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Responding to criticism that FDA enforcement activities have become sluggish, officials at the agency released new statistics that suggest far more aggressive policing by the FDA over the past 4 years. Both civil and criminal enforcement activity is on the rise, and agency officials said that the new statistics reveal a pattern of ?dramatically increased enforcement, particularly in areas related to the most serious threats to public health.?
Since 1998, the number of recalls ordered by the FDA rose by 42%, injunctions climbed by 36%, arrests rose by 14%, and convictions for violation of the nation?s drug laws jumped by 60%. ?The FDA?s most decisive actions, those that remove products from the market and that bring criminal charges against people who would harm the public, have increased the most,? officials said.
The more aggressive enforcement effort has generated a string of unprecedented penalties against pharmaceutical firms charged with federal drug violations. The most recent of these penalties include the following:
? An $879-million settlement for conspiracy to commit violations of the Prescription Drug Marketing Act (TAP Pharmaceuticals, October 2001)
? $500 million for failure to comply with Good Manufacturing Practices (Schering-Plough, May 2002)
? A $355-million settlement for health care fraud (AstraZeneca Pharmaceuticals, June 2003)
? $33.1 million in fines and forfeitures for submitting false information to the FDA (Aventis Pharmaceuticals, October 2001) ? $30 million for failure to comply with Good Manufacturing Practices (Wyeth-Ayerst Pharmaceuticals, October 2000).