President Obama, FDA employ new strategies against drug shortages

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Jan 01, 2012

NATIONAL REPORT — Atropine sulfate has just been added to the list of medically necessary veterinary drugs in short supply, reports the U.S. Food and Drug Administration (FDA).

Manufactured by Sparhawk Laboratories, the drug treats insecticide poisonings. The shortage has been cause by manufacturing delays.

Bert Hughes, president and chief executive officer of Sparhawk says the shortage came after FDA notified the company it would now consider atropine sulfate a new animal drug. The new classification requires Sparhawk to obtain a medically necessary waiver to import the drug's active ingredient.

The process to complete the waiver was lengthy, but Hughes says FDA helped the company through the process. He is now working with FDA on a new waiver for another importation of the drug's active ingredient so the company can manufacture additional supplies.

"I think as long as its in short supply, it appears to me that we can request the medically necessary waiver and FDA will work with us," Hughes explains.

FDA's efforts to help Sparhawk mitigate the shortage came on the heels of a new executive order by President Barack Obama targeting human-drug shortages.

Drug shortages tripled from 61 in 2005 to 178 in 2010, FDA says, with sterile injectables making up the bulk of those shortages (80 percent) in the human medical market. Oncology drugs (28 percent) were next, followed by antibiotics (13 percent) and electrolyte/nutritional drugs (11 percent). FDA helped prevent 38 drug shortages in 2010 and 99 so far in 2011, according to the agency's review of medical product shortages.

In an executive order signed Oct. 31, Obama directs FDA to take more action in preventing and reducing drug shortages and protecting consumers from price gouging.

Previously, FDA could only require drug manufacturers to disclose critical drug discontinuations when the drug is available through a sole manufacturer. But the President's executive order allows FDA to take additional steps, like requiring drug makers to provide more notice of manufacturing discontinuances or other actions that could lead to shortages. The order also expands FDA's ability to review new manufacturing sites, drug suppliers and manufacturing changes to prevent shortages.

In addition to the executive order, the Obama administration also sent a letter to drug manufacturers reminding them of their responsibility to report discontinuations of certain drugs to FDA and encouraging them to voluntarily disclose shortages to FDA in cases where disclosure is not required by law. Obama also increased staffing resources for FDA's Drug Shortages Program and has thrown support behind pending bipartisan legislation that would require all prescription drug shortages to be disclosed and give FDA new enforcement authority.