FDA staffers vent to President

Check out this story about whistle blowing from inside FDA.  Thanks to a tip from PharmaGossip, we've learned of a letter sent by FDA insiders to President Obama on April 2, 2009. You can read the full text of the letter here. The letter was well timed to coincide with the appointment of the FDA's new commisioner, Dr. Margaret Hamburg, who many hope will inaugurate a new era of transparency and accountability at the agency.

The FDA staffers complain of a growing sense of frustration with the 'arbitrary and capricious' decision making at the upper echelons of FDA:

The latest example of wrongdoing was reported on March 23, 2009 from a Federal District Court Judge who ruled that FDA’s decision on the Plan B drug was “arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” FDA’s top leaders at the Center for Drug Evaluation and Research (CDER) testified that they “didn’t have a choice, and . . . [weren’t] sure that [they] would be allowed to remain [in their positions if they] didn’t agree” to ignore the science and the law. To the contrary, they should be removed from their positions of authority precisely because they didn’t follow the science and the law. The judge further ruled that there was “unrebutted evidence that the FDA’s [decision] stemmed from political pressure rather than permissible health and safety concerns.” The “improper political influence” and the many “departures from its own policies” reveal that such FDA officials are incapable of ensuring integrity
and science at FDA.

They go on to report concern with the agency's culture of wrongdoing and coverup, saying 'FDA is fundamentally broken':

On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta: “Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around. Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. … America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re- establishing a proper and effectively functioning FDA is vital to the physical and economic health of the nation.”

It's unclear from my vantage point how many of these accusations are merited. But it's certain that at least some FDA employees (names blacked out in the letter, but judging from the size of the text block, appears to be 5-10 individuals) have honest concerns about the agency's current culture and future directions. We're hopeful that the coming weeks will shed more evidence about the mistakes that have been made, and how Dr. Hamburg intends to reinvent FDA with a commitment to institutional integrity.