FDA Allows Drug Companies to Understate Risks from Drugs
- (Reuters) - Consumer watchdog Public Citizen has called on U.S. health regulators to withdraw a proposal that would allow pharmaceutical companies to distribute medical literature suggesting a drug's risk is less than stated on the label.
In a letter released on Wednesday, the organization urged Health and Human Services Secretary Sylvia Burwell to withdraw the proposal, saying pharmaceutical companies could "sell more drugs by making them seem safer than FDA has judged them to be."
Last June the Food and Drug Administration proposed allowing the distribution of new risk information about approved drugs, saying that a drug's safety profile "evolves" as exposure to the product increases.
The FDA said it would allow distribution of new information in medical journals showing that the severity or frequency of a side effect is lower than described on the product label. The new data could even "call into question a causal relationship between a drug and an event in the approved labeling."
Companies would not be allowed to distribute literature about newly identified risks or information that shows an already identified risk is more serious than stated on the label. Such information would need to be reviewed by the FDA and potentially included in the label.
The proposal, critics say, would strip all meaning from current laws requiring FDA approval of a drug's label, which includes its risks, benefits and other prescribing information.