Regulatory Focus™ > News Articles > FDA to Once Again Allow Import of Unapproved Drugs to Solve Shortages

FDA to Once Again Allow Import of Unapproved Drugs to Solve Shortages

Posted 29 May 2013 | By Alexander Gaffney, RAC

Responding quickly to congressional pressure and the needs of critically ill neonates, the US Food and Drug Administration (FDA) today announced that it would allow the import of several types of total parenteral nutrition (TPN) drugs now in short supply, exercising yet another display of its enforcement discretion when it comes to drug shortages.

Background

On 6 May 2013, a group of 13 senators signed a letter to FDA Commissioner Margaret Hamburg demanding the agency's attention and action in regards to ongoing shortages of TPN products.

"The ongoing shortage of these products, including sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride, zinc, trace elements, and several others, is deeply concerning," they wrote. "Without steady doses of total parenteral nutrition, critically ill infants are at risk of serious negative health outcomes such as painful skin lesions, poor bone health, or vitamin deficiencies."

They said they realized at least one manufacturer was already working with the agency to resolve quality-related issues, but asked that the agency do everything in its power to return the products to market as quickly as possible.

New Developments

That plea evidently left FDA looking at its playbook for addressing drug shortages, selecting one used twice in recent memory: selective imports of unapproved drugs. In the agency's 29 May 2013 announcement, it said it would permit Fresenius Kabi to import "trace elements and phosphate injections" from the company's Norway plant to resolve shortages.

That same strategy was used in 2012 to allow the import of Lipodox (doxirubicin) from Indian-based Sun Pharmaceuticals and methotrexate from a Canadian subsidiary of Hospira.

As with the two aforementioned cases, the products being imported by Fresenius Kabi are not yet approved by FDA, though FDA has shown a willingness (e.g. Sun's Lipodox) to approve those products in an expedited fashion if shortages continue for a long enough time. FDA said that its exercise of enforcement discretion-in this case, deciding not allow a company to market a drug without first having received approval-was only "temporary."

In a statement to Focus, FDA said it had worked to evaluate Fresenius' TPN products "to ensure that it is of adequate quality and that the drug does not pose undue risks for US patients."

FDA said it was continuing to work with American Regent/Luitpold, a TPN manufacturer that shut down in late 2012 due to quality issues, to prioritize the manufacture of critical drugs as the plant comes back online.


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Tags: Shortage

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