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.”
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.