Drug Safety News

FDA Uses Back Door to Issue New Rule Protecting Negligent Drug Companies

January 18— The Food and Drug Administration (FDA) has issued a new rule – developed behind the scenes in consultation with the drug companies and without any public comment allowed – that effectively eliminates state drug safety protections. Under the rule, a drug company that puts a dangerous drug on the market – such as Vioxx, which an FDA scientist acknowledged killed as many as 55,000 Americans – would now be immune from liability based on the drug company’s failure to warn doctors and patients of a drug’s dangers if the drug’s warning label met the new minimum federal standard.

“The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process,” said Ken Suggs, President of the American Association for Justice (AAJ). Read the full press release

U.S. Senate Passes Drug Company Giveaway Puts American Public At Risk From Dangerous and Deadly Drugs and Vaccines (Dec. 22)

News Summary: Editorial Boards Criticize Broad Liability Protections for Vaccine Makers (Dec. 21)

Background

Vioxx, Propulsid, Phen-fen... All examples of corporate executives getting rich off of drugs that they knew would kill or seriously injure patients. Between executive greed and a weak FDA, America needs lawsuits as the last line of defense against unsafe drugs.

Americans Pay More for Drugs, But Treatment Isn't Necessarily of Higher Quality (Aug 2005)

Whistleblower Dr. David Graham on the FDA (Nov 2004)

When FDA Failed… Civil Justice System Prevailed (Jan 2006)

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