Genzyme Reported to be Likely to Enter into Consent Decree With FDA

Genzyme is likely to enter into a Consent Decree with FDA over ongoing cGMP problems at its Allston facility. The company says that FDA plans enforcement action.  Here, reporting from Wall Street Journal today. Blogger Jim Edwards notes a 14-year history of compliance issues at Genzyme on his blog today. For more, read on.  Henri Termeer has been CEO of the company since 1985, and president since 1983.

Perhaps Edwards is being a bit unfair, because, unfortunately, minus the possible consent decree, this history reads like the FDA compliance history of many, many pharma companies today....there's no insidious pattern, and there were gaps of years between citations, until things started to go very, very wrong last year.

Genzyme hired chief compliance officer, Roger Louis, in 1997...which makes one wonder why cGMP compliance wasn't much higher up on the list of priorities.  It seemed to take a drug approval delay and shareholder suit to emphasize the importance of manufacturing compliance.  Are corporate CCO's by definition, so fixated on Sarbanes-Oxley type compliance, and perhaps sales and marketing issues?  In today's environment, it's all too easy to be blindsided and fail to assess potential risks.

The company has no chief risk officer (CRO), like most drug companies today. Not that that would help, since, many observers say, the drug industry doesn't yet have a strong risk-management culture in place.  If it did, would 2008's heparin recall have happened? A recent survey by KPMG, with The Economist, examined some of these issues.

Financial pressures are already having an impact on compliance, in all industries.  Every day seems to bring another medical device recall.  But then there is the unsettling issue of plant safety....For more on this topic (beyond pharma, but then this is a mega-trend), consider the GAO analysis of OSHA's plant safety Business Week, now Bloomberg Business Week---[will he be like Oprah and put his photo on each cover?], recently reported (read here), the government is now scrutinizing figures that showed a drastic reduction in manufacturing plant accidents between 1994 and seems that both companies, and employees, underreported accidents out of fear. 

Genzyme made a number of new appointments, and hired a CMO (never a panacea) to help resolve its Allston manufacturing was likely too soon for these changes to have had an impact. Consent decrees don't come along every day, but this is more evidence that FDA has strengthened its oversight of cGMPs.



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