Cetero - FDA

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FDA Cites Cetero for " Faking Research " -

http://www.reuters.com/article/2011/07/26/us-fda-cetero-violation-idUSTR

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FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero

Research May Require Reevaluation

Posted July 27, 2011

FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero

Research May Require Reevaluation

The FDA is notifying pharmaceutical companies that bioanalytical studies

conducted by Cetero Research, Houston, Texas (Cetero) between April 2005

and June 2010 in support of marketing applications may need to be

repeated or confirmed. Cetero is a contract research organization (CRO)

that performs bioequivalence and pharmacokinetic testing for a number of

pharmaceutical companies.

The FDA is asking drug sponsors to identify those tests conducted by

Cetero during the designated time frame that were used to support New

Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

Drug sponsors will need to determine whether any of the testing

performed by Cetero should be re-done.

Also, the FDA will send letters to drug sponsors with pending

applications, requesting that they either repeat the bioequivalence

testing done by Cetero or retest drug samples using a different test

laboratory or contractor.

It is unlikely that these concerns relating to data integrity affect the

overall safety and efficacy of drugs already on the market and, at this

time, there is no evidence of problems with the safety, quality, purity

or potency of drugs already approved. However, as a precautionary

measure the FDA is asking drug sponsors to review the testing in

question conducted by Cetero to make sure that data are completely

reliable.

FDA is taking this action as a result of two inspections of Cetero's

bioanalytical facility in Houston, Texas conducted in 2010, as well as

the company's own investigation and third party audit. The inspections

and audit identified significant instances of misconduct and violations

of federal regulations, including falsification of documents and

manipulation of samples.

The pattern of misconduct was serious enough to raise concerns about the

integrity of the data Cetero generated during the five-year time frame.

FDA concurs with the assessment of Cetero's independent auditor who

stated, " This misconduct appears to be significant enough to cast doubt

on the data generated...If the foundation of the laboratory is corrupt,

then the data generated will be also. " As noted in a letter FDA sent to

the company, Cetero also failed to conduct an adequate internal

investigation to determine the extent and impact of the violations and

failed to take sufficient measures to assure data integrity within the 5

year time frame.

As noted in the July 26 letter sent to Cetero, " FDA has reached this

conclusion for three reasons: (1) the widespread falsification of dates

and times in laboratory records for subject sample extractions, (2) the

apparent manipulation of equilibration or 'prep' run samples to meet

pre-determined acceptance criteria, and (3) lack of documentation

regarding 'prep' runs that prevented you from conducting an adequate

internal investigation to determine the extent and impact of these

violations. "

Read more: FDA Notifies Pharmaceutical Companies that Studies Conducted

by Cetero Research May Require Reevaluation - FierceBiotech

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S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

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Email: dkalman@...

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