The Muzzling of the FDA

How government press officers stole our freedom

It is 1978. I have just been refused admission to a Pharmaceutical Manufacturers Association section meeting that is to hear FDA commissioner Donald Kennedy speak in a Crystal City Marriott conference room.

Outside the closed door, I see the commissioner bound off the escalator and stride toward me. He stops, looking puzzled.

“Hello Jim,” he says. “Why aren’t you inside?” Reporters usually sit in the front row, under the lectern, when Donald Kennedy addresses meetings.

“They won’t let me in,” I say.

“Then I won’t go in, either!” Kennedy responds as the door opens and the meeting’s managers surge out to greet their keynote speaker. I hang back, respectfully, just out of earshot as he talks to them. He goes inside and one of the managers comes back to me and says, sulkily, that I can go in but I must leave when Kennedy does.

Now it’s three years later, a few weeks after Ronald Reagan’s landslide victory, and Jimmy Carter’s second FDA commissioner, Jere Goyan, has been exiled by the transition team to a store-room full of cardboard cartons, a small desk and no telephone.

I walk in on him and because I have nowhere to sit, the conversation is short. His only regret about his 18 months as commissioner, he reflects, is he never got used to being in a “a goldfish bowl” all the time, meaning people like me and others could confront him almost any time.

I go upstairs and walk in on the acting commissioner, Mark Novitch, whose door is open. He’s glumly staring out at the wintry landscape below.

“How’s it feel to be commissioner?” I ask jokingly. He continues his poker-faced reverie. “I just hope they don’t undo everything we’ve done,” he murmurs before turning to face me. “And don’t print that!” He knows I wouldn’t - we’ve had a warm relationship for the past five years.

Fast-forward 18 years, to another industry meeting, in another hotel. Bill Clinton’s new FDA commissioner, Jane Henney, is sitting alone in the front row, waiting for the meeting to come to order and to be introduced as the keynote speaker. I approach, and sit one chair away from her.

“Hello, Jane,” I say (I’d known her when she was David Kessler’s deputy commissioner a few years before), “can I have a few words?”

Stone-faced, she turns slightly toward me.

“I really can’t talk with you,” she says frostily, “unless you go through the Press Office.”

The change in such media-agency relationships has been incremental, occurring so slowly since physical security and escort rules came to all federal buildings after the Oklahoma City bombing, that few of us noticed it. But at least we could still talk directly with our contacts on the telephone.

Soon that began to change. One by one, contacts we’d known and worked well with for years retired or moved out of our sphere of coverage, and were replaced by people who often seemed frightened to talk with us.

Increasingly we were referred to the FDA Press Office, staffed by people we liked and who did their best for us, but who had previously understood that their role was to help mass media, not trade press who were assumed to not need their help because of our intimacy with the agency and our beats.

By the time George W. Bush came into office, our isolation from trusted, confidential sources had become almost complete. Not a single word of notice for this change had been given to us.

When Barack Obama was elected, partly on a promise to “open the government,” I cultivated what I thought would be the enabling friendship of his choice for FDA principal deputy commissioner, Joshua Sharfstein. We got on well, with me sharing our vast electronic database of FDA stories with him, helping him “come up to speed,” and conversing by phone and email several times a week for the first six months of his FDA service.

But he, too, soon began following the Henney line - if I’m going to print anything about the information he shared, I’d have to go through the Press Office. I did that, but the head of that office, George Strait, wasn’t helpful. “The so-called ‘trade press’,” he sneered in one exchange. Meanwhile, the people staffing that office turned over completely, and few knew me or cared about my role in FDA journalism.

I was too independent for them and resisted the rules every other reporter apparently had succumbed to. Strait once allowed that he saw the office’s job as “to spread the good news about FDA.” Obviously we were at cross purposes because I’d never seen that as anything I wanted to do.

Later, Strait was sidelined and replaced by politicos Beth Martino and Meghan Scott, neither of whom was responsive to me. My inquiries would be processed sometimes, not at all other times, interviews were withheld, or if allowed were monitored, my written questions were screened and answers when given were expressed in stiff, non-conversational bureaucratic English.

Informed human-interest, color and context left my writing. After 35 years of insider contacts and reliable, exclusive FDA reporting, I’d been all but shut down by the FDA Press Office. As in the old Soviet Union and Communist China, they are in control now.

All without a word of prior notice or “due process.”

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Jim Dickinson is editor and president of Ferdic Inc., publisher of three FDA-oriented trade publications, and Washington columnist for two trade journals. Tags: ,