US DEA drug ingredient quota review failings increasing shortages says GAO

By Gareth Macdonald contact

- Last updated on GMT

DEA mismanagment of API quota reviews making shortages worse
DEA mismanagment of API quota reviews making shortages worse

Related tags: Controlled substances act

The DEA's mismanagement of the controlled substance API quota system and its poor relationship with the FDA have exacerbated drug shortages according to the US GAO.

The GAO made the comments in a report was last week​, suggesting the increase in shortages was partly because the DEA “has not effectively administered the quota process that limits the amount of controlled substances available for use in the US.”

The distribution of narcotic active pharmaceutical ingredients (API) is controlled by the DEA using a quota system. The idea is to prevent stockpiling by limiting manufacturers’ production of the actives and only allowing drugmakers to buy them limited quantities.

The problem with the system, according to the GAO, is that the DEA “has not responded to them [the applications] within the time frames required by its regulations for any year from 2001 through 2014​” which it says has had a direct impact on the availability of some drugs.

The GAO also raised concerns about the management of data filed by API firms and drugmakers, suggesting the DEA “lacks critical management information because it does not have performance measures related to setting quotas, nor does it monitor data to assess its performance​.”

Disagreement

Another major criticism is the lack of interaction between the DEA and the Food and Drug Administration (FDA), which the GAO said create confusion.

Despite statutory provisions requiring DEA and FDA to coordinate certain efforts to address shortages of drugs containing controlled substances, the agencies have not established a sufficiently collaborative relationship​.”

This lack of collaboration runs from failure to agree what constitute a shortage to DEA officials’ belief the FDA encourages manufacturers to falsely report shortages to obtain additional quota by failing to investigate announcements posted on its site.

The GAO said this lack of collaboration and mistrust means the “DEA and FDA cannot effectively act to prevent or alleviate shortages,” citing the agencies’ failure to update a memorandum of understanding originally agreed in 1970 as further evidence of their poor relationship.

DEA denial

The DEA said in response that there is no link between its quota process and drug shortages. It also said the methodology and data analysis in GAO’s review was flawed. 

The agency acknowledged that it had missed quota review timelines, which it said was due to staffing shortages.

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