From Walking Agency Halls to Being Denied Contact: How the Controls Came Down on FDA Reporters

 Jim Dickinson: “They want to control everything that is said about how they’re doing their jobs. We journalists are not in the business of giving them control. We’re just in the business of telling the truth.”

From Kathryn Foxhall: I did this interview with Jim Dickinson, editor of the newsletter “FDA WebView,” in November 2021 as part of the research for an article on gag rules and “Censorship by PIO.”

I’m publishing the longer version now as the controls on reporters seem to grow more pervasive, but a recent legal win shows there are things journalists can do.

I edited the interview slightly for length and clarity, with suggestions from Dickinson.

Dickinson continues to edit “FDA WebView.”

 COMING TO AMERICA

Jim Dickinson: I came to America in 1974 from Australia where they had very stringent police state types of controls on the press. And one of the reasons I came to America was to enjoy the freedom to the First Amendment which is unique in the world. No other country has anything equivalent to the First Amendment.

In Australia, it was – and still is, to the best of my knowledge – the case that government employees are not permitted to talk to the media. The only person who is permitted to talk to the media for a government department is the cabinet-level minister in charge of that department.

Just Walking the FDA Halls

Well, when I came to the United States in 1974, I was just staggered at the difference. I could go into FDA and talk to anybody I liked. Nobody really cared that I was in the building. There were five of us, I think, or six, who worked for newsletters. So mass media was not very much interested in FDA. We were the ones who regularly prowled the corridors for our respective employers, looking for anything that we thought would make a story of interest to our readers.

And we developed friendships with some of the more cooperative employees of the FDA. And we came to terms with them as to when they were off the record and when they were on the record. When we were on background and when we were not on background. [And] when we could come back.

I could just walk into anybody’s office and ask the secretary is so and so in and she would either go on the intercom or go into the office and say, “Jim Dickinson’s here. Do you want to see him?” And let me in. Sometimes, in fact, quite frequently, I would go into that office, or any office I wanted, to ask questions in, and the secretary wasn’t there. So, I let myself into the office. I would knock on the door. Sometimes I’d interrupt a meeting. I’d apologize and agree to come back later. But that’s the way it was.

……

Well, the press office in those days was operated under a totally different set of rules to what it is operated under today. Their job was to deal only with the mass media. They were only interested in dealing with high profile matters that might involve their bosses or the administration in some difficulty because of the vast outreach of the mass media. So that’s what they were set up to do.

We in the lowly trade press were expected to fend for ourselves and go around and get our own news. They were big picture people and we were little picture people. Our readers were basically beneath their contempt.

 Walking Parklawn Building

[The Parklawn Building] had 23 stories of FDA offices.…In those days each elevator lobby on each floor had a large, conveniently flat-topped trash can. And I would put my newsletters in a small stack on each trash can…as I went up, and sometimes some mischief makers would take the whole bundle and stick it inside the trash. But basically, that’s the way I got my reputation in the building. My products were free to everybody who was lucky enough to grab one of those newsletters….And people liked me. People liked the other five guys [newsletter reporters]….working there.

 The Mass Media Outlets

New York Times, Wall Street Journal and…Washington Post and television stations, they weren’t interested in routine, everyday regular coverage of FDA. They only went there when there were big blockbuster stories going on.

But it was the press office’s job to intercept them and to escort them and make sure they didn’t get out of their depth....

The ethic of the press office in those days was to help the working journalists in the building. Help them get what they wanted….They weren’t there to obstruct, obscure hide or conceal or massage and control the news…. And it was so in other federal buildings, because the press officer or director of media affairs or whatever it was, was usually a former working journalist….

[The mass media outlets] wanted all the help they could get. Interest of the mass media in FDA was transitory, at best. There weren’t any major ongoing issues that interested them in those days. I was there for years and years and years, but mass media journalists were not.

Generic Drug Scandal of the 1980s

And you know, a scandal like the Generic Drug Scandal would arouse a lot of interest

I remember the day that story broke. I was walking the halls of FDA. In fact, I was on the way to the generic drug office just by pure coincidence. And I heard these RUNNING FOOTSTEPS in the corridor behind me and there was Bob Wetherall, the Associate Commissioner for Legislative Affairs pounding down the hall behind me just as I noticed the lead investigator from the House Oversight Investigations Committee, hurrying toward me from the Office of Generic Drugs with a bundle of folders under his arm. Bob began bellowing at the investigator: “You can’t do this. You know you can’t do this. Just walk in and take our documents.” And [the investigator] turned around as the elevator arrived with a big smug smile, full of teeth, saying, “We’re doing it,” and skipped adroitly into the elevator.

FDA employees had been picking favorites among generic drug companies. For bribes--they were bribed--to advance their applications through the approval process while retarding their competitors’ applications. This was a huge scandal….

There was an FDA employee in Generic Drugs who interested me quite a lot because, I think, he had something to hide and that made him anxious. He was one of my regular calls. His name was Charlie Chang [branch chief in the FDA generic drug division] and he was in charge of applications in the Office of Generic Drugs. Charlie Chang was not literally, but figuratively, in bed with one particular generic drug company. And it was his files that were seized that day. They caught him red-handed and he went to jail. And there were several others. It went on for years. The repercussions, the trials and all that.

Then all of the mass media were suddenly riveted on the minutiae of FDA processes and whether they were adequately secure, who was watching who and all that sort of thing.…

That was one way that the mass media began to wake up to FDA. And the Wall Street Journal was the first major news outlet to appoint a reporter whose job it was to monitor FDA news. They had never dedicated a single employee to do this on a 24/7 sort of basis before. No major, major news organization did. Only the trade press did.

Gradually the fact that the generic drug program could be corrupted by regulated industry was not lost on the people who broke that story on Capitol Hill....

The Capitol Hill investigators were thinking. “Well, those drug people are doing this kind of stuff, what about the medical device people?” And sure enough, they discovered and unearthed stuff going on with medical devices. That was that way where people were doing favors for some companies at the expense of other companies. That came several years later.

Denied Press Credentials

In 1996, the whole open sieve that was FDA was shut down in the name of security because of the Oklahoma City bombing. Then 9/11 came along, and anything that wasn’t already shut down, then got shut down. And as the vise began to close on my activities there, I raised several issues with management. In fact, the FDA Policy Board met and agreed to hear my case. I wanted FDA to start issuing press passes to regular media people who were like me, there every day trying to gather news….I cited the example of the Pentagon. They have press passes. The Department of State has press passes…. This woman Associate Commissioner for Management at the Policy Board meeting with me …. She whispered to me out the side of her mouth as she was shuffling past me to return to her office (it was kind of tight at the end of the table at the door): “Over my dead body.”

Denied Ability to Call

Kathryn Foxhall: What about the thing about not being able to call anybody without going through the press office?

Jim Dickinson: Well, that happened very slowly. I was at a meeting once.…I went up to [an FDA presenter] afterwards and asked him…specific questions. And he said he was in a hurry, to give him a call at the office later that day. So, I did exactly that. By that time, something had happened inside his office. He was not aware of it before. But his secretary had been instructed that all inquiries must go through the press office. And I said, “I’ve just been at this meeting with him and he said to call him this afternoon.” And she just dug her heels in and said, “No, you have to go to the press office. There is no exception.”

….

And Not Getting Through to Your Source at All

Kathryn Foxhall: What about getting through? Even after you go through the press office, what about getting through to the press to the person you’re trying to speak to?

Jim Dickinson: Well, that became increasingly more difficult. The press officer, the PIO, would want to know all your questions first. And then they would deflect your approach by saying, “We’ll get back to you.” When WE get back to you, it’s not the person you’re trying to interview, that you’ve prepared the questions to ask that person. It’s the press officer, again, the PIO. And they generally do it in a cherry-picking sort of way where they answer some of the questions in their own way. They ignore other questions that you presented. And they give you not enough detail in the answers that they do provide. And if you want to have a second go at it, it becomes almost like trying to push a snowball up a hill. It gets very difficult. They don’t have enough time to expend on this one trade press reporter’s multiple questions to this one individual. They’ve got other things going on.

Changing to an Aggregator

Jim Dickinson: I’m still editing FDANews every day.

Kathryn Foxhall: And you’re still hearing the same thing from your reporters?

Jim Dickinson: No. The whole picture has changed. Instead of us being originators of FDA stories, which was what I started out doing, I’m now an aggregator of FDA stories about itself. And other words, I’m gathering other people’s products and aggregating them into an overnight bulletin, which our people [Dickinson’s subscribers] can pursue at their own discretion by following the embedded links that we put in the stories that go to FDA documents or to lawsuits or whatever else source document might be.

The nature of what I publish is completely changed, which has given me a rather cynical idea of the First Amendment, because the First Amendment’s literal words are: Congress shall pass no law abridging the freedom of the press. Well, I think my freedom has been abridged. If you want to fall back on the nitpickers here, it wasn’t Congress that did it. It was the FDA bureaucrats and they’re not Congress. They did it.

Kathryn Foxhall: But Congress funds the FDA every year.

Lawsuit

Jim Dickinson: Of course, but that’s one step removed from the actual wording and you get weaker and weaker as you attempt to argue this.

As a matter of fact, I prepared a lawsuit against FDA on exactly these grounds. I also filed a petition which took three years to answer in voluminous detail in a way that—surprise, surprise—found [that] FDA won.

But the lawsuit was pro bono by a prominent Washington law firm and they spent a year and a half researching what grounds they could have to bring a case for reporters’ right of access to government employees. And they came up with this legal theory – which I think has to be faulty and wrong somehow, but I couldn’t get past it – that I needed to have a number, preferably a number, or even one, FDA employee who was willing to get up on the stand in federal court and say, “I’d be happy to talk to a reporter if my boss would let me. But my boss will not let me.” Well, that’s the very antithesis of the pact that I as a working journalist have made for years and years with all of my sources. “Thou shall not be betrayed. I will not expose you. You can tell me stuff and you will never be hurt by it.” And now I have to go to these employees and say, “Would you go on the stand and say....[laughing].” It’s not going to happen. And it didn’t happen.

…..

But that was [the attorney’s] problem: I had to find a willing talker in FDA. And I did find one who dickered on it. She was in the Detroit district office. And I just couldn’t persuade her to do it. She wavered. At the time she was worried about her retirement in two years and whether she would be hurt in some way. Anyway, she bailed out. [Editor’s note: Legal analysis from Frank LoMonte has now said that journalists can now sue on their own accord. Investigative reporter Brittany Hailer did so and won a favorable settlement with good First Amendment language.]

Getting Most Stories from Documents

Jim Dickinson: It’s worse than Australia. I left Australia to enjoy the benefits of the First Amendment here in America. And I did enjoy them for years and years and years and built my company on it. And now it’s worse than Australia ever was.

Kathryn Foxhall: How many reporters do you have working for you?

Jim Dickinson: Two.

Kathryn Foxhall: And in general, would you say you get your sources from documents?

Jim Dickinson: Yes

Kathryn Foxhall: And what about advisory meetings?

Jim Dickinson: No, we don’t personally attend anything. Advisory Committee meetings? Yes. If they are on the internet. If FDA holds a meeting on the internet and we’re interested in it, we’ll cover it.

Kathryn Foxhall: Would you say it, like this [business] is viable, because if you do this as a service for people who are interested, it is worth their money [for] a subscription? Because theoretically they could go through all this stuff themselves. But it’s a service to go through all the documents, pick out the important....

Virtually No Talking to People In FDA

Jim Dickinson: We aggregate all the things that we think our readership base would be interested in and present it to them overnight each day in a single, solitary document that they can then follow up themselves with hyperlinks that we embed in the text.

Kathryn Foxhall: So, would you say there is virtually no talking to people in FDA?

Jim Dickinson: Oh, absolutely. If we communicate with FDA, and it is always by email, that gives FDA’s PIOs the option to ignore us. You know, even the PIOs have dragons at the gate to screen out reporters who want to get to talk to the PIO. [The person who answers the phone], says, “And who’s calling?” And you say who you are, and then they look you up on a list, see if you’re one of the admitted ones. And then depending on what that listing shows, tells them, you really get through, or you get asked to submit your questions in writing.

Kathryn Foxhall: You communicate by email because you have to. That’s the only way they will really answer you. Is that correct?

Jim Dickinson: That’s right.

Kathryn Foxhall: So, you just do it all the time. I mean, you don’t even give it a shot anymore, about getting on the phone.

Jim Dickinson: We don’t get to the original expert source in FDA. We never get to talk to them. Ever.

What’s Happening After a Reporter Goes to FDA

Kathryn Foxhall: What do you think is happening when you send in whatever it is – questions or whatever – to the FDA offices and they can take whatever time they want to take. What is happening there, behind closed doors?

Jim Dickinson: I think they determine whether this is worth the agency’s time doing anything with it in the first place. If they think it is worth the agency’s time, the expenditure of taxpayer dollars on pursuing for you, then they will go to a source of their choice. It might not be the one you want. It would be somebody that they think is better from the agency’s point of view. For instance, if I wanted to ask Janet Woodcock [FDA’s former Principal Deputy Commissioner, who retired this year] about something that she said at a meeting that we were covering, then I would have to go to the PIO and say I want to talk to Janet Woodcock about what she said. And they would want to know exactly what it was I wanted to ask Janet Woodcock. And this is my suspicion: I have no documentary, established verification of this. But my suspicion is that they: A: They either know somebody who assists Janet Woodcock on these kinds of issues and they go to them. Or they already know from some source on this particular topic and they regurgitate it back to me in an email. The chances of me actually getting my question through to Janet Woodcock, for her personal attention and her personal answer is pretty remote.

Kathryn Foxhall: So that you would be able to talk to her and maybe do a follow-up question and quote her directly – it’s just is not going to happen.

Jim Dickinson: Well, there’s two ways you could approach that. One you’ve got one question that arose out of what she told the meeting this afternoon, which can be fairly simply dealt with, probably by other people besides Janet Woodcock, in the opinion of the PIO. And the other possibility is that you have a list of questions you want to put to Janet Woodcock that were spurred in your mind by what she said…. and you are requesting an interview with those questions. And that is when the PIO will dig their feet in and say, “What sort of questions exactly? Can you give me an idea what they are?”

Now, I’ve done this before, and I know it doesn’t work: [I might say], “Well, some of them are questions that would be better expressed after I’d heard her answer to the first question.” In other words, I need to have a conversation.

….

And you’ll never get it.

What About the Lower-Level People?

Kathryn Foxhall: And I guess one excuse [the agency might give] there is that Janet Woodcock is busy. But could you, if you so wanted, talk to anybody in that office, or someone you knew is not all THAT busy. Just someone who maybe spoke at a meeting or whatever. But…they have expertise in a particular area. And they’re not like Janet Woodcock. They’re not being targeted by the press everyday. Could you talk to them?

Jim Dickinson: I haven’t tried to, lately. I’ve been so, frankly, discouraged that I don’t. It’s unlikely that such a person would come under notice. The lower-level people you’re referring to generally are speaking off a script. And the PIO’s job is to hold you to the script. And they’ll be happy to send you a copy of it by email. But as for you asking free-ranging questions based on what this lower-level person said, they get nervous. They don’t know that this lower-level person really can be trusted to stick to the party line and say what has been approved in the script. Or will you, as a clever reporter, trick them into going off script and say things that maybe they should not say. So that’s the atmosphere that now exists between reporters and PIOs.

It’s an untrusting atmosphere. And it comes from the PIO side far more than the reporter’s side. The reporter, after all, is merely trying to finish the story they’re already working on. And they’re not playing games. They don’t want to play games. But the PIO, to protect the boss, to protect the agency, in their mind, has to play games. And they play these sorts of games. Reroute your question. They ignore certain parts of your question. They ignore a whole question as they want or they pick out some text that’s come out of a document that’s been previously approved on this topic. And although it doesn’t fit your question, exactly, it’ll do a good enough job of addressing the subject your question was about.

Kathryn Foxhall: Let’s set a scenario where you know what you’re doing. You have seen a document. You’ve been at a meeting. So, you know, that this particular person--not real low, but not Janet Woodcock either--this person has a focus on and knows about this area. Could you talk to him or her if you went through the PIO?

Jim Dickinson: It’s not impossible. I haven’t had the pleasure, though. They have a very, very well-worn way of deflecting such approaches.

Kathryn Foxhall: You’re saying it’s unlikely.

Jim Dickinson: It’s unlikely. Highly unlikely.

What’s It Doing to Reporting?

Kathryn Foxhall: What do you think that it’s doing to reporting about FDA across the board?

Jim Dickinson: It’s dumbing it down. Reporters, I don’t know many of the current world-level reporters but reporters...generic journalists don’t find FDA a very interesting subject in the first place. And in the second place, they don’t have the kind of technological understanding of the issues, technological or legal understanding of the issues that FDA deals with every day. It takes a lot of experience on a reporter’s part to learn those technological and legal, regulatory type issues and to become proficient. And the more proficient you are, the more you begin to outstrip the PIO in the level of knowledge that’s being discussed, and the more wary they become of you….

I have been reporting FDA since 1974. And I know so much about the way the agency works, although my information may not be as current as it used to be. I have a reputation with some of the old timers there that maybe they don’t want to hassle with me. They’ve got better things to do. And they would rather deal with reporters who know less and who will more readily accept the printed handout, the script that they prepared and not give them any trouble…. I think it’s true of government generally. The less familiar the reporters are, the more easily they’re brushed aside and the more grateful they might be, to have some sort of quote, even if it’s not a high caliber quote, to put in their story and get it over with and go on to the next story. So, I think the PIO system in a nutshell has resulted in a general dumbing down of the public’s knowledge of how FDA works. And the rationale behind many of its decisions, if not all of its decisions, it’s opaque. FDA is opaque.

Kathryn Foxhall: Would you say that it’s keeping information from the general public and also from people who are more focused on this, like people in Congress. It’s simply keeping critical information from them?

Jim Dickinson: Yes. It’s not intended to have that effect, but it does have that effect.

Kathryn Foxhall: Well, okay, when you say it’s not intended to have that effect: would you say that there could be times that it is intended to have that effect?

Jim Dickinson: Certainly, certainly. You get bad actors in there. Yes.

Foxhall: Several years ago Christina Jewett, then with Kaiser Health News, poured some time into a story about a medical devices database, which FDA had and it was not telling the public about. With defects or issues or problems, they were supposed to have a public database. Well, they had a secret one and they had it for almost 20 years. She did a whole series. When it came out, it blew up. But she got that story originally because someone in that office retired and then became a whistleblower.

Jim Dickinson: That’s the way it goes.

Kathryn Foxhall: SPJ gave her an award. I think she got several other awards for it. I agree that she deserved them given the work and the talent….But none of us, the whole journalism community, stepped back and said, “My God, this went on for 20 years and we didn’t know anything about it. We give an award for people finally getting it. Also, we didn’t step back and say well, as far as we know, there could be 20 databases that we don’t know anything about.” Is that an adequate picture of where we are?

What We Don’t Get

Jim Dickinson:  Yes, I’m afraid it is. I’m afraid it is. The agency has become opaque. You’ve got no idea the number of stories that I got from people telling me just a little piece of it and another person telling me a little piece of the other side of it. And gradually over a period of time when I was talking to these people, they were, all of them, telling me stuff they had no business telling me. Their bosses would not like them telling me, but I got told. And I was able to put things together and the bosses didn’t like it. In fact, long after I had left and the system had gotten into place, [there was] a good contact of mine who was Associate Commissioner for Policy. Somebody I always called on every time I went into the building. He was retired. He told me on the phone, “Jim, he said, if they could have stopped you, they would have.” Well, they have [laughing]. Big bosses didn’t like it. They have got control fetishes. They want to control everything that is said about how they’re doing their jobs. We journalists are not in the business of giving them control. We’re just in the business of telling the truth.

Kathryn Foxhall: Let me just show you how far my thinking has gone and see if you think it’s legitimate or whatever. I also talked to Katherine Eban who wrote, “Bottle of Lies.”

She got numerous awards…and she testified before Congress. [I told her] reporters used to call whoever they wanted and often talk to them. I said sometimes staff people were nervous, but there was a sense of obligation that you answer a question from the public. She was flabbergasted...Her book was basically about how very bad the overseas inspections are.... But in total, she spent 10 years on this book.

Now, my feeling is, this is a symptom of implosion. We have to have a reporter spend 10 years on a subject matter before we really realize what is going on. And you know, if FDA implodes, what do we have? We are in this technological age—with pandemics and other things—and we are in such trouble. And if they lose their trust, we are just in deep trouble as a society.

Jim Dickinson: Well, I think we’re in deep trouble as a society on other fronts as well.

Kathryn Foxhall: Certainly.

Editor’s note: For a view on what happened in the Centers for Disease Control and Prevention as the controls tightened see the interview with a former CDC communications director.