Pharma 101 - Pharmaceutical Fraud

Archive for July, 2006

Drug scandal allegedly reveals pattern of scientific fraud at the FDA

Phase III  clinical trials are not necessarily scientifically valid. Misreporting data or its significance  is emerging as a reality. Drugs that have become FDA-approved based upon fraud in the NDA process may be the subject of False claims Act liability. For more information, see this News Target article.

Guess What Else is NOT a Top Priority of the FDA?

Answer: Monitoring postmarketing study commitments. 

The FDA lacks an effective system for monitoring postmarketing study commitments.  See the latest OIG Report, dated June 2006. 

The Decline In FDA Enforcement Activity

Congressman Waxman’s United States House of Representatives Committee on Government Reform issued a report entitled “Prescription for Harm/The Decline in FDA Enforcement Activity” in June 2006. Enforcement is down and our FDA-related filings are up. Any relationship?