Out of the U.S. No Oversight Necessary?
Today the OIG posted "Challenges to FDA's Ability To Monitor and Inspect Foreign Clinical Trials" (OEI-01-08-00510). As all new investigational drugs and biologics must undergo…
Read More »Pharma 101 – Pharmaceutical Fraud
Pharmaceutical Fraud News & Insight form the Qui Tam and False Claims Act Perspective
Contact FormTag Archives: FDA
Pfizer to Pay $2.3 Billion in Largest Healthcare Fraud Settlement in Government’s History
Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion to resolve criminal and civil liability arising from the…
Read More »Quality Control Violation Reports Prompt Drug Maker Mylan to Halt Production, Launch Probe
While Mylan has not publically acknowledged serious problems at its generic drug manufacturing facility, the Pittsburgh Post-Gazette has obtained internal reports alleging that employees at…
Read More »Effect on Off-Label Marketing in the 2010 Budget Details?
The Department of Health and Human Services recently released its budget proposal for 2010. As it relates to the FDA, HHS is looking to build…
Read More »Senator Requests Clarification of Recent Memo to FDA Employees
U.S. Sen. Chuck Grassley wrote a letter on March 24, 2009 to FDA's acting commissioner asking for clarification of a recent memo to FDA employees,…
Read More »Allegations of Pharmaceutical Fraud Lands Forest Labs in Hot Water
The Department of Justice has filed a civil complaint against Forest Laboratories alleging that the pharmaceutical company intentionally concealed a clinical study containing negative results…
Read More »CRO’s Conflict of Interest
St. Petersburg Reporter Chris Hundley wrote (July 1, 2007) a well-written, balanced and comprehensive (as can get in an article) about Contract Research Organizations (CRO’s). …
Read More »FDA Launches Draft Guidelines On Financial Ties With Drug Companies
If an outside expert has more than $50,000 in ties to drug and medical device companies regulated by the Food and Drug Administration he will…
Read More »Unapproved devices hit the FDA Radar Screen
The FDA recently announced that it had filed for a permanent injunction against Endotec Inc. of Orlando, Florida to stop the illegal distribution of unapproved…
Read More »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.
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