Reprinted with permission from fdaweb.com
10/05/2009

[Analysis by Jim Dickinson*] Forget “open government,” especially at FDA. As the Obama administration visibly wilts under national security objections to a reporter’s shield law and resists a federal judge’s order that it release an FBI interview with former vice president Dick Cheney about who “outed” secret agent Valerie Plame, other less-visible wilting is undermining its transparency ambitions at one of the most secretive agencies of all — FDA.

Since the Reagan Revolution, concealing and withholding information has been infused into FDA’s virtual DNA by successions of conservative appointees, none more effectively than Bush chief counsel Dan Troy, who famously kept no records of his meetings with outside parties — all the better for deflecting Freedom of Information Act (FOIA) requests.

Defying the spirit of Obama first-days-in office Executive Orders and Attorney General memos that all agencies err on the side of disclosure when asked for internal documents — thus reversing equivalent Bush Administration directives — FDA is so far clinging to its extra-legal secret ways. Its track record says it will win.

Last month, in response to a Freedom of Information Act (FOIA) request from Moms Against Mercury national counsel Charlie Brown for internal, predecisional deliberative documents leading to the 8/4 final rule on dental amalgams, FDA released a 23-megabyte file of massively redacted records, including no less than 75 pages withheld under the FOIA’s Exemption 5. That exemption states:

Privileged Interagency or Intra-Agency Memoranda or Letters. This exemption protects “inter-agency or intra-agency memorandums of letters which would not be available by law to a party …in litigation with the agency.” As such, it has been construed to “exempt those documents, and only those documents, normally privileged in the civil discovery context.”

The unredacted remnants of the agency’s disclosures in that package were, effectively and no doubt intentionally, worthless to Brown — and to anyone else who hopes for FDA openness. Specifically, the Exemption 5 excisions were false, according to well-known medical device lawyer and former FDA compliance director for medical devices Larry Pilot, who has first-hand knowledge from defeating the agency in court on this issue. He tells us that the documents requested on the completed amalgam rulemaking would be available by law in litigation with the agency, so this nondisclosure is illegal.

FDA’s new leadership will not discuss this, referring Brown and all other interested inquirers to the agency’s long dysfunctional appeals mechanism which for decades has serially found in favor of the agency through all review levels up to U.S. District Court, usually a forum that is too expensive for most protesters to engage.

At the risk of sounding like a special pleader for the anti-amalgam cause, which I am not (although I have publicly stated that the final rule is FDA’s worst in 33 years), another FDA exposition of inapposite legal excuses to avoid the issue occurred when CDRH ombudsman Les Weinstein declined to let the amalgam issue go to his Center’s Alternative Dispute Resolution Panel.

While I have the deepest respect and admiration for the majority of FDA employees who are tireless in their dedication to public health and safety, and I separate them from the exterior-insulating “culture” which dominates them, both the FOIA denial and Weinstein’s rejection are good examples of that hostile culture. Since Reagan, it has grown up under, between and over FDA’s diligent public servants to oppose daylight-seeking external constituencies’ objections to internal decision-making.

Each of the foregoing examples cited inapposite grounds, and each were consequently tacit admissions of no reliable grounds. This has become a management pattern.

Take the case of LASIK vision enhancement patients who say they were denied informed consent by their surgeons and consequently suffered disabling permanent injuries from devices that the FDAer in charge at the time now says in retrospect should not have been approved for that procedure. As thousands of eye surgeons around the country continue to violate FDA cautions issued last May, the agency says only that it will give “appropriate” review to their promotional activities and declines to say whether it will investigate ambulatory surgical facilities for compliance with Medical Device Reporting (MDR) requirements for adverse events. “FDA can neither confirm nor deny the existence of an investigation,” its press office repeatedly says.

FDA silence about its own investigations is discretionary, not required. When the public and President Obama were upset about contaminated peanut butter, the agency fell over itself to talk about its diligent investigations into Peanut Corporation of America. Beyond the limelight, however, small enforcement matters that millions don’t care about are routinely hidden because the agency’s culture is more comfortable with not having to explain itself.

Yet another example of this, still pending before the U.S. Court of Appeals for the Tenth Circuit, involves civil money penalties assessed by FDA against TMJ Implants Inc. for not submitting 17 disputed MDRs. In this long-running dispute, Weinstein’s office failed miserably, as did all internal appeal levels including FDA’s geriatric and dependent administrative law judge, Daniel Davidson, and the HHS Departmental Appeals Board. The company simply wanted FDA to explain scientifically why the 17 incidents required MDRs, and all FDA could do was recite CFR passages.

Four years ago, we asked our thousands of readers to tell us if they knew of a case in which FDA had reversed a decision it had made. Nobody responded, inviting us to draw the conclusion that the agency never has changed its mind. This conclusion agrees with the uniform experience we’ve had over the years whenever we have appealed an FOIA denial and also agrees with infrequent but high-profile cases of companies that have tried to persuade the agency that it interpreted inspection findings or product submission data incorrectly.

The net effect of all of the above experiences plus many others over 20-plus years has been to strengthen the FDA bureaucracy’s culture of effective immunization against external criticism and protest. “Commissioners come and commissioners go,” gloated one long-time FDA compliance branch chief when I mentioned former commissioner Arthur Hull Hayes’ ongoing transition, “but we stay here.” The opportunity for such a conversation could not occur today because the access that allowed it has vanished.

The implication of the comment could not have been more memorable: down in the bowels of the agency where the day-to-day decisions are made, commissioners and their helpers don’t matter — the permanent bureaucracy runs itself in myriad personal fiefdoms, clandestine and informal laws unto themselves. Division directors have little incentive to challenge branch chief sign-offs, nor have office directors reason to up-end the sign-offs of division directors, and above the fray Center directors want to keep things moving. The higher a matter rises in the organization, the more irreversible it becomes.

The public policy line of fire floats in the remote upper echelons at the politico-bureaucrat interface. Eventually, the politico is usually captured by the bureaucracy that he/she has been sent in to tame, and becomes an advocate/apologist for the status quo.

Thus, initial low-level decisions, however flawed, effectively become final agency decisions, serially blessed as such at each level of administrative review and appeal until, if seriously questioned, they face the U.S. District Court level, where few ever venture because of the expense or loss of interest due to the time that has elapsed.

An important factor to consider when it is a regulated company that has been denied, is that company’s fear of FDA employee retaliation in its unavoidable future interactions with them — discretion easily becomes the better part of valor. Few companies with shareholder responsibilities and an acute eye to the next quarterly report are willing to engage FDA’s recalcitrant bureaucracy on a point of regulatory principle.

Ultimately, it all gets down to money. Where is the money? That is where the regulatory solution usually lies.

Forget openness at FDA. Different constituencies have different meanings for that trite word, and the new-age reformers must balance all of them against each other. Public interest activists and the news media want industry blood. Industry wants protection from those muckrakers. Injured patients want compensation. Care providers and insurance companies want the opposite. Congressional overseers want re-election. Most FDA bureaucrats want to stay under cover and do what they’ve always done.

Commendably, Obama’s principal deputy commissioner Joshua Sharfstein, a refreshingly energetic and dedicated public health aficionado with an accomplished record as Baltimore City’s health commissioner, has initiated a transparency task force project at FDA that is still gathering public input.

One thing is already apparent from this project: Every constituency has its own, and often self-serving, idea of transparency. Regulated industry, for example, tends to see FDA transparency as a quality in the agency’s closed communications with sponsors that optimally exposes evolving review issues in the most helpful way.

The news media, on the other hand, see transparency as free access to every FDA employee without having to go through the controlling filter of the FDA Press Office, which monitors all their interviews and gathers their news for them at a bureaucratic pace, expressing its findings in press office-approved words. Current controls on internal FDA newsgathering, introduced during the Bush administration, homogenize the language of FDA journalism, blurring the stylistic and often the substantive differences between competing media reports on the same FDA topic.

Previously, reporters and others who were sufficiently interested could roam FDA’s halls at will, knock on any door, gather their own news and legally accessible documents without FDA management supervision, and build their own confidential “contacts” lists comprising authoritative employees who would freely talk about their work within legal limits in exchange for effective anonymity.

Those freewheeling days are gone, shuttered by the Bush administration on both policy and convenient security grounds. Obama’s team won’t disturb that, either. “Give a press secretary power to control the press, and you think he’s going to give it up?” asks a highly respected former associate commissioner, incredulously. No matter, apparently, that the First Amendment prohibits such government power — or that conservatives and Blue Dog Democrats alike fear similar power being turned onto health care, which enjoys no such Constitutional protection.

By law, FDA is required to protect industry secrets entrusted to it in various product applications. It also has other statutory secrets to protect, including those within investigatory files against regulated entities, and intimate patient medical histories in the data supporting product applications. It also must protect its own employees’ personal information from outside probes.

Expanding upon those legitimate and minimal protections, FDA has for more than 20 years vastly over-interpreted FOIA’s exemptions and exceptions to public disclosures to the point where many today consider it among the government’s most secretive agencies. FOIA’s exemptions have consumed the spirit of the Act at the agency, a knowledgeable lawyer observes.

Where the FOIA’s exemptions and exceptions are usually permissive — that is, optional for the agency to impose or not impose — FDA’s virtual DNA compels it to opt for non-disclosure as if that is the safest default position to adopt. This is diametrically opposed to the “err on the side of disclosure” memo to all agencies from attorney general Eric Holder last March, when he cautioned: “First, an agency should not withhold information simply because it may do so legally.”

A growing us-vs.-them sentiment seems to guide FDA public communications policy. Last week, when someone inside CDRH leaked to the Wall Street Journal an internal memo written by Office of Device Evaluation director Donna-Bea Tillman, it took a full day of arm-twisting to convince FDA’s Office of Public Affairs to release that memo more generally. In pre-Bush days, prior office policy would have automatically released any leaked document on the theory it had entered the public domain.

But, in this case, the memo reflected credit on the agency, and so it was released with its author’s consent. This is FDA’s new disclosure policy, according to assistant commissioner for public affairs George Strait, whose own professional goal is unabashedly to spread the good news about FDA. Had the internal memo reflected discredit on the agency and the author had opposed its release, it probably would not have been released. After all, we’re all only human, aren’t we?

On a related issue, when we requested the official FDA memorandum of a meeting 8/31 between the agency’s high command and the medical device industry on strengthening the 510(k) review process, Strait sent an email two days later saying “we are researching” the request. Previously, memos of such meetings were routinely available from the office of the first-listed FDA participant or the agency’s Executive Secretariat.

And so the openness of former days at FDA will not return. The culture set its increasingly secretive course over 20 years ago and no amount of well-intentioned reform will change the virtual DNA that conceals and withholds.

* Editor, FDA Webview