The investigation is focusing on whether manufacturers of the drugs, which are known as opioids, overstated their benefits and understated their risks, such as the chances that a patient could become addicted to the drugs, a court filing shows.
The drama of the story writes itself, and it would benefit from understated direction and acting that would allow the intricacies of the court case shine through.
The corps has also been consistently criticized for overstating benefits and understating costs.
"We will not be afraid to go to court when necessary" to stop companies from exaggerating the benefits or understating the risks of drugs, he said.
The F.D.A. first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug's benefits while understating its risks.
But the Government Accountability Office, an investigative arm of Congress, found that the corps's studies of proposed projects were "fraught with errors, mistakes and miscalculations" that tended to overstate the benefits and understate the costs.
In a March 2000 letter to the F.D.A., he said Avandia might raise patients' risk of heart attacks, and he criticized the company's marketing, saying it employed "blatant selective manipulation of data" to overstate the drug's benefits and understate its risks.
Woloshin also bemoaned the limited state of regulatory oversight, "which is a big problem, since companies have an interest in selling their products so you would expect they would overstate their benefits and understate their risks". Even as marketing efforts have expanded, the FDA issued fewer violation letters to companies engaged in misleading or illegal promotional efforts.
Advocates for increased regulation have long argued that cost-benefit analysis understates both the value of life and the benefits of government oversight.
The articles published on Tuesday charge that researchers with financial ties to Medtronic overstated Infuse's benefits and vastly understated its risks by claiming there were none.
