Wednesday, February 25, 2009


Andrew Von E Joins Regulatory Consulting Firm

Wow, it just keeps on coming. Thanks to our loyal and intrepid participant Nancy Fruge, we learn that former FDA Commish AVE is already making his services available to a regulatory consulting firm. The link is essentially a puff piece, but it does convey the news.

This quick a move from FDA to industry consulting should probably lay to rest the notion of a "revolving door." Doors don't revolve that fast. Instead, perhaps we should just consider senior FDA positions a kind of lube job.


  1. Justice, I don't really understand your last comment. Did you really expect him to remain unemployed or go into some sort of non-health related job?? Of course it's a "revolving door":Once you get involved in an industry -- whether it's health-regulatory affairs or aircraft mechanics -- you'll generate connections, friendships, expertise, etc. and you'll remain in that field. Are you suggesting something improper going on?

  2. It's a good question, Nathan.

    No, I did not expect him to remain unemployed. But let's open the question to all. Here is the opening on Greenleaf's home page:

    "Greenleaf Health, LLC. is a full service regulatory consulting firm that provides strategic guidance to companies regulated by the Food and Drug Administration."

    OK, so AVE spends X amount of time as FDA Commish, a public employee drawing his salary from our tax dollars and accumulating (appropriately) the most "insider" knowledge of FDA that anyone can possibly get. We (the public) financed his opportunity both to serve and to learn in that role.

    Should there be no pause whatsoever between the opportunity to gain such knowledge and providing "strategic guidance" to private sector industries regulated by FDA?

    We know, and for good reasons, there is a mandated time between going through the door the other way--from, say, industry as client to FDA as regulator (Dan Troy put in his months). This has to do, of course, with potential COIs between serving one's (former) clients and being their regulator

    So--and this is genuine question--is there any sense in which propriety suggests some hiatus when one goes in the _other_ direction--from being the regulator of companies to becoming their "strategic guide"?

  3. Re: the question raised, happened to find the website of an organization that focuses on ethical issues involving the revolving door, including the government-to-industry direction.

    It is:


  4. Also relevant, the Lobbying Ethics Reform Act of 2007 which was co-sponsored by Senators Feingold and Obama (we've heard of the second guy).

    Among other things, the bill lists as a goal...

    "Increases cooling-off period for executive and legislative branch employees from one to two years. Former Members and very senior executive branch officials (cabinet members, heads of agencies) will be prohibited from engaging in lobbying activities as well as lobbying contacts for that period. This will prevent a former Member from supervising or designing a lobbying campaign while avoiding any direct contact with Members or staff."

    Yes, I understand that providing "strategic guidance" is not the same as lobbying. But it certainly may not be far away from providing services to those who do. And here we do, indeed, have a senior exective officer--the head of an agency.

    No issue?

  5. I believe if a former regulator takes a job within the industry in which he or she had oversight there is an immediate impression of a conflict of interest and it calls into question the integrity of the decisions made by these individuals while serving in their regulatory capacity.

  6. "Should there be no pause whatsoever between the opportunity to gain such knowledge and providing "strategic guidance" to private sector industries regulated by FDA?"

    Once again: What *IS* he supposed to do? They guy is an expert at heathcare regulation. Do you expect him to move into that fast-food buisness? His expertise is heathcare regulation, policy analysis, etc. Any field in which he utilizes his primary skill set would be a "conflict of interest" in your mind.

    Maybe we should mandate that public officials must retire and live on a government pension for 15 years after they leave public service...

  7. Nathan,
    Don't act so unaware, as in the D. Troy horse.

    When the FDA is already accused of being too cozy with industry this move, whether innocent or not, is brazen and foolish. Given Von E's performance as commissioner I suspect his work will be anything but innocent. Only time will tell.

    To your question about what he should do, I would answer - anything besides what he is doing.

  8. A few comments from a past article on Pharmalot about Von Eshenbach's leadership focus, whether direct or indirect -

    Whose side are you on?

  9. Jayneday,
    Your final statement makes my point crystal clear: "To your question about what he should do, I would answer - anything besides what he is doing." So you want him completely out of healthcare policy and regulation, right?

    That's like telling a police officer that once he/she leaves the police force, they can't work on anything related to law enforcement or security operations. That's just illogical -- the guy should be allowed to make a living in the field of his training and expertise. Frankly, from what I read, he wasn't liked too well at the FDA so it's unclear to me what he would really have any influence at the FDA.

    Let's also be very clear about what a "consultancy company" is: These are companies that pharma / healthcare companies approach to get an idea of what type of information, documentation, analysis etc. is important in decision-making. Contrary to your beliefs, pharma doesn't have "inside information" to the operations at the FDA and other worldwide regulatory agencies. Rather, we rely on speaking with former employees of the regulatory agencies by way of these consultant groups. This allows us to better gauge what type of drugs we should be pursuing and what type of clinical trial data would be required to support particular claims of efficacy and safety. This is vital information to us - without it we can waste tens of millions of $$ on clinical trials that are unnecessary. Generally, pharma is trying very hard to talk with the FDA (or FDA consultants like this group) along with payers (insurance agencies, NICE, etc) early I the process (~phase 2) in order to get an idea of what sort of phase 3 trial we should design to maximize our chances of approval.

    This isn't a game. These are people’s lives and health that we are talking about. These are billions and billions of $$ every year down the tubes (that YOU pay for) and people continuing to suffer unnecessarily when we waste time on the wrong clinical endpoints or on the wrong indication. We'd much rather kill projects sooner based on feedback from these consultants than continue to spend money on them and see them die at the FDA after we've spent 10 years and close to $1 billion.

  10. Glad to see some heat here!

    Nathan, the law is clear that certain kinds of moves between industry-gov and gov-industry are not permitted. You write as though there were no issues at all involved in moving from one to the other; as though such laws did not exist. And as if I'm sending AVE into the toy business. (Where have other former FDA Commishes gone?--the ones I think of Kessler, Henney, are at academic medical centers. They did not have to give up their careers. Straw man argument.

    I find your second post gets more to heart of it. I _agree_ that informed consultation between industry and FDA re: regulatory issues is generally in the interest of efficacy of all concerned--industry, agency, and public.

    That said, the_nature_ of that consultation, and its parameters, has been a subject of debate for many years.

    Obviously, industry does not need AVE in order to know the "latest" on regulatory requirements. They already have in-house folks in spades who are recent FDA "grads."

    What is different here is that AVE was a political appointment. His ties were as much to the former administration, and political alliances, as to the agency. I do not think he can be considered the same as other former FDA people, nor would he be so needed, as above.

    That is why his move, while not the same as the kind that involves immediately becoming a lobbyist, is not entirely different either.

    So I think your categories are much too black/white, all/nothing.

    I also think--regarding other posts--that AVE's particular virtues or vices are beside the point.

    Anyway, glad to see the discussion.

  11. Nathan, Von Eshenbach has not shown himself to be a supporter of the FDA I would like to see. Therefore I doubt his intentions as an industry consultant.

    Absolutely this is not a game but the FDA and certain pharmaceutical companies seem to be making it a game. A deadly game.

    You've seen the daily reports of industry "gamesmanship". It's about time it stopped. Von Eshenbach's entry into the consulting environment will possibly (we'll see) move industry up to skill level 2 in the FDA/pharma drug and device approval fiasco.

  12. a p.s. to my last post - Forgot that Mark McLellan moved from FDA to Medicare/caid, a kind of lateral move within gov. He is now a fellow in economics and health policy at Brookings. Like AVE--and essentially all of the other recent FDA Commishes (who were appointed, not acting)--he also had a strong background in academic medicine and research.

    Since there will be a new Commish at FDA itself, and other changes in politically-appointed positions (Chief Counsel, etc.), I am less "concerned" than Jaynesday about negative consequences, and less "enthused" than Nathan about positive consequences, resulting from AVE's new job.

    To me, it is more a question of being clear on the boundaries of ethics and propriety in "revolving door" issues. Once again, this is not some private whim. There are existing laws that regulate some such moves, and many believe (including both major candidates in the last election) there is more to be done.

  13. Here we go.

    Found this on one of the better pieces on AVE's new job. It defines some of the legal limits within his new role. Sorry I've lost track of the link. But I guess the main point is that there are, indeed, limits, which was useful to me to learn.

    We can productively discuss whether such regulations are good or bad, but not whether they exist.

    "Of course, as a former government official, von Eschenbach is restricted in the work he can do as an industry consultant. For the next year, for example, he cannot advocate directly to FDA on behalf of a third party. And he has a lifetime ban on lobbying the agency on the rules and regulations upon which he worked on or influenced while he was commissioner."

  14. Thank goodness.... but I doubt that he would need to lobby to change many of the rules and regulations he worked on. Apparently they have already favored the industry.

    I guess it's best to take care of industry when you are on the inside.


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