Tuesday, June 20, 2006

Ketek (Antibiotic): Senator says FDA Not Cooperating

As you read the Court decisions regarding preemption, many of the judges address the level of FDA review/involvement in the drug or medical product approval process in their analysis. Take a read of the Reigel decision (addressing a medical device and preemption of state law claims). Last week, however, Sen. Grassley tore the FDA a new one regarding Ketek.

Reports suggest the FDA may be trying to hide information about its review of a Sanofi-Aventis antibiotic known as Ketek that is linked to liver damage in some users.

From Reuters, you can read that "I smell a cover-up," Senate Finance Committee Chairman Charles Grassley said after the FDA failed to make available one of its criminal investigators for questions about his probe of fraud in a study of the drug, Ketek.

The Committee started a review of the FDA's approval of the antibiotic and subsequent monitoring of the drug's safety earlier this year.

Ketek was approved by the FDA approval in April 2004 to treat respiratory infections in adults, after the FDA twice rejected it for lacking safety information.

Several reports allege that some doctors in a Ketek study falsified data or did not keep proper records. One physician was jailed for fraud.