Kai Peters, a partner in the Drug and Medical Device and Life Sciences practice groups of Gordon & Rees, authored “Lessons from GlaxoSmithKline’s $3 billion settlement in the US” published in the August 2012 issue of Scrip Regulatory Affairs, a leading source of global news, comment and analysis of regulation in the pharmaceutical and medical devices industries.
In his article, Kai explains the allegations against GSK which include off-label promotion, introducing misbranded drugs, and failing to report safety data, analyzes GSK’s recent settlement with the U.S. government, and provides suggestions on how pharmaceutical companies might avoid similar prosecutions, such as:
Avoid providing only favorable articles that purport to support the use of a drug for off-label uses
Avoid providing certain perks when they coincide with events at which off-label information is being discussed
Monitor the anticipated FDA guidance documents about scientific exchanges, so that companies can provide information regarding off-label uses in a permissible matter
Have procedures in place to update the labeling for approved drugs in a timely manner.
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