It is not often that you hear trenchant criticism of an organisation from one of its senior staff.
Yet, this is precisely what Dr David J Graham, associate director of the Food and Drug Administration Office of Drug Safety, offered last November.
He said the FDA, supposedly the most powerful and influential regulatory body on health in the world, "was incapable of protecting America" against dangerous drugs. He alleged that those inside the federal agency who had reviewed the safety of Vioxx "did a terrible job".
He said that a number of other, currently available drugs had unresolved safety issues.
And he called for a complete overhaul of the way the agency reviews the safety of marketed drugs.
Unsurprisingly, the comments produced a swift response.
Dr Steven Galson, director of the agency's Centre for Drug Evaluation and Research, described some of Dr Graham's conclusions as "irresponsible" and the product of "junk science".
It is not the first time that Dr Graham has spoken out. He has worked for 20 years in the office for Drug Safety, whose function is to monitor reports of adverse events in medicines already on the market.
On many occasions he has questioned the FDA's approach to drug safety. He does not share the view of others within the organisation and some pharmaceutical executives that the FDA's primary role is to make sure that doctors and patients understand the risks of the drugs they take.
Once the risks have been disclosed, it's up to doctors and patients to decide whether to prescribe and use an individual medication.
From Graham's perspective however, people must be protected not only from their own poor choices but from those of their doctors as well.
His actions have precipitated an intense debate about the relationship between the FDA and the pharmaceutical industry.
Is the agency too close to an industry it is supposed to supervise?
Has the FDA become a client of big pharma?
The Vioxx controversy has triggered a congressional investigation and proposals for reforming the FDA.
One of the key issues up for review is a decision made 12 years by the White House and Congress.
The Prescription Drug Fee User Act created a system by which drug companies pay the FDA a fee for each medicine put forward for review. In return, the companies are guaranteed a swift decision on approval.
(Additional reporting: Financial Times Service)