Prempro

In 2005, the proposed usage fee was $382 million or 20 percent of the FDA's total budget.

It is shortsighted to believe that a government agency can make objective decisions on the use and safety of a prescription drug when the result could translate into the loss of millions of dollars from its annual budget.

- SPOIL SYSTEM: A modern day "spoil system" exists whereby FDA officials court the favor of drug company lobbyists and officials in the hope of trading the government's general schedule for the far more lucrative and lavish lifestyle provided by pharmaceutical companies.

- RUBBERSTAMPING: Recently, there have been several instances in which the normal approval process has been ignored or significantly altered in order to rush a drug to market-with disastrous results for the user.

Yet most of these drugs remain on the marke...

The Food and Drug Administration later required warnings to be added to the drugs and advised women to consult their doctors about whether they should continue treatment.

The drugs have been marketed for long-term use since the 1940s and the suit claims Wyeth has "vigorously promoted" hormone therapy medications by sponsoring medical journal articles, having sales representatives call doctors, advertising directly to patients and hiring doctors to push their products to other physicians.

The companies failed to warn doctors and patients that the medications could contribute to the risk of breast cancer and used "aggressive" marketing campaigns that misrepresented potential side effects and safety concerns, the suit alleges.

"By the late 1990s and early in 2000, defendants knew about studies showing a significantly increased risk of breast cancer for women using combination hormone therapy," the suit states.

"Defendants' representations were false and misleading and were intended to downplay the cancer risks associated with hormone ...