Manufacturing problems in several Pfizer plants are causing shortages of crucial medications used in hospitals, according to a Sunday New York Times report.
Pfizer, the largest manufacturer of injectable drugs in the United States, had “out of control” problems at the plant it acquired from Hospira, an injectable manufacturer, according to the New York Times report. Problems at the plant included not following sterilization processes, cardboard particles in medication, and not sufficiently investigating potentially contaminated batches of medication, according to a February 2017 Food and Drug Administration letter to Pfizer.
One of the drugs affected by Hospira plant malfunctions is Naloxone, the drug that reverses opioid overdoses, according to a June 4 press release from Pfizer. Two lots of the drug were recalled for “potential presence of embedded and loose particulate matter on the syringe plunger.” In 2016, 116 people died each day from opioid overdoses, according to the Department of Health and Human Services.
The shortages are so bad that the FDA is allowing the sale of cracked syringes, accompanied by instructions for properly filtering the medication before it is used, according to the New York Times article. Pfizer plans to spend at least $1.3 billion in the next five years, a Pfizer executive told The New York Times.
“We are completely aware of the essential nature of our portfolio,” Navin Katyal, general manager of Pfizer’s Injectables unit, told The New York Times. (RELATED: Puerto Rico VA Pharmacy Tech May Only Get 2 Years For Stealing $6.75 Million In Insulin)
While other companies are trying to make up for the shortage, there are hurdles to ramping up their production. Basic injectables are costly to make, however, they provide relatively low margins to the producing companies. This leads to a shortage of producers and relatively little investment in facilities for those that still do produce basic injectables.
FDA Commissioner Scott Gottlieb told The New York Times that one possible solution was increasing Medicare reimbursements for the affected drugs, but that is only a short-term solve. “Today it’s one drug, tomorrow is going to be another drug. We’ve got to think of something more holistic and comprehensive,” Gottlieb said.
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