Continuing Injectable recalls forcing US to look for alternative sources
Hospira has announced yet another recall, this time related to copper particles found in sodium chloride injections that could potentially cause copper toxicity. Hospira, the largest US provider of sterile injectables has invested more than $375mn to upgrade its system, yet it has had to recall products at a rate of once per month so far this year. Contamination appears to be the prevalent issue, whether due to copper or visible particles embedded in the glass. If the issue was isolated to Hospira then the problem could be contained, however, several other companies are also issuing recalls. Just last week Clinical Specialties Inc voluntarily recalled all of its Avastin injections as they were linked to eye infections, and Pallimed recalled several products had particle contamination. Other recent cases include Medprep Consulting recalling drugs over fungus infection and Gilead recalled Vestide due to particle matter contamination. With so many cases so far this year alone there is a worrying trend of poor manufacturing processes in the US.
What can be done?
FDA Commissioner Margaret Hamburg is taking specific aim at the lack of US state laws over the “compounding pharmacies” responsible for producing the injectables. She points out that “some of the operators resist having their records reviewed” and that the current patchwork of state laws are to basic to protect patients from risks associated with the products. That being said, Pharmaceutical MNCs are not waiting for the FDA to combat this shortage in injectable production and have been focusing on buying up FDA-approved manufacturing facilities abroad. In February Mylan purchased Strides Arcolab?s injectable manufacturing plant for $1.6bn and now India-based Claris Life Sciences is being courted by Pfizer and Teva.
The interest in India?s injectable manufacturing facilities is not just driven by poor sterile production issues at home. The increase in the number of injectable-based drug shortages in the US (in 2011 there was 183) is also prompting Pharmaceutical giants to search elsewhere. Over the next months we should expect to see many Pharma MNC?s looking to expand operations in countries with established manufacturing facilities in order to combat the shortfall at home.
– Jonathan Mackinnon