Editorial | Published:

An impossible job

    Nature Biotechnologyvolume 23page1321 (2005) | Download Citation


    The departure of US Food and Drug Administration (FDA) Commissioner Lester Crawford was sudden and unexpected. Though he told the media it was time to “ride off into the sunset,” it seemed more like a gallop for the hills under the cover of darkness, with a torch-carrying lynch mob in close pursuit. With Lester no morester, the world's most important drug-and-safety regulatory agency is leaderless once again. Readers pondering what it takes to be FDA commissioner are referred to Nature Biotechnology's version of the want ad below.

    US Consumer Agency Seeks Superhuman

    The FDA, an organization that sets the gold standard in the regulation of food and drug products the world over, seeks a new commissioner.

    Location: between Rockville, MD, and a hard place.

    The ideal candidate should have:

    Vision: Although the X-ray variety is not a requirement, you will need sufficient foresight to chart the course of individualized medicine in the 21st century while resolving awkward little conundrums like drug safety surveillance, generic biotech products, conflicts of interest on advisory panels, kickbacks from medical device companies, drug advertising, the pay-to-play fees that the FDA receives from industry as part of the PDUFA protocol, electronic drug reviews and public access to clinical data, to name a few.

    Reasoning: Superior scientific reasoning and deductive powers will be required. In short, we're looking for an individual with the genius of Dr. Evil, without Dr. Evil's ethics and links to the 'evil' pharmaceutical industry, with whom consumer groups like the Center for Science in the Public Interest and Senator Chuck Grassley will surely claim you're too cozy.

    Integrity: Saint-like, unassailable honesty and gritty determination a must. Your decisions will be based on science rather than political expediency. You would, for instance, never acquiesce to political pressure, undermining the advice of two of your advisory panels, and shelve a safe and effective drug like the 'morning after pill' Plan B.

    People skills: A Dalai Lama-like ability to inspire large crowds of people. FDA employs 9,000 people across the United States, many of whom are poorly paid, demoralized and looking for jobs in the industry you regulate. Your task is to change the culture and mindset from protecting FDA jobs to protecting and advancing America's health. Step up, Mr. Motivator!

    Wings of steel and pachyderm-like skin: Batfink-like appendages will come in handy to deflect sniping from lobbyists, special interest groups and single-issue politicians on Capitol Hill. Your skin should also be suited to mud slung at you from every direction on most days of the week (for reference, consult recent media attacks on Deputy Commissioner, Scott Gottlieb). Remember: forget any political aspirations you have. To do this job properly, you'll be making lots of enemies.

    Proven communication and negotiation skills: Pope John Paul II reached tens of thousands in his sermons; you will need to communicate clear and intelligible information about FDA-regulated products to over 300 million US citizens. Not challenging enough? You must also combat poor awareness of the small print on your drug warning labels and company direct-to-consumer propaganda campaigns seemingly designed to invent diseases and bamboozle citizens you're appointed to protect.

    But that's enough of ideals. In the current environment, the FDA is much more likely to be getting someone with:

    Distinctly conservative political leanings: Candidates are obliged to maintain an appropriate balance between strict application of scientific principles and strict religious observance.

    Megalomaniacal tendencies: As FDA head, you will be responsible for the oversight of products representing around 25% of the US economy; that's over a trillion dollars. The obvious products are the food and drugs, but you also get to oversee biologics, breast implants, cosmetics, animal feed and veterinary medicines (thankfully no pet food or pet treats). And did we mention microwave ovens, color televisions and cell phones? That's right—yours, all yours!

    A degree in bookkeeping and a penny-pinching attitude: You only have $1.6 billion to look after the well-being of the entire United States, so don't go trying too much of that innovative stuff.

    A reactionary demeanor: Exposure to relentless media and political criticism will condition you to be extraordinarily cautious and conservative. If your predecessor is anything to go by, you'll develop an increasing affinity for black boxes (45 black box warnings issued from January to June 2005 compared with 9 in the previous six months).

    A love of ambiguity: Keep 'em guessing. It's possible you will need to be flexible and indecisive, or perhaps just flexibly indecisive. You decide. Or rather, don't.

    Languages: Talk science to the politicians, and politics to the scientists. Confuse everyone.

    In short then, the job of FDA commissioner demands a cunning, compromising, obfuscating strategist. If that sounds like you, you could be looking forward to:

    • A full diary and Rolodex.

    • A life of plenary addresses. FDA commisioners are much in demand on the speaking circuit, even more so when you retire (and then you can get paid for it, too).

    • Rapid retirement. This is not a job for life, only for as long as you can stand it. Try the post for a few years as caretaker. Then take it on full time for a couple of weeks when you are ready. Leave the US public in the lurch when the going gets tough or the politics change. Ivy League colleges are always looking for deans (but the bottom has rather fallen out of the tobacco consultancy game these days).

    Candidates should apply to Andrew C. von Eschenbach, the latest temporary incumbent, whose current hobby is running a small research establishment called the US National Cancer Institute. Just remember, we want the very best people to work for the government (for a while at least).

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