Schering Plough - Pharma manufacturing consent decrees

Start Date: 2002
Financial penalties: $500 million; missed-deadline fines; $500,000 for initial inspections; unknown cost of subsequent inspections
End Date: 2007

The scope and fines give this decree legendary status, and it embodied in 2002 an aggressive FDA posture that's similar to its posture today around executive prosecutions. "The agency has allowed itself to get into this situation of issuing warning letter after warning letter to the same company, without taking any action," said Eric Blumberg, the FDA's deputy chief counsel for litigation, in May 2002 when he signed the consent decree. And just this month, in reference to pharma marketing violations, he said, "It's clear we're not getting the job done with large, monetary settlements. Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress."

GMP violations concerning its albuterol inhaler contributed to this consent decree, which was described in 2002 as a shot across the bow of the pharma industry. The action affected four manufacturing sites and 125 products, about 90 percent of the drugmaker's offerings. Production was suspended for 73 of them.

Transgressions spanned the operations spectrum: manufacturing, quality assurance, equipment, laboratories, packaging and labeling.

In addition to the financial penalties levied, the FDA withheld approval of the company's allergy medication Clarinex. Company shares fell 15 percent in a day, and investors filed a $165-million class action suit.

Schering Plough - Pharma manufacturing consent decrees