FDA Consent Decrees: the Cost of Doing Business?

The strategic reasons behind the acquisition in the works for Sanofi to purchase Genzyme are clear. It was a matter of fixing a sale price that reflected the true current and future value of Genzyme.

For those of us in the quality assurance and regulatory compliance professions, there has been the curiosity of how the history of manufacturing and compliance woes at Genzyme would factor into the sale price.  I guess we’ll never know. But it is interesting that a financial analyst would minimize this kind of problem leading to a consent decree as “the cost of doing business.”

Jim Prutow, a partner in the health care practice at the PRTM consulting firm, says of the Sanofi-Genzyme deal: “… regulatory actions including consent decrees are increasingly part of the cost of business, and it is not the ‘death knell’ to a company’s growth and acquisition options that it was in the past.” 1

This points to the frustration at FDA on finding the right lever to pry some companies into compliance with the laws and regulations directed toward drug safety and efficacy and patient protection. Fines alone are ineffective, because they are just considered to be the “cost of doing business.” (And to whom are these costs passed on?)

Eric Blumberg, the FDA’s deputy chief counsel for litigation, prophetically said in May 2002 when he sign the Schering-Plough consent decree, “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.” 2 (See The QA Pharm 11/6/10.)

What might we expect for the future of Genzyme’s compliance profile as a result of the acquisition by Sanofi?

Christopher Viehbacher, Sanofi-Aventis CEO, says Sanofi can help Genzyme deal with its FDA consent decree and create “a culture of quality.” 3

But Richard L. Friedman, Director of the FDA Division of Manufacturing and Product Quality and Diana Amador-Toro, Director of FDA New Jersey District have recently weighed in on the subject of quality at Sanofi:

  • A Warning Letter was issued on January 28, 2011, at the Sanofi location in New Jersey 4 cited serious violations of failing to report serious and unexpected adverse advents in a timely manner. Examples given were as much as 896 days late.
  • A Warning Letter was issued on February 9, 2011, at the Sanofi location in Germany 5 cited serious violations relating to sterility assurance and contamination control. Examples given included the repeat observation (from 2008) of failing to identify microorganisms recovered from sterility tests.

We can only hope for the sake of Genzyme’s patients who have rare, devastating lysosomal diseases that the connection is soon made between regulatory compliance and continuous supply of quality products at the most economical cost—with or without the help of Sanofi’s “culture of quality.”

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republished and adapted with permission from The QA Pharm

1 Silverman, Ed, Sanofi Gobbles up Genzyme: What the Wags Say, Pharmalot 2/16/11.
2 Miller, George, Schering-Plough Pharma Consent Decrees, FiercePharma, 10/19/10.
3 Staton, Tracy, Sanofi caps Genzyme persuit with $20 Billion Deal, FiercePharma, 2/17/11.
4 Warning Letter 11-NWJ-06, 1/28/11, Sanofi-Aventis US.

5 Warning Letter 320-11-09, 2/09/11, Sanofi-Aventis Deutchland.

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