The <<>> historically sound reputation could be in jeopardy due to it's possibly too close relationship with the major pharmaceutical companies.
The FDA is the largest pharmaceutical regulator in the world and has in the past been considered tough but very fair.
The organization has always promoted strict scientific standards for drugs testing.
Now legislators and politicians have become concerned following the increased number of drug recalls and the rate of health scares involving prescription drugs, and have started inquiries into the conduct of the regulator.
That review process has rendered even more complex and drawn out because, during the inquiries, the FDA has remained leaderless.
The chink in the FDA's credibility also coincides with problems being faced by many of the big drug companies.
Many are suffering from a dearth of new products in their pipelines, with the result that they are resorting to even heavier marketing of the successful blockbusters drugs.
This media attention has seen a detrimental effect on public health, as for example, many individuals who took the now-withdrawn painkiller Vioxx did not actually need them.
The FDA has issued 58 severe safety warnings on medicines in the first nine months of this year, compared to only 26 such warnings in the same period last year and 33 black-box notices in the whole of 2004.
Most medicines carry warnings about side effects but the FDA uses a bold black border on some drugs in order to highlight side effects that it considers to be particularly serious.
Since Vioxx was withdrawn from the market in September last year amid claims that the FDA had ignored several studies reporting that the pain reliever could cause heart problems, the number of black-box warnings has increased.
During the Vioxx scandal some critics said that it demonstrated that the FDA had a greater interest in easing the regulatory burden on drug companies than in protecting public health and safety.
The agency then promised to increase its vigilance and improve its response to questions about drug safety in an attempt to dispel mounting public concern regarding the side effects of commonly prescribed drugs.