Obama Executive Order Addresses Drug Shortages

Louder drumbeat for early warning by manufacturers of potential shortages.

To address the growing problem of drug shortages, President Barack Obama yesterday signed an executive order that directs FDA to broaden reporting of potential shortages, speed up regulatory reviews that can help prevent or respond to shortages, and work with the U.S. Department of Justice (DOJ) to examine whether potential shortages have led to illegal price gouging or stockpiling.

Also announced yesterday was Obama’s backing of bipartisan legislation pending in the U.S. House of Representatives (H.R. 2245) and the U.S. Senate (S. 296) that would require early warning by manufacturers of potential shortages. In addition, the Obama administration sent a letter to drug manufacturers reminding them of their legal responsibility to report discontinuations under current law and encouraging them to voluntarily warn FDA about potential shortages.

The number of reported drug shortages annually has tripled from 61 in 2005 to 178 in 2010, according to a White House fact sheet. This year, voluntary early warning by drug manufacturers allowed FDA to prevent 99 drug shortages. Under current law, drug manufacturers are only required to notify FDA of discontinuations in a critical drug made by one company.

“We can’t stand by” and watch Americans go without medications they depend on, Kathleen Sebelius, HHS Secretary, told reporters on a conference call yesterday.

Under the executive order, Obama directed FDA to use all available administrative ways under current law to require drug manufacturers to provide early warning of manufacturing interruptions that could lead to shortages. Under current law, there’s “limited reporting” of potential shortages and “underreporting,” FDA Commissioner Margaret Hamburg, MD, said on the call.

Also, Obama directed FDA to take steps to expand current efforts to speed up its regulatory reviews that would help to avoid or mitigate existing or potential shortages. To handle the increased workload as a result of increased early notification by manufacturers after the executive order, FDA plans to more than double staff in the agency’s Drug Shortage Program from 5 to 11 people, Hamburg said.

In addition, Obama directed FDA to communicate to DOJ “any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices.” DOJ will then determine whether the activities are legal, and work with other state and federal agencies to enforce the law as appropriate.

During the call, pharmacist Bonnie Frawley of Brigham and Women’s Hospital in Boston told reporters that no patient is spared from the implications of drug shortages and that health care providers hope to get better information earlier so they can make the best plans possible for patients.

Frawley described a looming shortage of I.V. fentanyl, which treats pain in hospital patients quickly: “It is quite possible we will not be able to obtain fentanyl by the end of the year.” She noted that health care providers may be unfamiliar with alternatives to the drug for which there’s a shortage.

Also yesterday, the U.S. Department of Health and Human Services (HHS) released a report assessing the underlying economic factors leading to shortages, and FDA released a report on the agency’s approach to shortages.

For updates on current drug shortages and additional information, go to FDA’s website. The American Society of Health-System Pharmacists website also has information and resources on shortages.

Related resource on www.pharmacist.com

Posted by Diana Yap (dyap@aphanet.org)

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