Regulatory Focus™ > News Articles > FDA Moves to Standardize Labeling of Drugs Imported to Ease Shortages

FDA Moves to Standardize Labeling of Drugs Imported to Ease Shortages

Posted 08 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) appears to be institutionalizing one of the methods it uses to combat drug shortages, creating a new category for pharmaceutical products imported into the country to ease shortages without having received conventional FDA approval.

In an 8 May posting on its website, FDA said it was creating a new category and corresponding code for its list of acceptable terms to be used within a structured product label (SPL)-FDA's standardized mechanism for defining and exchanging product information.

The new category, "unapproved drug for use in drug shortage - C101533," appears to be applicable to a small number of products FDA has been allowing to be imported to ease drug shortages.

Regulatory Focus reported in March that FDA is allowing unapproved methotrexate into the US to ease drug shortages. The Canadian-sourced methotrexate, sourced from manufacturer Hospira, reportedly had the same active pharmaceutical ingredient and concentration as the US-approved version does.

That move followed on in late February in which FDA said it was allowing supplies of Lipodox, a substitute for doxorubicin, to be imported into the US from an approved supplier in India.

Both of those decisions, which relied on what FDA referred to as "enforcement discretion" on the part of the agency, came under fire in late March 2012 when US District Court Judge Richard Leon blasted FDA's use of enforcement discretion, calling it "utterly disappointing" and a masquerading "callous indifference [to] health consequences."

That case, however, dealt with the use of enforcement discretion to allow the import of sodium thiopental, which is among those used in a drug cocktail to execute prisoners.

FDA's shift towards institutionalizing that area of enforcement discretion is nevertheless notable, particularly as it signals the tactic is likely to be continually used in the future.


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