By Walter F. Roche Jr.
Though it has garnered little public notice the U.S. Food and Drug Administration has placed a lifetime ban on the role a former drug company owner can play in seeking approval of new drugs.
The lifetime ban was imposed on Nov. 30 of last year on Barry J. Cadden, the former president and part owner of the New England Compounding Center, the company at the center of a deadly 2012 fungal meningitis outbreak.
The FDA order, which Cadden did not contest, bars him from providing services in any capacity to a party that has an approved or pending drug product application.
In addition the order states that any party with an approved or pending drug product application "who knowingly employs or retains " Cadden as a consultant, contractor or in any capacity "will be subject to civil penalties."
Finally the notice states that the FDA will not accept or review any abbeviated drug application from Cadden.
The notice states that the debarment was prompted by Cadden's June 27, 2017 conviction on racketeering, conspiracy, mail fraud charges and violations of the Food, Drug and Cosmetic Act. It specifically notes Cadden's conviction for defrauding the FDA.
Cadden, whose federal sentence was recently upped from nine years to 14.5 years is also facing second degree murder charges in Michigan. If convicted on those state charges he could likely be jailed for life.
Cadden already surrendered his Massachusetts pharmacist license.
The notice states Cadden can petition to end the disbarment.
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