Imagine (we all have bad dreams from time to time) that you've been appointed FDA Commissioner.
You know, of course, that your immediate predecessor lasted in the job barely 60 days after his confirmation, resigning under suspiciously mysterious circumstances. And that in a recent Wall Street Journal poll seven out of 10 adults give FDA a negative rating, while 82% claim its decisions are influenced by politics.
Next, four senators, two Democrats then two Republicans threaten to hold up your confirmation unless you do their bidding.
With enemies like that you surely need friends, but brand new in your job you encounter friendly fire: an Institute of Medicine report requested by FDA itself charges that the agency has a deeply flawed drug safety system and is riven by fierce staff disagreements.
In the midst of all these tribulations you're due to give a talk in the heart of pharma country in New Jersey. You pick a topical but safe topic: “Molecular Metamorphosis and Personalized Medicine.”
Let the media make a headline out of that!
Actually, if the media were concerned about more than controversy and scandal, they could have come up with quite an attention-getting headline: “Acting FDA Commissioner Reveals Ambitious Agenda,” for that is essentially what Dr. Andrew von Eschenbach did on Sept. 14 at Seton Hall University's first Pharmaceutical Leaders Forum. He made four critical points:
• “The FDA of the past is woefully inadequate.” Hence…
• “We have an imperative to change.” Because…
• “We are on the cusp of a transformation so profound that…it will change the lives of millions of people.” This transformation was triggered by the discovery of DNA and has led to “nothing less than the unraveling of the secrets of life.” Therefore…
• “We need to develop a healthcare system that makes the most of this new era of pharmacogenetics,” and FDA and industry “must walk this road together.” FDA must realign its regulatory responsibility with the molecular revolution, and industry must adapt accordingly.
“This is the work and the quest we need to undertake,” he challenged his audience, adding that we have no choice in the matter; our only choice is in shaping the outcome.
Citing specific steps he is committed to undertake, the commissioner called for seamless collaboration of FDA with the National Institutes of Health, and making the still-evolving Critical Path initiative (See “FDA at 100,” MM&M May 2006) operational. At the same time he confirmed that the agency will continue its primary commitment to assure drug efficacy and safety, with emphasis on post-marketing surveillance.
What is more, he said in response to an audience question, as we develop new life-enhancing interventions, we must make sure that access is fair and equitable—and do all that in the face of the ruptured bond of trust suffered not only by industry but by the healthcare enterprise overall.
Achieving these objectives is the tallest of tall orders, but Dr. V—given his vision, his experience as a clinician, teacher, cancer researcher and head of the National Cancer Institute—seems to have all the necessary qualifications. The only other thing he needs is a bit of luck. For the sake of the FDA, the industry, and the nation, let's wish him lots of it. Starting with confirmation.
Warren Ross is MM&M's editor at large