• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

From the Editor: Taking It Outside


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-04-01-2007
Volume 0
Issue 0

There are whistleblowers who bring wrongdoing to light. But there are also whistleblowers whose main complaint is "I should have won." FDA seems to suffer from a serious oversupply of the second sort.

FDA Commissioner Andy von Eschenbach said something pretty reasonable the other day, and in return received a blistering, menacing letter from Senator Charles Grassley—a letter that showed yet again that Grassley just doesn't understand (or perhaps doesn't care) what he's destroying in his campaign against FDA.

Patrick Clinton

In case you missed the exchange, here's what happened: Late in February, von Eschenbach spoke at an event sponsored by the Center for Medicine and the Public Interest. The next day, an article by Robert Cohen in the Newark Star Ledger reported his remarks like this: "[Von Eschenbach] said he is committed to insuring all different points of view within the agency are heard and part of the deliberative process. But he added he won't tolerate whistleblowers who go outside the agency just because they disagree with a final outcome. 'The people have to understand to go outside that process is not constructive. It is actually destructive,' von Eschenbach said."

Needless to say, as soon as the article appeared, whistles started blowing in Grassley's direction. FDA staffers and others told Grassley that von Eschenbach's remarks were being interpreted as a prohibition against speaking to Congress and a threat to fire employees who didn't play along.

And that, Grassley pointed out, would be a violation of US law. "FDA employees, like employees at any other government agency, have the right to talk to Congress," he wrote. He admitted he wasn't sure von Eschenbach was trying to interfere with that right, but that didn't stop him from suspecting.

"Your actions to discourage FDA employees from talking to Congressional investigators or otherwise 'going outside the agency' or 'talking outside the locker room' make me wonder what it is FDA is trying to hide," he wrote. "Sunshine is the best disinfectant. If there are problems at FDA, I assure you concealing them is not the solution."

Nice rhetorical gambit, Senator, but let's be realistic for a minute. Von Eschenbach wasn't talking about blocking legitimate testimony before Congress. He didn't even seem to be talking about whistleblowing in its truest sense: revealing secret wrongdoing. He meant something quite different: FDA employees who run to the press not because an impropriety has taken place but because they don't happen to agree with the decision the agency reached.

It's no surprise there's disagreement within FDA. The drug approval process is intrinsically adversarial, pitting risks against benefits, and the interests of patients who might be helped by a particular drug against the interests of those who might be harmed. In many cases, one side is going to win and one side is going to lose—and given the desire to allow patient choice, the side that loses will often be the side that opposes approval. That's not malfeasance. That's life.

But to turn the process into a public circus, the way some recent FDA "whistleblowers" have done, is harmful. It exaggerates the risks of useful drugs, sends a distorted message about the regulatory process, and unreasonably undercuts FDA's authority.

I suspect Andy von Eschenbach would love to be able to shut his employees up. I'm confident he knows it wouldn't work. In the long run, we need FDA processes clear enough and fair enough that even the employee who loses a battle feels no need to take it outside. We don't need an FDA where everyone agrees. But all of us—the public and the industry alike—need to be able to hear what the agency says free of the sound of whistles.

Patrick Clinton



Related Videos
Related Content