From the Editor: GMPs in the Courtroom

The connection between cGMP’s and fraud is difficult, but possible, to make. Expect more people to try.

By Agnes Shanley, Editor in Chief

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Last month brought news that a former GSK QC manager Cheryl Eckard was awarded a $96-million judgment, resulting from a qui tam whistleblower case she launched in 2004. She had complained to her employer about manufacturing problems at its plant in Cidra, Puerto Rico, slowly moving higher up the chain of command, until she finally telephoned the company’s CEO Jean-Pierre Garnier. Her call was not taken, and she was fired in 2003.

Two years later, GSK entered into a Consent Decree with FDA for serious problems at the facility, including improper active ingredient dosing. The plant was shut down several years ago. Glaxo will pay a $750-million fine for manufacturing fraud.

A $650-million consent decree. A $750-million fine. Can any executive at any pharmaceutical company, anywhere in the world, fail to see the savings that might have been realized by simply meeting quality requirements, but then also investing in the improved technology and training that quality demands?

Eckard’s was not the first pharma whistleblower case to invoke cGMP’s but it’s the first so far to succeed. Mark Livingston, a trainer at Wyeth, sued that company six years ago, only in his case calling on whistleblower protection provisions of Sarbanes Oxley. In that case, too, the drug manufacturer had performance problems that led to a Consent Decree. Whether he was a disgruntled employee, as Wyeth management alleged, whether there were holes in his argument, or whether his lawyers made a tactical error by invoking SOX, Livingston lost his case.

One thing is clear: pharmaceutical manufacturers can expect to see more whistleblower cases come forth. Finance reform will help drive this trend, according to PharmaCompliance blogger, lawyer Jamie Ghen. The Health Care Education Reconciliation Act and the Dodd-Frank Wall Street Reform and Consumer Protection Act will expand SOX’s whistleblower protection provisions, while giving employees more financial incentives for blowing the whistle on questionable practices.

Manufacturers must be ready, experts suggest, and review (or develop) corporate policies. It’s generally good policy to treat any whistleblower with kid gloves, writes attorney John Fleder in a recent edition of FDLI Update. Pay close attention to exit interviews with disgruntled employees who leave your firm or are let go, he says, because their complaints can allow you to gather information for further investigation. Respond repeatedly, he advises, in written and easily recovered formats, to the whistleblower’s concerns.

Not all cGMP complaints will have any merit in a whistleblower case. Relatively minor violations that are then covered up in false documentation won’t cut it, says attorney Kenneth Nolan, with the qui tam specialists Nolan and Auerbach, but more serious violations of cGMP that could result in unsafe for ineffective products could make a case.

Some potential problems, he says, would include:

  • Accepting or validating products or active ingredients that failed to meet internal specs or quality standards
  • Documenting label review when it hasn’t occurred
  • Falsely describing testing methods
  • Failing to document any and all complaints received about a medication

And the list goes on. Some of the 483’s and recalls that the industry has seen recently reveal these problems, in various stages of ripening. Could they be whistleblowing cases in the making?

In the end, the outcome is up to you, and those running your companies. Perhaps the best defense is not a good lawyer, but strong quality systems and dedication to compliance, whatever it costs.

On one pharma LinkedIn group recently, someone asked whether cGMP’s have simply become too expensive, given today’s competitive pressures. Not observing them will cost far, far more. Is it worth it?

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