The FDA has taken the rare step of disbarring, or banning, for 5 years, four men who oversaw the quality control activities of a now-defunct New Jersey generics manufacturer.
The actions were posted this week in the Federal Register against the men, all of whom previously pleaded guilty to felony charges related to their efforts to hide from the FDA an alarming list of manufacturing failures at Able Laboratories, reports Pharmalot. Disbarred are Shashikant Shah, who was a vice president of quality control and regulatory affairs; Ashish Macwan, a former assistant manager in quality control who oversaw chemists and what turned out to be the company's non-compliance with Good Manufacturing Practices; Jyotin Parikh, a quality control laboratory manager; and quality control chemist Jose Concepcion.
The Cranbury, NJ, company, which made blood pressure medications, among others, closed up shop and filed for bankruptcy in 2005 after its secrets were uncovered and a nationwide recall of all of its products initiated. Pharmalot reports that among its many shortcomings, Able did not report samples that failed to pass quality control tests, instead retesting until they got the results they needed. The company also didn't report when its drugs didn't meet potency standards. The company apparently fooled the FDA for years by cutting and pasting test results in records and managed to even get new drugs approved during the time that it was falsifying documents.
Shah was sentenced to 18 months in jail, because, the FDA said, he hid company failures of all kinds from the FDA from 1999 through 2005. He also settled with the SEC on charges that he benefited from insider trading. The other three men received probation.
There is no indication any of the men are currently working in the industry, but woe to any company that uses any of their services. The disbarment notice says the four men are not to provide any services to any company "with an approved or pending drug product application." It further states any "person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services," of any of them in any capacity during their disbarment will face civil financial penalties of their own. Additionally, their drug applications will be rejected and not reviewed by the FDA.
- read the Pharmalot piece
- here's the bankruptcy notice
- here's the disbarment notice from the Federal Register (.pdf)