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FDA nixes banned exec's effort to return to the biz

Investigators said tools got ground up in Alra drugs
Tools

The FDA says no deal to a former generic drug exec who wants to get back in the biz. The former top executive of a Chicago-area drugmaker that was alleged to have sold drugs after tools and steel wool were ground up with ingredients remains banned from running any FDA-approved company.

The agency has upheld the debarment of Baldev Raj Bhutani, the former president and treasurer of generic drugmaker Alra Laboratories, Regulatory Focus reports. According to the FDA decision, the company failed on any number of manufacturing quality fronts, allowing "decomposed raw material in finished drug products and deviating from approved manufacturing procedures by adding an undocumented substance, sodium hydroxide, to drug products in an unapproved manner." A Chicago Tribune story cited by Regulatory Focus outlines the tool grinding episode.  

Problems were so severe and so chronic at Alra that federal agents in 1991 raided the facility and seized box loads of drugs. FDA warning letters from 1997 list ongoing problems at the company.

Bhutani applied to have the debarment time shortened under a provision that allows the agency to review the ban if the affected official provided significant help to investigators. The FDA said no deal, that he had not done enough.

The agency has disbarred other executives, a practice that is controversial. The best known case involves three former executives of Purdue Pharma caught up in a case against the company and its OxyContin drug. They also sought to have their bans overturned, but a U.S. Court of Appeals this summer said the agency was within its rights to keep them away from companies making FDA-approved drugs.

- read the Regulatory Focus story
- see the FDA's decision (pdf)
- here's the warning letter

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