Taking The Well Out Of Wellbutrin
Make a commentBy Ed Silverman // April 9th, 2008 // 1:01 pm
The string of issues facing this pill - brand-name and generic - is enough to leave you, well, depressed. For instance, the FDA continues to investigate a generic version of the antidepressant that is marketed by Teva Pharmaceuticals, due to adverse events reported to the agency. Now, some of the 300 milligram brand-name Wellbutrin XL, which is made by Biovail and sold in the US by Glaxo, has been recalled because foreign materials were embedded within the tablets, according to the FDA.
Meanwhile, Anchen Pharmaceuticals, which sells a 300 milligram generic Wellbutrin, may have succeeded in getting its pill to market by poaching key employees from an unnamed rival, according to a lawsuit filed in a California state court by a former Anchen employee. An example cited was David Balucci, who was hired in February 2006 as director of validation and facilities management by Anchen ceo Chih Ming Chen without the usual vetting. He was allowed to work from home and paid $30,000 more than the industry average, even though some Anchen managers believe he wasn’t qualified.
In fact, Balucci had already moonlighted for Anchen before switching jobs, and he wasn’t the only one to have done so, according to the suit. “It appeared that Anchen was attempting to pay off Mr. Balucci for the work he had already done and ensure that his prior involvement and knowledge would not cause any future problems for Anchen with its ANDA filings, generic Wellbutrin launch, (an) upcoming FDA inspection, licensure or operation of its new manufacturing plant,” the lawsuit alleges. The unnamed rival was likely Watson Pharmaceuticals, which also sells a generic Wellbutrin.
“Since 2004, Mr. Balucci had designed validation protocols, performed validation studies, documented validation data and personally prepared and signed the validation reports submitted by Anchen to the FDA. Mr. Balucci utilized (the rival’s) validation protocols and methods on Anchen’s manufacturing equipment in order to expedite the acquisition of certain key data and the facility licensure,” according to the suit, which was filed by Kellie Ann Moore, who claims she was wrongfully fired from her job as corporate counsel.
There’s nothing to suggest this string of events compromised the 300 milligram generic Wellbutrin now sold by Anchen, which also has a deal to supply Teva with a 150 milligram dose. An FDA spokeswoman tells us that only the Teva pill is being reviewed. But the timing is certainly unfortunate - the lawsuit does raise questions about Anchen’s practices and judgement at a time when branded and generic Wellbutrin is under a microscope. Both Chen and John Mooney, Anchen’s general counsel, had no comment. Moore’s attorney didn’t respond to messages. And Balucci couldn’t be reached.
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