In the early morning hours of Sept. 20, 2017, Hurricane Maria slammed into the southeast coast of Puerto Rico and tracked across the island with maximum sustained winds of 155 mph, leaving a trail of catastrophic destruction in its wake. The Category 4 cyclone knocked out the island’s power grid that ran the manufacturing plants of Baxter International, a major supplier of IV saline bags used by healthcare professionals across the United States to administer intravenous drugs. Baxter’s plants were offline for months, causing a severe shortage of 50 ml and 100 ml IV bags. Production volume of the bags is only now reaching pre-Maria levels.
The historic hurricane was an obvious event that slowed the flow of IV fluid to a trickle, but other causes of drug shortages are more subtle — and more persistent. Pharmaceutical companies hit with FDA warnings for failing to comply with quality medication production standards has led to massive recalls and forced some manufacturing plants to shutter, putting more strain on other drug producers that might not have the capacity or resources to fill the void. In September 2015, Pfizer acquired Hospira in a major merger involving companies that make a vast majority of injectable medications. Pfizer inherited Hospira’s manufacturing plants, which were wrought with quality control problems, and implemented a remediation plan 2 years ago. But production problems, unbelievably and frustratingly, persist.
In general, the generic injectables market remains fragile. There isn’t much of a profit incentive — generics are expensive to make and inexpensive to buy — for companies to produce the medications. Big Pharma is big businesses, first and foremost, and companies are opting to focus their manufacturing resources on more lucrative brand-name therapeutics.
