Does Adversity In BioPharma Manufacturing Build Character Or Reveal It?
By Rob Wright, Chief Editor, Life Science Leader
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When generic pharmaceutical manufacturer Hospira (NYSE: HSP) received an April 2010 warning letter from the FDA over quality compliance concerns at one of its largest plants (Rocky Mount, N.C.), the company temporally shut down the plant to deal with the issues and start remediation. But the dominos continued to fall with Form FDA 483 Warning Letters detailing observations where the plant remained out of line with “current good manufacturing practices” being issued after inspections in June 2011, as well as August 2011. March 2013 brought another FDA inspection and another FDA 483 warning letter. I know the folks at Genzyme’s Allston Landing manufacturing facility can relate to the frustration the Hospira employees must have felt.
Genzyme’s Manufacturing Nightmare
At this year’s BIO International Conference, Christopher Murphy, VP of operations at Genzyme (a Sanofi company), provided the details of what many would probably characterize as a biomanufacturing nightmare. You see, Genzyme was not only the beneficiary of an FDA 483 Warning Letter in February 2009 for its plant in Allston, MA, but in June 2009, the company confirmed it had a viral contamination in one of its bioreactors. Murphy lived in San Diego, CA, at the time with his wife and three young kids (a two-year-old and twin babies). He recalled getting a call on Saturday, seeing if he could be on a plane on Sunday, to start working on the problem by Monday. According to Murphy, the next two months involved tearing the plant apart, decontaminating everything, and then putting it back together, a challenging process he would recommend avoiding. The plant was started back up in August. “The FDA came in on Columbus Day in October, 2009” he shares. “They stayed and inspected us for about six weeks.” In November 2009 Genzyme was issued a 483, which on top of the viral contamination, led to the FDA announcing in March 2010 that they would be taking legal action in the form of issuing a consent decree and a $175 million fine. During his presentation, I asked Murphy, “After doing all that decontamination, how demoralizing was it to the team and you personally?” His response, “It was tough. Many of these people that worked at this plant had worked there for 10 to 15 years. The plant had felt very confident about its ability to be compliant.”
The efforts of Hospira and Genzyme might have you thinking, “No good deed goes unpunished.” At the time, I imagine there was probably a bit of that feeling within the ranks of both companies. But it seems neither company played the, “Oh, woe-is-me card,” nor the blame game so common in other manufacturing industries. I have searched through published documents and have yet to find anyone at either company stating the FDA was being unfairly critical or assigning blame to one or more of their suppliers. Instead, it seems both companies took positions of being accountable, and we can learn a lot from companies and leaders who use adversity to reveal character.
Manufacturers Go From Failure To Finest Hour
While attending tradeshows and conferences, people often told me that they expected both Genzyme and Hospira to eventually close these plants. And maybe that would have been the easy thing for leadership to do. But Genzyme knew it had rare disease patients counting on them to succeed. Hospira’s Rocky Mount plant, which makes injectable drugs, when at full capacity, employs more than 2,500 and accounts for 25 percent of the company’s nearly $4 billion in annual revenue. Peoples’ lives and livelihoods were at stake. Failure was not an option. In my opinion, both of these companies took what could have been tragedies and instead turned them into their finest hours.
In the June 2014 issue of Life Science Leader magazine, we published an article based on an interview with Sandra Poole, who in 2009 was the newly appointed head of Genzyme’s Allston plant, arriving just days after it was shut down. Poole shared a number of lessons learned from the experience, and some great insights should you find yourself in a similar situation. But during Murphy’s presentation at BIO, I gained some additional insights. For example, he shared how the company took an active approach toward capturing best practices from the process, because they were gaining some very unique experiences and competencies. You might be surprised that one of the challenges Genzyme faced was dealing with a flood of applications for people wanting to work at the plant. Though this may seem odd, if you think about it, working in a facility under a consent decree is probably a pretty good resume differentiator. Another interesting tidbit he shared involved the sending of emails on the weekend. During the cleanup project people were working very long days, and weekends were key for rejuvenation. Murphy recalled weekends being important for him as well. However, if he thought of something, he might fire off an email to the team so he didn’t forget. Though his intentions were pure, for those on the receiving end, it was another reminder of the mountain of work awaiting them on Monday morning. Murphy admits it never dawned on him how someone getting an email from him on a Saturday could be hard on their morale, until he began to receive them from his new boss. The solution was to put in place a software system which delays any emails written over the weekend from being sent until Monday morning. This may seem like a little thing, but when it comes to building and maintaining the employee morale of those charged with fixing the problem, it is often the little things which can make the biggest difference.
On July 30, 2014, Hospira announced strong second-quarter earnings results. Also contained within this release the company noted the FDA had made its “long anticipated reinspection of the troubled plant in Rocky Mount, North Carolina and found no additional manufacturing issues there.” For CEO F. Michael Ball, being able to report to analysts that the plant is operating at near full capacity must have been extremely gratifying. In 2012, when we were putting together our annual CMO Leadership Award Issue, the cover image is a great representation of how folks at Hospira might have first felt, as well as their customers, upon the receipt of bad news from the FDA. I know Hospira’s situation served as inspiration for the issue’s Editor’s Note – Does Your CMO Have A Contingency Plan, as well as the sidebar I wrote on p. 24 – Does The CMO Apple Fall Far From The Branded-Parent Tree?
It would be nice to pretend to be a fortune teller and claim, “I knew all along Hospira and Genzyme would succeed.” But doing so would be stealing the thunder from the employees who gave their all to make these success stories happen. But what I can say with conviction — I have always been a fan of the underdog winning despite the odds makers prognosticating “it can’t be done.”