WASHINGTON -- The FDA flexed newly granted regulatory muscle on Thursday in efforts to resolve drug shortages, releasing a strategic plan and a proposed rule.

The strategic plan, mandated by Congress last summer, aims to prevent shortages in the long term by improving the agency's response to imminent shortages and addressing the underlying causes of them.

The FDA also issued a proposed rule expanding its early notification requirement to biologics and implementing the expanded notification requirements called for under the FDA Safety and Innovation Act (FDASIA), which became law in July 2012.

"This whole effort is about patients, their appropriate care, and our ongoing commitment to make sure we do everything in our power to get them the medicines they need when they need them," FDA Commissioner Margaret Hamburg, MD, said in a call with reporters Thursday.

One arm of the strategic plan hinges on improving the FDA's coordination of and communication about shortages. Goals call for creating a mobile smartphone application to send information about drug shortages and revamping interactions between the various FDA offices that handle shortages.

The FDA solicited feedback following a Federal Register notice and used its own experiences to develop the strategic plan.

"As part of this work, we also recognized that we need to improve our communications both between groups within the agency as well as communications with the public and healthcare providers about drug shortages," said Douglas Throckmorton, MD, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research.

The plan also seeks to develop ways to better prevent shortages from occurring in the more distant future. Strategies include:

Identifying ways the FDA can incentivize manufacturing and product quality

Developing approaches to identify early warning signals for manufacturing and quality problems

Working to further develop issues related to shortages, including whether a Qualified Manufacturing Partner Program would be feasible

"Although FDA cannot directly affect many of the business and economic decisions that contribute to drug shortages, FDA is well-positioned to play a significant role as manufacturers work to restore lost production of life-saving medications," the strategic plan stated.

Throckmorton said the FDA is eyeing the creation an office of quality within CDER, since a lack of quality often leads to drug recalls and shortages. The agency is also examining whether or not to require a buildup of drug supply before creating a manufacturing change and other mandates.

The proposed rule released Thursday by the FDA formalizes the conditions manufacturers must alert the FDA of which may lead to a shortage or disruption in supply of a critical drug.

The heads up to the FDA allows the agency to work with drugmakers to investigate issues leading to a disruption, identify other ways to make up for the shortfall, or expedite inspections and applications to mitigate a shortage.

Following an Executive Order issued by President Obama in late October 2011, manufacturers were asked to voluntarily notify the FDA of changes in manufacturing habits that could create a shortage or disruption. FDASIA made that voluntary notification into a mandate.

Thursday's proposed rule also extends that early notification requirement to biologics.

The FDA said the early notifications helped prevent 195 drug shortages in 2011 and 282 last year, and have led to reducing the number of shortages overall.

The University of Utah Drug Information Service has tracked just 86 new shortages through July 31 of this year, down from 204 in all of last year, 267 in 2011, and 211 in 2010, it said earlier this summer. However, the number of active shortages as of the end of July was 302 -- roughly what it has been since the third quarter of 2012.