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FDA stung by damning fraudulent research report

Agency accused of leaving untested drugs on the market

FDA headquarters White Oak

The US Food and Drug Administration (FDA) has come under fire from a heavily critical report into its handling of a case of manipulated test data.

An investigative report by New York-based, non-profit journalism foundation ProPublica, focuses on the agency's response to record tampering and manipulated test data at the Houston, Texas office of contract research organisation (CRO) Cetero Research.

In 2010, the FDA was alerted by a whistle blower within the CRO to allegations of fraudulent misconduct in the handling of test data.

The documents the FDA investigated involved 1,400 trials, between 2005 and 2009 for about 100 drugs, including chemotherapy compounds and prescription painkillers, that were subsequently approved.

Despite the gaps in the scientific evidence for the safety and efficacy of a large number of these drugs, the ProPublica report - FDA let drugs approved on fraudulent research stay on the market - claims the regulator has allowed many of the Cetero-tested drugs to remain on the market today.

The FDA's chief of drug reviews Dr Janet Woodcock defended the agency's conduct, saying: "It is non-trivial to have to redo all this, to withdraw drugs, to alarm the public and the providers for a large range of drugs.

"To repeat the studies requires human experimentation, and that is not totally without risk."

She added that the agency's risk assessment found the potential for harm from the drugs tested by Cetero was "quite low".

ProPublica, however, further criticises the agency for providing "virtually no public disclosure of what it had discovered", and for refusing to name the drugs involved.

It also criticised the FDA's decision to withhold details of the risk assessment, an omission, it says, that meant the agency failed to meet its obligations to the public.

"If there are problems with the scientific studies, as there have been in this case, then the FDA's review of those problems needs to be transparent," David Kessler, a University of California, San Francisco professor who headed the FDA from 1990 to 1997, told ProPublica.

Putting the agency's reviews of the affected products in public view, Kessler argued, would allow the medical community to "understand the basis for the agency's actions". 

He added: "FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it's just a black box."

Meanwhile, the FDA has said its investigations are "fluid" and "ongoing".

Read the full report here.

19th April 2013

From: Research, Regulatory



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