Module 5 Presentations

05/07/2024

Ketek case - study 3014 (2)

• 2002 - The company learns of fraud in study

• 2002 - The study is submitted to FDA

• June 2002 - A routine FDA inspection of the practices of the physician who enrolled the most patients - more than 400 - uncovered fraud, including complete fabrication of patient enrollment. • The physician was sentenced to 57 months in federal prison for her actions, fined $557,251 , plus $925,774 compensation of damages to sponsor. • Inspections of nine other sites enrolling high numbers of patients revealed serious violations of trial conduct, raising substantial concerns about the overall integrity of the study.

The Organisation for Professionals in Regulatory Affairs

Ketek case -study 3014

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Ketek case - study 3014 (3)

• 4 of the 10 inspected sites were referred for criminal investigation

• FDA investigators declare study 3014 is unreliable .

but

• On April 1, 2004 Ketek is approved with all proposed indications.

2004 – Ketek launched

•

• February 2005 (7 months after the drug was introduced to the U.S.

market), the first death from Ketek - associated liver failure - in a patient treated for a mild respiratory tract infection was reported to the FDA

The Organisation for Professionals in Regulatory Affairs

Ketek case -study 3014

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