Pharma manufacturing consent decrees: 16 black holes
There's an emboldened FDA today, intent on measuring up under a keenly interested Congress. Though the regulator has been talking about executive prosecutions lately, for decades it has wielded consent decrees as an enforcement tool for those who repeatedly violate the rules.
The consent decree is judicial recognition of an agreement between FDA and drugmaker that usually bars the drugmaker from manufacturing and distribution until it can prove, via third party, that it has achieved and can sustain regulatory compliance. The decree often involves 7- or 8-figure financial penalties that the offending company pays to the government general fund, says Jim Prutow, a partner at consultancy PRTM and director for its healthcare practice. That way the regulator has no direct incentive to fine. Another stipulation: the drugmaker must hire a consultant to advise in the operations overhaul. PRTM is one such firm.
Pharma manufacturing consent decrees run for years. In the recent case of Genzyme, for example, the remediation effort will take four years, according to the company, followed by three years of watch by the FDA.
But seven years is quick. Of 16 consent decrees recently examined by Prutow and PRTM researchers (summarized in the following pages), one has stretched for 21 years and is still in force; another, 17 years and counting. The majority of manufacturing consent decrees linger, remaining in force with no official closeout.