Obama takes action to address drug shortages

Nov 2 2011

President Barack Obama issued an executive order Monday directing the Food and Drug Administration to, among other steps, speed up reviews of manufacturers' applications to begin or alter production of a drug in potentially short supply.

Los Angeles Times: Obama Tackles Drug Shortages
President Obama is pushing federal regulators to do more to address dangerous shortages of crucial medicines, sidestepping a deadlocked Congress that has not dealt with the problem. In an executive order signed Monday, the president directed the Food and Drug Administration to press drug companies to more quickly report shortages to federal regulators, an early warning that advocates say can help mitigate shortages (Levey, 10/31).

Bloomberg: Obama Calls On FDA To Reduce Drug Shortages, Stop 'Gouging' By Resellers
President Barack Obama directed U.S. regulators to gather information from drugmakers about potential shortages so the government can respond before patients' lives are threatened and help prosecutors head off "price gouging."… The administration said early notice will allow it to work with manufacturers to find alternate sources for medicines, increase production or bring new plants online. The Food and Drug Administration plans to more than double the size of its office dealing with shortages, from five people to 11, said FDA Commissioner Margaret Hamburg (Armstrong and Edney, 10/31).

The Hill: Executive Order Targets Critical Drug Shortages
President Obama took unilateral action Monday to help stem the nation's shortage of lifesaving drugs, a level of personal involvement in health policy not seen since passage of the health care law almost 20 months ago. Tied to the slogan "We can't wait," Obama has been rolling out a series of executive orders to show he's doing everything he can to help the economy despite the impasse in Congress over his jobs bill. The latest presidential action ensured a moment of positive coverage on the health care front after a difficult stretch that saw the demise of the long-term care program and the release of a poll that found most Americans disapproving of the reform law (Pecquet, 10/31).

Politico: White House Targets Prescription Drug Shortages
President Barack Obama signed an executive order today directing the FDA to step up efforts to combat record drug shortages which the White House said "pose a serious and growing threat to public health." "While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent," the order said. "We will marshal all the resources and regulatory power we already have to make sure Americans do not have to leave their pharmacies empty handed," HHS Secretary Kathleen Sebelius said in a conference call with reporters Monday (Norman, 10/31).

National Journal: White House Presses Companies On Drug Shortages
The Obama administration on Monday asked drug companies to give more of a heads-up about drug shortages, pressing Congress to move legislation that would give the Food and Drug Administration more teeth to enforce early warnings and also doubling the small staff of an FDA office that deals with shortages. President Obama signed an executive order asking FDA to work with the Department of Justice to make sure the shortages aren't leading to price gouging (Fox, 10/31).

The Associated Press: New Effort To Reduce Drug Shortages A Small Step
Unprecedented drug shortages are threatening the lives of cancer patients and other seriously ill people, and the Obama administration's plan to tackle them is but a small step toward solving a complex problem. President Barack Obama ordered the Food and Drug Administration on Monday to take new steps to send out early warnings about looming shortages and try to avert them (Neergaard, 10/31).

CNN: Obama Tackles Drug Shortages, Prices
President Barack Obama signed an executive order Monday designed to help reduce a growing number of prescription drug shortages while protecting patients from possible pharmaceutical industry price gouging. Among other things, the order requires the Food and Drug Administration to increase its reporting of possible shortages of certain prescription drugs, while also speeding up regulatory reviews of new drug manufacturing sites, drug suppliers and manufacturing changes. The Justice Department will be tasked with examining whether specific drug shortages are tied to an intentional stockpiling of medications designed to raise prices (Silverleib, 10/31).

NPR's SHOTS blog: Obama Tackles Rx Drug Shortages
With no immediate prospect of a congressional fix, the president is extending his recent penchant for executive orders to the drug shortage problem. ... The Food and Drug Administration will broaden its requirements and voluntary requests for drug manufacturers to report potential supply problems. The FDA will speed up reviews of manufacturers' applications to begin or alter production of a drug in potentially short supply. The FDA will tell the Justice Department about possible instances of collusion or price gouging among drug distributors taking advantage of shortages (Knox, 10/31). 

Minnesota Public Radio: Minn. Doctors Happy With Obama Action On Drug Shortage
Dr. Edward Greeno, medical director at the Masonic Cancer Clinic at the University of Minnesota, says the president's executive order will shed light on the complex reasons behind persistent drug shortages. ... But Greeno is also realistic about the challenges. It may not be possible for the FDA to get much advance notice from drug companies when they have a problem with a drug, because most of the shortages appear to be unpredictable, he says (Benson, 10/31).