Pharma 101 - Pharmaceutical Fraud » Clinical Trials

FDA Warns Pfizer About Pediatric Trials of Geodon

Nolan and Auerbach — Mon, 26 Apr 2010 16:08:05 +0000

On April 9^th, the FDA issued a Warning Letter to Pfizer, Inc. concerning its conduct during a clinical trial for one of its prescription drugs on the market. According to a Wall Street journal article (“FDA Warns Pfizer About Pediatric Trials of Geodon,” April 21, 2010) the drug (name redacted in the Warning Letter) is Geodon, which is FDA-approved to treat schizophrenia and bipolar disorder in adults. The FDA admonished Pfizer over its failure to properly monitor the clinical trials resulting in excessive doses given to pediatric subjects. The Warning Letter reads “dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.” Geodon does not have a pediatric indication.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

FDA’s Postmarketing Studies and Clinical Trials Draft Guidance Gets Supported By Public Citizen

Nolan and Auerbach — Tue, 03 Nov 2009 02:21:02 +0000

In an October 13 letter to the FDA, the well respected consumer advocacy organization Public Citizen, gave a strong endorsement to the FDA Draft Guidance on Postmarketing Studies and Clinical Trials. In letter, Public Citizen’s Deputy Director Peter Lurie MD, MPH, and Sidney M. Wolfe, MD, wrote: “Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach. The guidance makes a sensible distinction between studies that are for efficacy purposes only (“postmarketing commitments….”) and those that have any significant safety element (“postmarketing requirements….”). The categories of studies that can fall under postmarketing requirements (observational studies, clinical trials, animal studies, in vitro studies, pharmacokinetic studies, and interaction/bioavailability studies) are appropriately broad. We urge you to resist any efforts to weaken the draft guidance.” (Emphasis supplied)

To review the draft guidance, go to: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809f1ed1.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

CRO’s Conflict of Interest

Nolan and Auerbach — Mon, 02 Jul 2007 14:42:37 +0000

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). The article points out the inherent conflict of interest for CRO’s to manage clinical trials pre-approval (for NDA submission) and at the same time substantially invest in the pharmaceutical company that is the owner of the drug in trials. Although the FDA is quoted as not seeing the conflict of interest as a problem, and indicating that only 1-2% of inspections of clinical trials uncover fraud, it seems unlikely that the FDA is out looking for such fraud, or has enough resources to police the issue adequately.

To read the complete article; to read more about pharmaceutical fraud.

Pharma Has Its Nose In Clinical Trials

Nolan and Auerbach — Tue, 05 Dec 2006 15:05:52 +0000

A survey published in the New York Journal of Medicine found that more than a third of experts who oversee clinical trials at both medical schools and research hospitals have financial ties to pharmacutical and/or medical device companies. It was further found that some experts had a direct conflict of interest under federal rules; voting on or discussing clinical trials sponsored by companies they had relationships with or competitors of those very same companies. These experts may be part of review boards who are supposed to be insuring the scientific validity of clinical trials and safeguarding the safety of patient participants. Susan L. Rose, executive director of University of Southern California’s Office for the Protection of Research Subjects, said academic institutions had been reassessing their policies and discussing the need for mandatory disclosures.

To read more click here.

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

Nolan and Auerbach — Wed, 12 Jul 2006 17:06:39 +0000

Answer: Monitoring postmarketing study commitments.

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