Monday, April 15, 2013

Report Slams FDA's Response To CRO's Fraudulent Study Data

Fierce Biotech has;
Report Slams FDA's Response To CRO's Fraudulent Study Data
April 15, 2013 | By 

The FDA is feeling the sting from defunct Cetero Research's fraudulent drug trial data nearly three years after investigators raided the CRO's Houston labs. ProPublica has written a critical report on the agency's response to the fraudulent findings from Cetero's labs, citing sources that call out the regulator for acting slowly and keeping the public in the dark.

While the FDA's chief of drug reviews, Dr. Janet Woodcock, defends the agency's response, the report highlights that Americans are still taking drugs approved based on tainted study data that call the safety and efficacy of the meds into question. Many of the some 100 medicines in question from the studies that Cetero conducted were generics, yet the article points out that some of the manufacturers have missed their deadlines for submitting new data for those meds and the agency has completed less than half of the reviews on the 53 submissions that have come in.

True to cause over at ProPublica, the article homes in on what critics called a lack of transparency on the part of the regulator in dealing with the mess from the fraudulent data. The European Medicines Agency has already outshone the FDA in the eyes of advocates for opening data from clinical trials to the public and research community, taking controversial steps to mandate that all trial data become widely visible. And this new report credits the EMA with swift action in removing drugs approved with data from Cetero's studies in an unflattering comparison with the FDA's response.

"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, said, as quoted by ProPublica. He advocated for putting the agency's reviews of the affected products in public view to let the medical community "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."

As this report shows, Cetero Research's scandalous practices from years ago continue to reverberate today. After the CRO folded, the business reformed as PRACS Institute only to collapse again last month, stranding study patients and leaving a list of workers and creditors unpaid. Those creditors include big names in the industry such as Boehringer Ingelheim, GlaxoSmithKline, Merck and many others.
- check out the ProPublica article

Related Articles:
PRACS' CRO implosion leaves a Who's Who of biopharma creditors in its wake
Report: CRO with a scandal-plagued past shuts down, leaving patients stranded
New CRO owners hope new name, new CEO will clear way to new rep

Thank You Fierce Biotech and Mr McBride

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