With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States. Ed Silverman, of the publication STAT, reports that “Among the damaged buildings was a Pfizer plant in Rocky Mount, N.C., that produces nearly 30% of all sterile injectable medicines that the company sells to U.S. hospitals.” In addition, there are reports that a significant amount of finished product was destroyed in the Pfizer warehouse. An event like this also must have had a very negative impact on any active pharmaceutical ingredients, inactive ingredients, and other components of drug products stored there as well.
So what are the options for Pfizer to help right the ship? There are only two that I can see. First and fastest would be to transfer manufacture of the injectable products to another FDA approved facility. Sounds easy right? Not so much. This would involve tech transfer, new sterility studies, and generation of stability data that would need to be completed and generated from the new site. Generation and submission of supplemental regulatory filings would then be required for review and approval by the Agency. This all takes time and lots of it. The only thing that would give Pfizer a break would be that the supplemental submissions would most likely receive expedited review and approval by the Agency. The cause of the storm damage was certainly out of control of the applicant so that criteria alone would be the basis for expedited review. In addition, if any of the impacted Pfizer products would cause a drug shortage, that too would be supportive of special attention and expedited review by the Agency.
Option 2 for Pfizer would be to rebuild and requalify the entire operation. This would provide a much longer runway to recovery. My guess would be that the company would attack this problem by doing both in parallel.
The tornado certainly inflicted a lot of damage, but just look to Al Roker weatherman at NBC for the other bad news. Flooding in the Midwest and on the East Coast continues to further disrupt the supply chain. As many of you are likely experiencing, there is continuing blistering heat across the entire country, with some areas seeing temperatures of 100 degrees for over 30 days. Now maybe it is just the heat causing my mind to start going down the rabbit hole to an entire parade of horrible scenarios that could result from this unusual and deadly weather but here it goes! I am certain, like me, that the FDA must be concerned about this sustained heat and the impact on drug stability. Remember that many patients obtain 90-day supplies of their medication through their local pharmacies or via mail order. What do these temperatures do the drugs stored in homes without AC, or drugs sent through the mail and possible sitting in private mailboxes for 1-2 days or more while the sun bakes down on them? On top of the stability concerns, direct your attention to the nitrosamine impurity issue which appears at least in part to be driven by heat over the shelf life of the product. Certainly proper storage conditions are tenuous (at best) under such an intense and prolonged heat wave. The impact on drugs under such conditions could lead to decreases in potency and for drugs with a narrow therapeutic index, this could present a real problem for some patients.
What will be the long-term impact of the current weather events? Will climate change have a bigger impact on drugs in the future? How will the FDA respond? Will there be an increase in adverse events caused by the impact of heat on our drugs supply? Will some formulations perform worse than others under stress of the weather? Will Mother Nature continue to have a negative impact on our drug supplies and cause more shortages? These are some of the questions I was thinking about at 3AM last night. Hopefully, the problem may be in my mind’s eye, but industry and the FDA need to keep a close eye on what we might see over the next few months of crazy weather!
