GAO Says FDA Doing (Almost) All It Can to Alleviate Drug Shortages

Posted 11 February 2014 By Alexander Gaffney, RAC

The US Government Accountability Office (GAO) has released a follow-up report on the national problem of drug shortages, lauding the US Food and Drug Administration (FDA) for making efforts to alleviate drug shortages.

Background

"The number of drug shortages remains high," begins the report, released on 10 February 2014. While GAO noted significant progress in confronting new drug shortages in 2013 compared to 2012, its data portrayed the stubbornness with which some ongoing shortages have persisted.

The reasons for the shortages are myriad and have been covered by Focus and others at length. They include quality problems, production disruptions, supply disruptions, limited manufacturing capacity, profit margins, gray-market pharmacies and more.

For its part, FDA has been actively trying to alleviate the shortages. So far, it has allowed the import of certain unapproved drugs to ease especially dire shortage situations, worked one-on-one with manufacturers experiencing problems, approved novel manufacturing agreements, and expedited the reviews of substitute medications.

But most important of all, it recently released a proposed rule on drug shortages which would require companies to alert FDA when they expected a drug to experience a shortage, either from manufacturing problems or due to plans to no longer market the drug. While the rule has experienced some pushback from manufacturers and calls for other changes, FDA said it expects the rule to allow it to address shortages even sooner.

Report: FDA has Made Progress

Overall, GAO's report is quite kind to FDA. It notes progress and substantial efforts at nearly every possible juncture.

But with 288 ongoing drug shortages as of 30 June 2013 and 73 new shortages to deal with, what more can FDA be doing?

Unfortunately, not much, the report observes. Most of what FDA can legally do is already being done; most of what it isn't doing isn't legal for it to do. FDA "does not have control over private companies' business decisions," the report states. "For example, FDA is unable to require manufacturers to start producing or continue producing drugs, or to build redundant manufacturing capacity, regardless of the severity of a shortage."

The one area it could be doing more, it goes on to say, is with respect to the data it collects on shortages.

For example, the report says FDA "lacks policies and procedures for its use and management of drug shortage data." Specifically, there are no standard glossary terms for defining shortage terms, the report notes. "This lack of documentation may limit the agency's ability to communicate proper use of the existing and new databases to staff and could also ultimately lead to inconsistencies in the use of the database." Further, there are no ongoing data quality initiatives meant to ensure the accuracy of the data over time.

FDA was advised to do more to develop an information system to understand the causes of shortages and find ways to systematically prevent them.

"This lack of documentation may limit the agency's ability to communicate proper use of the existing and new databases to staff and could also ultimately lead to inconsistencies in the use of the database," the report said.

FDA reportedly agreed with the report's conclusions and is working to implement the recommendations.

The report follows a similar one released by GAO in 2011.

 

GAO Report on Drug Shortages

Share this article:

Categories: US, FDA

Tags: Report, Drug Shortage, Latest News, Drug Shortages, GAO

Regulatory Exchange: Latest Updates From the Community