FDA is disputing a GAO account of ongoing drug shortages, and argued during a congressional hearing they are plateauing, rather than increasing.

While the Government Accountability Office counted each specific product that had undergone a shortage, FDA told the House Energy and Commerce Health Subcommittee that it deemed a shortage to be ongoing only if the therapy remained unavailable to patients in any form.

Douglas Throckmorton, Center for Drug Evaluation and Research deputy director for regulatory programs, said after the Feb. 10 subcommittee hearing that the agency’s definition indicated ongoing shortages, those that stretch year to year, are “flattening.”

FDA said in response to the GAO report, released Feb. 10, that it is tracking 97 ongoing shortages now and since 2011, that number has “remained consistent” at about 100.

“We’re looking at the totality of the data, the availability of a given therapy, not an individual product,” Throckmorton told the subcommittee. “We believe fundamentally ours reflect the availability of a therapy for the patient.”

GAO found that while the number of new shortages reported decreased in 2012 after five years of increases, the number of ongoing shortages continued to grow.

The number of ongoing shortages increased from 40 in 2007 to 261 in 2012 and 288 as of June 30, 2013, GAO said.

In its response to the report, the Department of Health and Human Services said GAO may be overstating the ongoing shortage problem because its methods of measurement did not account for manufacturers ramping up production to meet demand when a competitor stops making the product.

HHS wrote that “counting any shortage where not all National Drug Codes have been restored by all manufacturers as an ongoing shortage” overstates their persistence.

An FDA spokesperson said after the hearing that the agency does not think GAO’s approach is clinically meaningful.

Shortage Trend Analysis Necessary, GAO Says

FDA plans to develop a more comprehensive database of information to help it better track shortages, Throckmorton’s written testimony said.

But GAO said FDA does not have the policies in place to manage the shortage data it already collects. It should be using the data to identify and predict shortage risks, according to the report.

Marcia Crosse, GAO director for health care, told the committee that FDA must not treat a shortage as a one-time event.

“We think it’s important for the agency to have good information because they need to be able to look at this more broadly… to be able to measure whether or not they are putting the right steps in place and having the kind of impact to improve the situation, rather than treating these as each individual kinds of situations that have to uniquely be solved,” she said.

Crosse’s written testimony said that GAO found FDA “uses data on an ad hoc basis to respond to specific shortages as opposed to using data to identify trends or patterns that may help it predict and possibly prevent shortages.”

“FDA is missing opportunities to use the data proactively to enhance the agency’s ability to prevent and mitigate drug shortages,” Crosse said.

Throckmorton said after the hearing that FDA is thinking about long-term shortage trends, but they are separate from the activities required when a shortage emerges.

Early Warning Extremely Helpful

Many of the drugs most prone to shortages are sterile injectable products. An effort is ongoing to collect generic drug production data and use it to predict potential shortages, but it has not launched yet ([A#00130708013]).

FDA has made progress in gaining control of the shortage problem and Throckmorton indicated that additional congressional authority may not be necessary.

Partially responsible for the agency’s success is the early notification it now must receive from many manufacturers once they know a shortage is coming.

Throckmorton said in written testimony that in 2013, the agency helped prevent 170 shortages, as well as 282 shortages in 2012 and 195 shortages in 2011. He told the subcommittee the notification provision was “enormously helpful” and that it was “hard … to overstate that.”

The agency recently issued a proposed rule that would require at least six months notification of a known production disruption, the latest in a string of moves to gain more information about potential shortages ([A#14131031007]).

Notifications have increased since President Obama issued an executive order encouraging more advanced warnings in 2011, Throckmorton said in written testimony.

The order did not provide any new authority, but did allow FDA to grow its shortage staff Also see "Obama's Drug Shortage Efforts Focus On Personnel, Persuasion" - Pink Sheet, 31 October, 2011..

Drug Shortage Analysis Puts FDA At Loggerheads With GAO

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