FDA Disbars Four Able Lab Employees

FDA Disbars Four Able Lab Employees

April 9th, 2012 // 2:39 pm @ jmpickett

Seven years ago, a little-known generic drugmaker landed on the national radar screen in a big way. Able Laboratories was cited by the FDA for all sorts of serious problems that resulted in one of the largest product recalls ever, and the implications were widespread since the drugmaker made billions of tablets and capsules for treating high blood pressure and chest pain, among numerous other ailments.

Among the infractions: routinely retesting samples that failed quality control tests until they passed; failing to report results when drugs failed potency or other tests, and reporting only passing test results, but not failures, after receiving FDA permission to halt a quality-control test. The culprits included Able executives, supervisors and lab analysts (here is the 483 report). In 2007, several people pleaded guilty to the scheme and implicated the former ceo (back story).

Late last year the next shoe dropped, when four individuals each pled guilty to one count of conspiracy against the US, a felony that allows the FDA to seek disbarment. And that is exactly what the agency is now doing. In notices published in the Federal Register this week, and first reported by Pharmalot, the FDA has disbarred the quartet for orchestrating the scheme (read here, here, here and here).

Who was involved? Shashikant Shah, a vp of quality control and regulatory affairs, who oversaw 100 employees; Ashish Macwan, a former assistant manager in quality control, who was responsible for supervising chemists and monitoring compliance with current Good Manufacturing Practices; Jyotin Parikh, a laboratory manager in quality control; and Jose Concepcion, a chemist in quality control.

Court documents show that Macwan, Parikh and Concepcion were given probation, but Shah was sentenced to 18 months in jail (see this). In its explanation, the FDA noted that, from 1999 through 2005, Shah oversaw all sorts of failures, manipulations and falsifications that allowed Able to continue selling its drugs or receive FDA approval for new meds.

“In furtherance of the conspiracy, in or around 2002, Mr. Shah supervised the falsification of testing data for Able’s butalbital, acetaminophen, and caffeine products. In or around 2003, Mr. Shah supervised the falsification of testing data for Able’s methylphenidate product,” the FDA writes. “Mr. Shah additionally directed and supervised the creation of false and fraudulent entries in chemist laboratory notebooks, and in the corresponding process validation binders, relating to Able’s abbreviated new drug application for lithium carbonate extended release tablets, for which Able received FDA approval on or about April 21, 2003.”

In 2007, Shah had settled civil charges brought by the US Securities and Exchange Commission, which alleged he received $909,000 in insider trading profits over a 16-month period by selling Able stock while in possession of “non-public information about Able’s faulty quality control testing practices.” As part of the civil settlement, Shah agreed to repay the profits