Will Hospira Get A Consent Decree?

Will Hospira Get A Consent Decree?

December 1st, 2011 // 1:29 pm @

As prescription drug shortages abound, one of the manufacturers that has contributed significantly to the problem appears increasingly likely to get hit with a consent decree by the FDA, at least according to one Wall Street analyst, who believes the ongoing manufacturing problems are much worse than anyone previously thought.

In an investor note, RBC Capital Markets analyst Shibani Malhotra believes that the assorted problems will take a minimum of two to three years to resolve. “Most damning is the widespread nature of the violations demonstrating that there may be a more systemic issue that will have to be rectified long term,” she writes. “…A consent decree may be more likely than we previously believed.”

The prediction may not be terribly surprising, given the extent of the issues that Hospira has faced. Last year, the FDA found a host of manufacturing issues at two North Carolina plants, prompting a warning letter and, more recently, 483 inspection reports (read here and here). Many Hospira meds now appear on the FDA shortages list .

After speaking with FDA manufacturing and quality control consultants, and senior execs from other generic injectable makers, Malhotra believes the Hospira violations meet FDA criteria for entering a consent decree. Why? “The nature of violations show numerous, very serious problems,” he writes, adding that Hospira is guilty of repeat violations, specifically at Rocky Mount, which is its largest facility, and the drugmaker is guilty of “similar violations across multiple facilities; perhaps even globally.”

As part of its revised stance on drug safety, the FDA has issued consent decrees recently for other drugmakers, notably Johnson & Johnson, which experienced severe manufacturing problems at its McNeil Consumer Healthcare facilities , and Genzyme, which suffered repeated issues at a key plant .


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