Bankrupt CEO Offers FB Gift Coupons for Clinical Trial Subjects
March 25th, 2013 // 4:14 pm @ jmpickett
Last year, PRACS Institute emerged from the ashes of Cetero Research, a troubled contract research organization that filed for bankruptcy after the FDA alerted drugmakers to reevaluate clinical tests conducted due to falsified data and manipulated samples (back story). Now, though, PRACS has folded and late last week filed for bankruptcy, leaving drugmakers and clinical trial enrollees in the lurch.
The CRO filed a Chapter 7 petition, which is what companies do when they intend to liquidate, was filed on Friday in bankruptcy court and all four of its facilities – in Fargo, North Dakota; St. Louis, Toronto and Ontario, Canada – were quickly shuttered. Another facility in San Antonio, where the bankruptcy filing took place, was closed last fall.
- April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance
- April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission
There was no information available about PRACs finances in the initial court filing, although a lengthy list of creditors included such name as Actavis, Apotex, Cipla, Teva Pharmaceuticals, Boehringer Ingelheim, Endo Pharmaceuticals, Merck, Mylan Laboratories, GlaxoSmithKline, Novartis, Perrigo, Pfizer and Ranbaxy Laboratories. Other creditors include the US Attorney in Fargo and the Drug Enforcement Agency (read here).
Not mentioned are the many people who enrolled in clinical trials that PRACS was conducting. Over the past few days, some of these people were complaining on the PRACS Facebook page for the Fargo location. “I was told to pick up my check on Wednesday, but received a call that checks won’t be ready till (sic) Thursday. Went Thursday and PRACS was closed,†wrote one disappointed participant.
May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy
Phone calls placed to the various PRACS locations were no longer being answered by the end of last week, leaving some to wonder if they would ever get paid and others to infer a lawsuit may ensue. PRACS, however, did appear to offer some form of compensation. A message posted on the Facebook page for the Fargo facility indicated local businesses were stepping into the breach.
“We would like to let people know that we have received a generous donation from Maxwells (which is a restaurant) and Artisan Home Furnishings. Any PRACS study participant who was not compensated for their time may receive gift certificates for up to $100. Simply bring in your paperwork to either location and ask for the site manager,†the message reads (see here).
Meanwhile, there is no word on whether gift certificates will be distributed to any of the drugmakers or the various federal agencies that are also creditors. Presumably, any number of them could use a nice chair or a good meal. We left a message for an attorney representing PRACS and will update you accordingly.
Upcoming Expertbriefings.com Webinars
- April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance
- April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission
- April 16 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, and 21 Tips and Tricks for Your Next Audit
- April 18 – Why You May Want to Move Your Pharma Company to Kansas – 483 and Warning Letter Trends
- April 30 – FDA Hands Out CAPA 483s Like Candy – Avoid Them With a Closed Loop CAPA SystemÂ
- May 1 – Avoiding Warning Letter Disasters With a Strong Contractor Quality Agreement
- May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy
