Ranking Member John Shimkus of Illinois said since new legislation recently gave FDA additional power to regulate DTC advertising, it was too soon for lawmakers to intervene, “We gave the FDA power to act and we haven’t really given them time to really impose civil fines on false and misleading ads.”
Rep. John Shimkus (R-Ill.), ranking member of the Oversight and Investigations Subcommittee, however, pointed out that the FDA Amendments Act gave FDA power to impose civil fines on companies when DTC ads are false or misleading. “This provision just went into effect one month ago,” he said. “I wonder if this is the appropriate time to be debating these issues.” The ad campaigns for Vytorin, Procrit, and Lipitor aired before FDAAA, he added.