very inexperienced young ladies fresh out of grad school. This is good, insofar as you tend to refresh the knowledge of the technical staff often, but also the technical folks often don’t know how things work outside of the university or federal agencies. I get the impression the really bright ones work a revolving door system where you bounce back and forth between the FDA and industry, and then set up a consultancy when you are done with that. I think it would help to know how you actually find a new drug, so one of these might be a good candidate. Unfortunately, I live in BFE, so I don’t know any.

    I’ve worked with a lot of famous surgeons over the years. None of them would work for this. Wrong training, for one, but also no scientific mindset at all. The top guys are great at fixing things in the OR, but when I still went to surgical conferences, I saw the same damn presentations by the same damn guys every year. Hell, I could give some of them by now. One thing they do have is balls of steel. Anyone who really wanted to change drug development would need be on the sociopath spectrum in order to ignore all the useless complaints from everyone who is either scared of the sky falling, or getting rich off the current system. Surgeons are all over that.

    It would also help to understand what the existing controls/roadblocks are in drug development, and not be stupid about what they can do, and what they can’t do. Right now, most anything that solved a problem once has become mandatory A good sense of practical probability would help reduce the regulatory burden without courting a PR disaster. Right now, we do a lot of stuff because we have always done that stuff, not because it has the highest probability of working.

  18. O157 says:

    Wait… I got it.

    Elon MusK

    Hands down favorite lol….

  19. dearieme says:

    Bill Gates.

    • DdR says:

      That’s actually an intriguing proposition. He’s very intelligent, somewhat wonkish, knows the pros/cons of capitalist industry, only motivated on furthering the common good. I don’t think he has any weird peccadillos hiding in his closet.

      • dearieme says:

        And unbribeable, no small consideration in that semi-political world.

        • TWS says:

          And Petty, vindictive, and holds grudges while rubbing it in the other guy’s face. As long as he won’t be held accountable. Other than that a nice guy.

          Watched him do it first hand.

  20. AllenM says:

    I will bike- Shinseki.

    Eminently sane, and with no skin in the game to protect.

    On the evil side, Mitt Romney- he is rich and enough of a doo gooder to try and make it work.

    Someone I know personally who would be an outstanding choice: http://uahs.arizona.edu/blogger/will-humble-mph

    Will would do the best job.

  21. albatross says:

    I don’t know enough to suggest any names, but I can think of a few qualities.

    First: To the extent that we’re wanting to continue doing drug development more-or-less as we’ve been doing it (which is what we know how to do), the new FDA chief should be someone who really understands the business. I’m not sure if it’s more important to focus on experience with the small companies that often do riskier development of new stuff, or the big companies that buy them up, but we want someone who really gets how FDA policies and decisions affect incentives for drug development. Ideally, we want someone who can think about a proposed rule change or new administrative procedure, and have some intuition for how that’s going to look from the perspective of the people risking their own money and time on trying to get new drugs to market.

    My not-all-that-informed intuition is that the biggest long-term impact of FDA actions is on incentives for future drug development, so it’s probably okay for him to be less capable in other areas if he understands this side of things.

    Second: He probably needs to have a strong science background, so he’s taken seriously by the employees at FDA, and so he’s harder to lie to. (Also, there’s a pretty good correlation between that kind of background and being smart. I’d cringe to see an MBA in this position.)

    Third: He needs to be willing to bring the hammer down (to the extent he has the power to do so) on companies that are behaving badly. That’s true both for fudging the safety data on drugs and for gaming the rules to extract an extra year or two of monopoly on them. (But I’m a lot more concerned long-term with fudging the safety record.)

    Fourth: He should probably be someone at the end of a very distinguished and successful career. You don’t want the FDA director thinking about making sure he’s got a future with PharmaCorp or in politics when he makes his decisions. Independently wealthy would be a plus.

    Fifth: He needs to have some experience running or being close to the top of a large organization, because otherwise, he’ll be tied in knots by the folks who know how to play the game and are supposed to be working for him.

  22. dearieme says:

    Mitt Romney

    • DdR says:

      This is also a good suggestion. Introduced Mass’s health care reform, independently wealthy, knows Washington bureaucracy, is a capitalist but pragmatic, etc.

      Who appoints the head of the FDA? The president? If Trump becomes President, I don’t know if he would want to nominate Romney given the current animosity between the two.

  23. MawBTS says:

    Is turbocharging R&D the only thing we care about? Josef Mengele.

    Re: improving the FDA in general, what do you think of this idea to strip it of its regulatory power and turn it into a non-compulsive “seal of approval”? The goal is harm reduction, but you could imagine ways it would improve our body of knowledge. PBPK modelling only gets you so far, we also tend learn a lot about drugs after they hit the market and start to actually get used. We lack that corpus of knowledge for drugs buried in the FDA’s 10 year backlog.

    See the comments for sharp criticism, as well as suggestions (I like the one about making FDA compliance optional, but with a heavy tax on non-FDA drugs.)

  24. Lee Wang says:

    Scott Alexander.

  25. Toddy Cat says:

    Peter Thiel

  26. swampr says:

    John Ioannidis +1

  27. SMack says:

    What’s the gag here? Because I’m having a very hard time believing this group is naive enough to think a) that the person you’re looking for exists, and b) that anything important would change if he got the job.

    Has no one seen Yes Minister?

  28. Brian says:

    Also for Ioannidis, but what could be gotten on the guy that’s bad enough that it would induce him to take the job?

    • SMack says:

      No need to dig up any dirt yourself. Just let the various individuals and groups who would surely combine to block his appointment take care of that.

      Which is not to say Ioannidis would actually be good. You’d just be trading one bias for another. With a guy like that, Phase II approvals would become less frequent than Winter Olympics.

  29. El Bow says:

    Get a CEO from some big aerospace company. Boeing or LockMart or something. They would have reasonable experience managing projects, but also a lot of experience cajoling the government. They would be less likely to have any prior ideological investment in how medicine ought to be run.

    Pick someone young so their brain is still pliable, get them some advisers to fill them in on specifics and keep them away from woodland creatures.

  30. panjukey says:

    gary johnson, quick, get him before he’s president.

  31. Deckin says:

    Why are we being asked this question?

    • gcochran9 says:

      You should be able to figure that out.

      • Deckin says:

        As someone hopelessly unqualified to give a candidate, the question of ‘why you want to know?’ seems more tractable. Wandering in blindly,
        1. There’s no push to replace the current FDA head before the next POTUS is inaugurated–the current one just took office this year
        2. After the election, the new POTUS will be looking for one
        3. Both candidates probably have teams out scouting for people to fill posts like this
        4. It’s unlikely people on H. Clinton’s team are looking for the advice of Dr. Cochran
        5. It’s also hard to imagine Dr. Cochran is abstractly pondering this particular position for its own sake
        6. Someone on Trump’s team has contacted Dr. Cochran about this?

      • Lars says:

        Who has you on speed dial?

  32. Visitor says:

    The question you are asking is very broad, depends on what the administration wants to focus on. drug development has diminishing returns compared to lifestyle/diet changes. If you are asking on behalf of you-know-who, then the desire may be more for a nameplate/pr face and Congressional experience not as needed (although temperament to deal with Congress is). Also depends if demand is for an MD or not.

    previous experience. Andrew von Eschenbach, FDA commissioner under Bush II. Manhattan Institute now.

    planet X nominee – Dr. Jill Stein (critical of FDA ties to industry, not anti-vaxx but anti-vaxx sympathetic which is good for the base.) I don’t think she would take it but she might.

    bonus surgeon general suggestion Dr. Michael Eades

  33. biz says:

    Elizabeth Holmes.

    I mean sure, she ran a 10-year dangerous medical industry fraud that was shut down by the FDA and bilked investors out of billions, but let’s focus on the important qualifications: she’s female and wears a black turtleneck.

  34. KarlJRhodes says:

    It sounds like it should be you, Greg. But unfortunately I doubt you’re interested.

  35. Cato says:

    I hear this guy is interested: https://en.wikipedia.org/wiki/Alfred_E._Neuman

    Most economists (I know! I know!) who have looked carefully at the FDA have concluded that it should be dissolved. Tort law is probably enough to keep food and drugs safe. Putting the FDA into the loop not only delays the introduction of efficacious drugs, but much increases their cost.

  36. ad*m says:

    Janice Hogan. She is the most successful FDA consultant I have encountered, an engineer and JD, knows the FDA inside and out, and understands the difference between what you need to say and what needs to happen in the FDA. She has an unblinkered view of both what the goals of the organisation are and how to get this almost immovable ship to change course. Is a female.

    In general, highly successful FDA consultants are you best bet. However, they are $$$$

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