The 2011 shortage crisis and the executive order

FDA counted 251 new drug shortages in 2011. No year before or since has come close. In its report to Congress for 2025¹, the agency still calls 2011 "the height of the drug shortage crisis" and notes that new shortages it tracked had quadrupled from about 61 in 2005.

On Oct. 31, 2011, with that count still climbing, the White House issued Executive Order 13588², "Reducing Prescription Drug Shortages." It ran two pages in the Federal Register and contained three operative instructions to FDA. Within nine months Congress had written its central idea, mandatory advance warning from manufacturers, into federal law.

Most of the rules that govern shortage reporting today trace back to that year. This history lays out what the 2011 numbers showed, what the order required, what FDA did in the weeks after, and how the episode led to the 2012 statute explained in our companion piece on FDASIA and early notice of shortages.

How the count climbed

Two sets of numbers were in circulation then, and both are still cited. FDA counts shortages it confirms at the national level. The University of Utah Drug Information Service, which runs the shortage service ASHP publishes, defines a shortage "from the perspective of a health care organization," as any supply problem that changes how a pharmacy prepares a product or pushes prescribers to an alternative, the 2011 HHS brief⁵ explained in an appendix. Our explainer on why FDA and ASHP counts differ covers the methods.

Sources: FDA figures from the CY 2025 report to Congress¹, the 2011 HHS economic analysis⁵ (2010) and the CY 2015 report¹¹ (2012 to 2014). University of Utah figures for 2004, 2005 and 2010 from the same HHS brief; 2011 to 2014 from a chart presented at a 2022 FDA workshop⁶.

Utah's 2011 total topped its previous record, 211 in 2010, according to a January 2012 report⁷ from the Regulatory Affairs Professionals Society. By either count, 2011 was the peak.

What was running short

Sterile injectables, the drugs hospitals give by IV, were at the center of it. An October 2011 issue brief⁵ from the HHS Office of the Assistant Secretary for Planning and Evaluation reported that 74% of 2010 shortages involved sterile injectable drugs, and that FDA was "continuing to see new sterile injectable drug shortages" in 2011, including cancer drugs, surgical anesthetics, emergency medicines and electrolytes for IV feeding.

ASPE's brief also offered an economic explanation. Sterile injectable makers had taken on many more products in a short period, partly because of "an unusually high rate of patent expirations" among injectable cancer drugs from 2008 through 2010, without adding plants. The market was concentrated: in a sample of 33 generic injectable cancer drugs, at least 90% of 2010 unit sales for 28 of them came from three or fewer manufacturers. At high capacity use, the brief said, any quality problem or ingredient delay "can lead to cascading and persistent shortages." Our piece on why sterile injectables dominate shortage lists follows that thread forward.

Hospitals were absorbing the cost, in ways our piece on how hospitals manage drug shortages describes. The ASPE brief cited a June 2011 survey of 353 hospital pharmacy directors that put the annual labor cost of managing shortages at about $216 million nationwide, and a separate hospital survey finding that almost all of 820 responding hospitals had faced at least one shortage in the prior six months. FDA's own later tally of 2012 disruptions found that 66% stemmed from quality problems, split between product-specific failures and broader plant remediation, according to its 2013 strategic plan⁴.

What the executive order said

Its opening section made a finding: "the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010." It said FDA had prevented 137 shortages in 2010 and 2011 by working with manufacturers, and that "despite these successes, however, the problem of drug shortages has continued to grow."

Its three instructions, in the Federal Register text², were these. Section 2 told FDA to use "all appropriate administrative tools" to require "adequate advance notice of manufacturing discontinuances" for drugs that are life-supporting, life-sustaining or prevent debilitating disease. Section 3 told the agency to expand expedited review of new suppliers, sites and manufacturing changes when that would head off a shortage. Section 4 told FDA to refer to the Justice Department any findings that market participants were stockpiling scarce drugs or selling them "at exorbitant prices." The White House archive³ still carries the order.

An order could not create a new legal duty for manufacturers. At the time, section 506C of the Food, Drug, and Cosmetic Act required notice only from sole manufacturers, only for discontinuances, and only for certain approved drugs, the strategic plan⁴ later explained. FDA had to work inside that frame until Congress acted.

What FDA did in the following weeks

Reporting changed fast. FDA's 2013 strategic plan⁴ said notifications from manufacturers rose six-fold after the order, "from 10 notifications per month prior to the Executive Order to an average of 60 per month since." The staff assigned to shortages grew from four employees in 2011 to 11 in 2013. FDA said it helped prevent close to 200 shortages in 2011 and more than 280 in 2012, and new shortages fell to 117 in 2012.

Clearing the backlog took longer. That plan noted that more than 300 shortages were still active at the end of 2012, because "shortages typically continue for extended amounts of time."

From an order to a statute

Title X of the Food and Drug Administration Safety and Innovation Act¹⁰, signed July 9, 2012, turned the order's main request into law and added more:

• Section 1001 rewrote section 506C so that all manufacturers of covered prescription drugs, approved or not, must report both permanent discontinuances and interruptions.
• Section 1002 required an annual report to Congress on shortages.
• Section 1003 created a task force and a strategic plan, which became the October 2013 document cited above.
• Section 1004 required FDA to keep a public shortage list, now section 506E.
• Sections 1005 through 1008 dealt with controlled-substance quotas, a Justice Department report, hospital repackaging of drugs in shortage, and a study of shortages.

FDA's final rule implementing the new 506C¹² followed on July 8, 2015, taking effect Sept. 8, 2015. It superseded the 2011 interim rule.

What 2011 left behind

New shortages have since fallen steeply. FDA counted four in 2025, the lowest in a decade, and said it helped prevent 330 that year, according to the CY 2025 report¹. Long-running ones remain: FDA identified 93 ongoing shortages at the end of 2025, and said they "often persist due to market conditions," including "lack of incentives for firms to manufacture older, less profitable products." Several drugs on FDA's current list were first posted in early 2012, as our account of the longest-running shortages shows. The economics the 2011 HHS brief described are still the subject of our piece on why drug shortages happen. FDA's next annual report, covering 2026, is due to Congress by March 31, 2027.