How many ways are there to criticize the FDA? How many ways are there to criticize the U.S. Food and Drug Administration? One supposes there are lots.
One might say the agency is slow and unresponsive when reviewing new drugs, devices, and other products, as many people allege. One might say FDA is lax and inconsistent in inspection and enforcement, as many people also allege.
One might say, in rebuttal, that FDA is so slow and lax because it is woefully underfunded and can't possibly be expected to do all of its important jobs correctly, as many, many people now allege.
One might say FDA is too close to the regulated industries and needs to be tougher rather than friendlier to them, as many people allege.
And one can always have a lively debate about when FDA, in its zeal to protect the public, is too much of a burden and obstacle to industry.
But one supposes that it's none too common to hear people come right out and accuse the agency's leadership of being so fundamentally corrupt that they ignore science in favor of companies, and create a hostile environment for employees who speak up about the misconduct.
And one further supposes these accusations are all the more dramatic and meaningful since they come from nine scientists within FDA's device review and approval division, the Center for Devices and Radiological Health (CDRH).
One wonders what to suppose next.
In early January, the FDA scientists wrote a letter, on CDRH letterhead, to the Obama transition team, detailing their concerns and pleading for wholesale change in the leadership and culture of FDA. If there wasn't so much else going on in the economy and internationally in the run-up to the inauguration, this story would be plastered on front pages most everywhere, but it has not been.
The scientists call FDA "fundamentally broken," and say that it has been "corrupted and distorted by current FDA managers, thereby placing the American people at risk." The letter alleges that the Director of FDA's Office of Device Evaluation "ignored the recommendations of all the experts" that had reviewed the science relating to mammography CAD devices and found it lacking, and cleared the devices for marketing anyway.
They describe scientific considerations being shunted aside by manager-level FDA personnel, who have, the letter says, "incompatible, discordant, and irrelevant scientific and clinical expertise in devices" over which they nevertheless have decision-making power, and say they have "ignored serious safety and effectiveness concerns of FDA experts." The letter even says these managers have "ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions, and recommendations."
The scientists call on the new administration to add protections for government employees who speak out against misconduct and corruption, and give expert scientists and physicians the leading roles in final regulatory decision-making, not less-qualified managers.
The corrupt managers, says the letter, should all be fired and punished. And all their improper decisions, whether involving clearance or approval of medical devices, or involving personnel actions, "must be reversed."
One supposes the Obama team will add these accusations to their list of issues to mull once they turn their attention to FDA. And, given the seriousness of the accusations, one also supposes these will be near the top of that list.
