For Years, pharma has been the villain in most public opinion polls. But now, the tide seems to be turning. Last month brought buzz about the film, Extraordinary Measures. You’ve no doubt heard all about the inspiring story of John Crowley, a pharmaceutical exec who quit his job to fund research into cures for Pompe disease. Not only did he save the lives of his own, and many other, children, he opened up the field of orphan drugs.
Although critics are lukewarm, they say the movie does reveal to the public more of the complexity and challenge of drug development and manufacturing. What could be better than that? But lately I’ve been wondering about the “other” side of manufacturing—the side that could never make it to Hollywood: cGMPs and quality control. Drug recalls in the U.S. have been trending upwards. In the U.K., according to a recent study by Blueview Group, drug and medical device recalls increased 400% between 2004 and 2008, due mainly to manufacturing defects, packaging or labeling issues, or compromised sterility.
Pharmaceutical quality control reached a climax in the news last summer, after FDA issued Genzyme a 483 for cGMP problems at its Allston Landing plant. This plant manufactures the orphan drugs Cerezyme and Fabrazyme, worth nearly $2 billion in sales each year. A dissident shareholder, Relational Investors, sued the company, its principal alleging that Genzyme overpaid for acquisitions and underinvested in manufacturing. The problems cost Genzyme dearly, as FDA did not approve its improved Pompe disease treatment (which is now being re-evaluated) and reportedly streamlined the approval process for a competitor’s product. Last month, Genzyme hired a new QC chief, and contracted with Hospira to handle filling. Relational withdrew its suit, and hopes to settle its diff erences with the company.
But the question still lingers. Is the industry, in its desperate attempt to acquire innovation and reinvent itself, underinvesting in core quality control operations? Last month saw another major pharma company, J&J, dogged by quality control issues. Th e company has led the industry in Lean Six Sigma and operational excellence initiatives, so this news may have surprised some. But J&J had to recall more lots of Tylenol and other over-thecounter medications, which were tainted with a chemical used to treat wooden pallets. FDA alleged that J&J was aware of the problem a full year before it took action.
It’s easy to point the finger at senior management. But is that the whole story? Is everyone on your team being rigorous about quality? We often lament about pharma’s silos and its “data rich, information poor” problem. But that doesn’t mean that each and every critical data point shouldn’t be recorded, transferred and shared. Last month, we interviewed experts on the topic of tech transfer, and found that people oft en fail to transfer basic information to internal partners, or external CMOs. Information is missing, isn’t recorded, and, in deals involving China and Japan, isn’t translated. And analytical methods and SOPs are the areas where people most often trip up. This has an obvious impact on CAPA and fundamental quality control.
Contributing editor and NIR expert Emil Ciurczak suggests that some have “gotten lazy and stupid” about documenting critical details. “Everything you need to know to pass an FDA inspection you learned in freshman chemistry class,” he says. One industry consultant recalls a consent decree in the 1980s, where a lab technician openly admitted to FDA to taking notes down in pencil, then changing them to ink later on. She also responded to questions about an SOP. “Nobody does it that way,” she said. “Everyone knows it won’t work that way.”
“How could anyone have hired such an incompetent tech?” you ask. But is it really that farfetched? Read any 483’s lately? It’s the ordinary measures, as well as the extraordinary ones, that count.
