By: James G. Dickinson
This public comment on the May 2010 document entitled FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration is submitted to the Docket by James G. Dickinson, editor of Dickinson’s FDA Webview and FDA Review, and Washington correspondent for Medical Device & Diagnostic Industry magazine and Medical Marketing & Media magazine. I have been reporting on FDA affairs for a wide variety of specialized media since 1975.
While I commend the FDA Transparency Initiative and endorse all of the draft recommendations in its latest report, I am deeply disappointed in the Task Force’s failure to recommend substantive, necessary and overdue reforms in FDA’s unwritten and oppressive media access policy.
It is my observation that today’s FDA shares with the rest of government a cover-your-ass bias against informing the public. The Task Force unsurprisingly has no public representation in its membership, in apparent continuing service to the antithetical ways in which government and the news media handle public information. For government, the dissemination of information to the public must first be evaluated for risk-benefit — the good should outweigh the potential bad; this evaluation process usually is slow. For the news media, public information is a First Amendment-protected end in itself, only extremely rarely (e.g., national security) to be qualitatively evaluated before information dissemination occurs; consequently dissemination is fast.
FDA’s amenability to disclosing information about itself and its daily work is extremely poor, and much worse than it was before 1996. Information supplied on request by the FDA Press Office is routinely skimpy and less than needed, frequently requiring multiple and time-wasting follow-up prods to elicit more. The process can consume many days or even weeks; I have a request about the FDA-DoD LASIK outcomes study that has not been answered since March, despite many prods on my part. It is like squeezing blood out of a stone. This may be a consequence of the under-staffing of the Press Office. It is certainly the consequence of a dense system where the inquiring reporter’s needs are less fully met through an intermediary than they would be without one.
Ironically, the Task Force’s report is prefaced with a quote from former Commissioner Donald Kennedy, which correctly says that a basic principle of our political system is that “people affected by governmental decisions have a right to know the basis on which they are made. Anyone who questions the wisdom of a regulatory decision should be able to examine the factual foundation of the decision.” FDA has not met this standard in establishing its unwritten media access policy without any notice to affected parties.
Members of the FDA press officer corps have sometimes commented to me that my complaints about restricted access aren’t commonly made by other reporters. I attribute this to several recent phenomena: (1) The youth of many current reporters who can’t remember days of better access to this and other agencies and therefore have no point of comparison; (2) an involuntary, defensive instinct to not offend the hand that feeds them; and (3) intimidation from employers that may have policies (e.g., New York Times) that prohibit joining group actions that might affect their work.
As Felice J. Freyer, chair of the Right to Know Committee, said recently in encouraging media organizations to publish the fact that a quoted interview was monitored: “Reporters have come to accept the presence of public relations people at interviews, but it’s really not acceptable. We all know that such eavesdropping hinders the free flow of information — and we need to let our readers know that this is happening.” To the extent that publications follow this advice, the reading public will come to know that government, not the free press, is controlling public information, and that the First Amendment is being routinely violated by the U.S. Government in a secret policy.
Confining reporters’ access to the single portal of the FDA Press Office where inquiries can be manipulated, parsed, monitored, eavesdropped, tracked and trafficked opens enormous opportunity for political and other improper filtration/censorship of information — and consequent further erosion of public trust in FDA.
In the Media Policy chapter beginning on Page 61 of the Task Force report issued in May, the Task Force acknowledges that “some members of the media stated that FDA’s current procedures for dealing with the media restricted the flow of information between the public and FDA personnel. These comments stated that public affairs officials can play an important role answering questions and facilitating interviews, ‘[b]ut when they forbid, delay or monitor contact between reporters and employees, they interfere with the public’s right to know and can delay access to timely information necessary to protect and advance public health.’”
This chapter goes on to acknowledge that “comments stated that prior administrations allowed more communication between FDA employees and the media and that FDA’s practice is not universal among federal agencies.” Typical of FDA lawyer-massaged official responses, the chapter offers no Task Force reaction to these acknowledged criticisms, and instead records comments received at a 4/12/10 conference call with representatives from the Association of Health Care Journalists and the Society of Environmental Journalists to follow-up on the comments they had previously submitted to the Task Force.
The Media Policy chapter says that “Given FDA’s regulatory authority and responsibility, it is very important that FDA provide information to the news media as promptly and accurately as possible. Like many other public agencies, FDA has a public affairs office to facilitate and coordinate requests from the media. On average, the public affairs office fields between 50 and 100 inquiries from journalists every day.”
The chapter goes on to venture, chillingly, that “FDA personnel may establish a record of what is discussed to improve their own understanding of issues and to identify additional information of relevance that can be shared with the journalists,” before adding, even more menacingly, that the agency “plans to track and disclose measures of performance related to its interactions with the media and will start by tracking the number of press inquiries received each month. FDA will also draft a policy outlining FDA’s media process and post this policy on its Web site. FDA will continue to explore additional ways to make the agency’s system as effective as possible.”
In other words, FDA wants to “improve its own understanding of the issues” by tape-recording reporters’ conversations with employees when it is highly unlikely that FDA does not already know more about those FDA issues than the reporters know. If these words mean that FDA wants to make the recording of the interview so that it can disseminate it internally for staff-training and educational purposes involving the interviewing reporter’s factual information revealed in his/her questions, this would ethically require the reporter’s prior consent, as well as that of his/her publication.
Even worse, this sentence reveals an agency intention “to identify additional information of relevance that can be shared with the journalists.” Clearly this could only occur after the conclusion of the recorded interview, and would necessarily be a separate response of “sharing” sequelae of the interview “with the journalists.” Since interviews are typically conducted by a single journalist, who are the others? The results of FDA’s unrequested further action to “identify additional information” for “sharing” purposes could therefore be made available by the agency to other journalists, who likely could be competitors of the original journalist, thereby disadvantaging him/her and the publication involved.
Unaddressed by this sentence is the ownership of the “additional information” gratuitously identified by FDA from the recording made of the interview and “shared with the journalists” (plural). Ethically, at least, it should be owned by the original interviewing journalist and his/her publication and not shared by the agency with anyone else, at least until after publication.
In addition to revealing that the present policy on media access is an unadmitted strategy to control the conduct of media communications with FDA employees by formalizing all of them into structured and monitored interviews, this chapter of the Task Force report reveals an intent to misappropriate the recorded content of such interviews for internal FDA purposes. The ownership of the informational content and rights to its further usage is left unaddressed.
Further, this chapter reveals that the agency wants to track media inquiries as a means of better controlling its dissemination of information to the public. Such tracking is by definition contrary to the intent of the First Amendment, which on its face clearly contemplates that the government will not abridge the freedom of the press. Being “tracked” as well as involuntarily recorded or monitored is inconsistent with the meaning of “freedom” (Merriam Webster’s Collegiate Dictionary (1993): “ … absence of necessity, coercion, or constraint in choice of action … state of being exempt or released … unrestricted use … etc.”).
Glaringly, this chapter ignores informal, off-the-record communications between the news media and agency employees that are unsuitable for the “interview” construct. The absence of any allowance for these kinds of interchanges, which often involve “whistle-blower” quality disclosures uncomfortable to management, clearly abridges both the free speech and free press guarantees of the First Amendment. Clearly, “tracking” such interchanges would defeat their purposes completely.
Recently I became aware of an HHS Press Office “template” of media screening questions which I believe are intended to be used by press officers generally in screening interview requests. These questions as worded seem to have the intrusive purpose of evaluating the appropriateness for agency purposes of the media represented as well as the reporter making the request — in other words, they are part of an initial qualifying exam to aid the agency in deciding whether to allow the interview to occur, and to decide which employee is best qualified from the agency’s perspective to participate in the interview. This is an objectionable and unconstitutional control over the conduct and content of the interview.
Will you be taping?
Will you be quoting?
Are you interviewing other sources?
Can you provide the article/quote review prior to publication?
What is the article word count?
When will the article publish?
Can you provide a background on your publication?
Can you provide us article samples that you have written?
Also, what is your deadline?
Whether the free press elects to use a tape recorder, or chooses to quote or not quote, or interviews other sources is not government business; the presence of such questions in a screening template is an attempt to intimidate and assert an improper control over a reporter’s exercise of a First Amendment-protected privilege. Other questions reflect both government ignorance — article word counts are seldom known in advance — and intrusive efforts to evaluate the worth of the requested interview to FDA. In short, with the exception of the deadline question, all the screening questions are coercive media control mechanisms intended to demonstrate to the reporter that FDA is in charge of the interview.
Finally, the Media Policy chapter’s last sentence vows to make the present system “as effective as possible.” This is an implicit denial of the affected media’s formal requests to the Task Force that the system be replaced with a system that allows direct access to confidential information sources within FDA. Since this issue has apparently already been decided but without any detailed explanations or opportunity for media interests to know why, the submission of this comment by me to the Task Force docket would appear itself to be futile.
Notwithstanding vigorous protests about the present policy — which has been in force for more than 12 years without any written justification or due-process prior notification to affected media for their input — from 11 major journalism groups, including the nation’s largest, the Society of Professional Journalists, the Media Policy chapter makes it seem that the Task Force already sees no need for substantive change.
That change is both necessary and long overdue can be demonstrated by the secrecy of FDA Press Office personnel movements, including the comings and goings of Press Officers assigned to program categories. The Office’s Web page was not updated between 2/23/10 and June when a critical report on my Web site pointed this deficiency out, whereupon a backdated 4/29/10 update was posted, revealing a massive turnover in staffing assignments, each of which should have been announced immediately to all media representatives doing business with that office.
My inquiries as to the mysterious recent assignment of Assistant Commissioner for Public Affairs George Strait to “special projects” as Associate Commissioner for External Affairs Beth Martino reportedly took over were ignored. Apparently, personnel movements within FDA are now regarded as being none of the news media’s business, although they were formerly a staple of trade press news coverage in the days of greater FDA transparency and accessibility (pre-1996). This is another indicator of FDA efforts to control and define what is allowable news about its operations.
If all this sounds a bit like George Orwell’s 1984 or the tactics employed by secretive totalitarian regimes, I think so, too. One former senior FDAer even called the Transparency Task Force report “a ‘cover-up’ to continue protecting their fiefdom at the risk of public safety.” At the very least, it conjures up images of “Fortress FDA” manifesting an “us-versus-them” barricaded mentality protecting the “FDA family” from outside intrusiveness by the news media.
There have been several complaints on my Web site by FDA employees about inaccuracy and misreporting by members of the news media, and undoubtedly these are true. Just as any organization or field of human activity has its share of bad actors, so, too, do the news media. In the Orwellian world of government accountability to the public and their news media, a principal excuse for sealing an agency from free press access is that employees value their protection from errant reporters.
In the real world, however, those outside government service somehow learn to get through life alongside such irritants — the rude postal clerk, the unknowledgeable sales associate, the aggressive policeman or neglectful receptionist. Instead of being shielded from all reporters, good and bad, as FDA employees are now, in the private sector employees instead exercise their right to complain in the appropriate quarters about abusive, negligent or incompetent treatment they have encountered in a variety of work settings. Their complaints then might become part of the offending individual’s on-the-job training to become a better policeman, postal clerk or receptionist — or journalist. Most news organizations correct their factual errors, some better than others.
For my part, I proudly correct all errors reported to me — and I have been known to publicly apologize in a bold way. As my mentor in this business, the late, great Wallace Werble Sr. (founder of the Pink Sheet) used to boast: “I eat the best crow in town!” It always hurts, but I still try to follow that example. And I should point out that for its part, FDA has never done a comparable public confession of error, much less issue a public apology. There may be a double standard here.
Possibly the most serious deficiency in the present media access policy is that it gives excessive and stifling control over the news media to the Press Office and through it to agency management. For example, it completely prevents the media’s traditional role of being the “fly on the wall” watching (and reporting) the interactions between the agency and congressional overseers. Before 1996, this was the norm. Physical journalistic legwork in the corridors of FDA, observing and listening, is no longer possible — but an electronic equivalent through emails is surely possible and should be allowed within enlightened and legally required bounds that preserve the confidentiality and trust of FDA informants. At the very least, senior FDA managers should hold weekly, free-for-all news conferences.
The benefits of this would be more transparency as well as restored public accountability on the part of FDA personnel in a modernized system that protects, as FDA has always protected, information that it is required to protect, while returning to the public arena information that the agency is not required to protect but which it hides out of doubt, fear of consequences, or other extra-legal considerations.