FDA Needs to Examine Its Institutional Culture

Posted by mfontanazza on December 19, 2011

A tendency to close ranks when challenged has kept the agency from making needed changes.

The institutional culture at FDA has been gingerly discussed (if at all) for decades. As a major election year gets

underway, the agency and its regulated industries may be forced to confront questions about how FDA does business. “There needs to be more discussion between the regulatory agencies and the industry,” said Senator Al Franken (D-MN, as quoted by the Minneapolis Star Tribune while speaking to Medtronic employees in November. He discussed legislation that would speed the approval process for devices meant to treat rare diseases. “There is a real difference in the culture,” Franken said.

To invoke another societal analogy, the Occupy Wall Street movement, it should be remembered that FDA’s cultural problems adversely effect only about 1% of its constituent relationships; the agency operates as it should 99% of the time. Of course, the problems should still be fixed.

Few in industry seem to understand the FDA culture, which in many respects is like that of any other institution prone to dysfunction. Those in a position to make changes are blindly loyal to the organization. The inevitable consequence of that loyalty is that when problems arise, the tendency of the leadership will be to cover up those problems or deny that they exist rather than attempt to solve them. 

In FDA’s case, upper management has had a “circle the wagons” reflex for years. This has repeatedly enabled mis-guided or ill-informed elements in the lower ranks to hurt small businesses. Initial erroneous or destructive decisions are automatically endorsed and defended at each successively higher level when challenged.

Take the case of Utah Medical Products. Ill-trained and poorly supervised FDA employees tried to shut the company down before ultimately being overruled by a federal judge in 2005. Though the courts spared the firm, the decision, which agency lawyers continue to privately call “aberrational,” did not fix the broader issue of cultural dysfunction at FDA.

Or consider the case of TMJ Implants. Agency employees’ anonymous interpretations of the law subsumed legitimate scientific questions, blocking approval or clearance of the company’s key product. The company tried to fight back but was twice defeated in federal court and filed for bankruptcy in 2010. At numerous points in its five-year run, the dispute could have taken a different course, but FDA’s cultural dysfunction kept things on a steady downhill trajectory.

The agency covered up the fact that it had “lost” the company’s written request for appeal for eight months. It lied about substantively reviewing the appeal before denying it, and ambushed the firm with civil money penalties before it even received the appeal denial letter. FDA administrative law judge Daniel Davidson rubber-stamped the agency’s conduct and deceit, as did the HHS departmental appeals board upon reviewing the case. This administrative record was then rubber-stamped by the courts.

Neither company’s complaints about FDA’s culture or conduct were ever reviewed by any member of the judiciary. In both cases, the commissioner in power at the time (Lester Crawford in Utah Medical’s case and Andrew von Eschenbach in TMJ’s) personally promised fixes that never came. Both companies complained vigorously (Utah Medical even sued) but both ran out of money to fund their efforts in court. Both say they didn’t find CDRH’s ombudsman to be of much help.
The record is littered with examples of FDA’s culture negatively affecting small medical device companies. In all of these cases, evidence of the agency’s misconduct remained hidden, thanks to the agency’s efforts as well as companies’ reluctance to face the consequences seeing the fight through.

FDA‘s dysfunction affects internal relationships as well. It is rumored that employee complaints of supervisor favorit-ism, misconduct, and illegal discrimination have been ignored, enabling such destructive behavior to continue without relief.
I am aware that it is not possible for anything meaningful to happen in a courtroom (or the court of public opinion) without hard evidence that those allegations are true. But for a variety of reasons—chiefly the fear of consequences among the aggrieved—such evidence is hard to come by.

Enter the media, which can shine the public spotlight on the kinds of murky details that do not meet the standards of the courtroom. Journalists have yet to do this on a broad level when it comes to the problems companies report having with FDA, but they must do so for things to change. Institutions tend not to be automatically self-cleansing; they need to be prodded, in public. As long as the culture at FDA remains undisturbed, so too will the news media’s attention—newly hamstrung by HHS access restrictions—be integral to any remedy.

The access restrictions, which have been slowly infiltrating communications between the media and FDA on an infor-mal basis since 1997, were formally put into place in October with the issuance of HHS-wide guidelines. These guidelines restrict all media communications to each HHS agency’s press office, obviously hampering the confidential information gathering that penetration of management cover-ups would require.

FDA’s “transparency initiative” has fallen far short of President Obama’s promises to produce “the most open government in history.” If anything, the agency has become more secretive, interpreting “transparency” as improved Web access to the materials it elects to make public, doubtless with some prodding from user fee–paying industry.
As is true elsewhere, institutional culture awaits change; it does not seek it out. In FDA’s case, change is something that is likely to be fought tooth and nail.

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