Clinical Researcher Debarments Proceeding Slowly, Despite FDA Promises Of Reform
This article was originally published in The Pink Sheet Daily
Executive Summary
It still takes years to debar a physician convicted of a crime from conducting clinical research.
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FDA is still taking years to debar clinical investigators convicted of crimes from conducting clinical research despite promises of reform, having just now permanently debarred a man convicted of wire fraud more than four years ago. Ray Nathan pleaded guilty to wire fraud and was sentenced to probation and a $5,000 fine in U.S. District Court for the District of Massachusetts on May 3, 2007, but his permanent debarment order is dated July 7 and scheduled for publication in the Aug. 9 Federal Register. It has been two years since FDA announced that it was making significant progress in improving the efficiency of disqualification and disbarment (Also see "FDA Will Move Faster To Ban Bad Actors From Clinical Trials" - Medtech Insight, 17 Aug, 2009.). The General Accountability Office issued a report on delays and loopholes in FDA's disqualification and debarment authority in October 2009, and Rep. Joe Barton, R-Texas, expressed interest at that time in pursuing legislation to give FDA expanded debarment authority (Also see "FDA Will Revise Investigator Disqualification Regs In Response To GAO Report" - Pink Sheet, 2 Nov, 2009.). Nathan was a founder of a startup drug company called Argus Therapeutics, and he pleaded guilty to pretending to be someone else in an e-mail message in an attempt to obtain the certificate of analysis for the renal drug PhosLo (calcium acetate) so that his company could manufacture a generic version of it. The drug was owned at the time by Nabi Biopharmaceuticals and manufactured for it by Lyne Laboratories. Nathan admitted impersonating a Nabi employee to get the certificate of analysis from a Lyne employee. Nabi sold PhosLo in October 2006 to Fresenius Medical Care for up to $150 million in upfront cash, milestone payments and royalties on sales of a new product formulation under development (Also see "Genzyme Optimistic About Renagel’s Future Despite Fresenius’ Deal For PhosLo" - Pink Sheet, 16 Oct, 2006.). Generic versions of the product are available. Hearing Request Denied Nathan requested a hearing to fight the FDA debarment order on the grounds that "his actions to obtain a certificate of analysis for PhosLo do not relate to that [drug development] process but instead relate to 'pre-development' market research." FDA rejected that argument as "not convincing." Other recent debarment orders also came years after the original criminal convictions. For example, from March 3 through Aug. 8, FDA debarred 10 physicians for three, four or five years each, or in some cases, permanently, for administering to patients an unapproved botulinum toxin type A drug, Tri-toxin, manufactured by Toxin Research International, Inc. as a research drug, instead of Allergan's approved Botox/Botox Cosmetic. In one case, an unapproved Chinese product was used instead. All of the criminal convictions these debarments were based on were imposed between March 2006 and June 2008. Unlike Nathan, none of these defendants requested a hearing to fight the FDA debarment orders. -Martin Berman-Gorvine ( [email protected] ) |