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Friday, March 13, 2015

DEA Efforts Lead to Drug Shortages

In the midst of a prescription drug epidemic crippling America, the last thing you might think you’d hear is that there is a prescription drug shortage. However, a new report conducted by the Government Accountability Office (GAO), found that there is a shortage of prescription narcotics and stimulants, The Wall Street Journal reports. The cause of the shortage is the result of the Drug Enforcement Administration (DEA) setting quotas on drug production.

The DEA, in an attempt to prevent diversion of controlled substances, sets quotas that place ceilings on the amount of certain substances that can be made available in the United States. While this sounds important, the GAO report found that the DEA hasn’t managed the quota process in an effective manner, resulting in drug shortages, according to the article.

“Each year, manufacturers apply to [the] DEA for quotas needed to make their drugs,” wrote the GAO in its report. But, the “DEA, however, has not responded to [the drug makers] within the timeframes required by its regulations for any year from 2001 through 2014… Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs.”

Due to “weak internal controls,” making it challenging to manage quotas, the GAO report found that the lack of quality-control checks to help determine the accuracy of year-end reports has resulted in drug shortages. The GAO recommended the DEA and Food and Drug Administration (FDA) update an agreement allowing the two agencies to work better together to reduce the shortages. The DEA should also perform periodic data checks, in order to improve the quota process.

The DEA responded to the GAO report, stating that the GAO is not familiar with how quotas are determined, according to the article. They said the Agency has no control over drug manufacturers’ decisions and that there is not a “causal relationship” between shortages and establishing quota procedures.

Clearly, most users of prescription narcotics do not abuse the drugs; preventing abuse should not result in lack of availability.

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