Advice for the Obama FDA Commissioner, Part 2

It is important to understand that the restoration of the FDA will be a process and  not an event.  The Obama FDA Commissioner cannot simply come in and issue a few rules, send out a few press releases and change around some personnel and think that credibility will return to the agency.  He or she needs to set out a process that clearly demonstrates a departure from the status quo and one that, while demonstrating leadership, also signals inclusiveness and an overall goal to responsibly oversee one-quarter of the nation's economy by assuring the safety of food in a global environment and the approval of new medications to treat old conditions that have been rigorously tested and where there is transparency in the process.

So, here is my prescription for the FDA:

  1. Enact a digital strategy along the lines of that described in the last posting.  Without a digital strategic aspect to your communications plan, you do not stand a chance of winning no matter who you are.  Without it, you are already signaling you are not interested in talking to people who matter.  Identify theelements and chart out the strategy and do it.  It isn't that hard.  Use if for both internal and external communications because both desperately need attending to.
  2. Acknowledge that there needs to be change and demonstrate that you are not only going to do it, but that you will seek the input of stakeholders – from drug makers to academics to policy-makers.  Immediately stage a series of policy meetings held open to the public.  Don't just listen to what they have to say, educate them about the issue first – state the FDA challenges from each stakeholder perspective, and get them to respond. 
  3. Remember, you have very little credibility left, so in a classic crisis communications move, you must borrow some.  Hold a series of symposia at high profile universities that will publish the results and aim the symposia at various problem identification and solution aspects of the FDAs operations.  Do one on food at a prestigious agricultural school, another at a public health school such as UCLA.  Hold one on drug development at Duke.  Hold one on public policy at Harvard.  Do all of these in the first year.  When you have, put the findings of these and the public meetings into a compendium that serves as the basis and rationale for a plan going forward.  Everyone will feel bought into it and all will have a better understanding of the unique challenges you face.
  4. Signal a new day to staff as well.  The FDA has suffered from a personnel aspect.  Assure the outliers they still have a place, but devise internal mechanisms for staff input so that they do not feel as compelled to run to a member of Congress when they have an issue, but to address concerns in an appropriate manner that ensures input is valued and acted upon.
  5. Whatever messaging grid or apparatus exists for the FDA, throw it out and begin again because the current one doesn't work.  Have an exercise with your top staff that devotes a day to this – I volunteer a day pro bono for this effort!  The message must put forward the benefits of the food and drugs that the agency regulates as well as what FDA does to address the risks associated with globalization and the push to find new treatments and cures.  Solid messaging is the very foundation of effectively communicating change.  If you don't have the messaging down, you can't win.  Ask John McCain.
  6. Get a lot of prescriptions for yourself and take your vacation time.  Your going to need both.
  7. Good luck, call if there are problems.

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2 Responses to Advice for the Obama FDA Commissioner, Part 2

  1. Denise Wills says:

    I find it encouraging to read an article that is both enlightening and truthful. I am concerned with what is happening in the drug development industry especially, the actions taken lately to move significant portions of manufacturing and management overseas in countries where there is little to no power to conduct freely. There are many ways to cut costs and control spending in clinical trials that will save millions of dollars. However, the uncertainty and added pressures from the FDA that have little to do with science are not helpful and only add to drug development costs that ultimately impact price points. The drug industry does not enjoy a positive image in the public’s eye, therefore, its imperative that all entities work together as suggested above.
    Denise Wills, President
    Extraordinaire Consultancy, Inc

  2. Mark Senak says:

    Thanks! I appreciate your appreciation!

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