By: Ed Silverman
Over the past decade, there has been a noticeable shortage of prescription drugs containing controlled substances, such as narcotics and stimulants, causing difficulties for both patients and physicians. Doctors have to scramble to find alternatives and, sometimes, patients simply go without treatment. As it so happens, a new report finds the U.S. Drug Enforcement Agency has contributed to the problem.
How is this possible? Well, controlled substances are regulated by DEA, because of the potential for abuse and addiction. And to prevent diversion, the DEA sets quotas that limit the amount that can be produced. The DEA, however, has not effectively managed the quota process and this has contributed to product shortages, according to the U.S. Government Accountability Office.
“Each year, manufacturers apply to [the] DEA for quotas needed to make their drugs,” the GAO writes in its report. 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.”
For its part, the DEA disputed some of the findings and also argued that some of the problems stem from disagreements with the FDA, notably, that the two agencies have differing views on how to define prescription drug shortages.
Concerns about the DEA were raised three years ago by two U.S. Senators – Chuck Grassley (R-Iowa) and Sheldon Whitehouse (D-R.I.) – who wrote the GAO and asked the agency to conduct a study about the extent to which the DEA was contributing to shortages of controlled substances. At the time, there were a rising number of prescription drug shortages.
In its report, the GAO noted that, of the 168 shortages of controlled substances that were reported from January 2001 through June 2013, nearly 70% began between 2008 and 2013. About half of these were pain relievers and most were generics. As we have noted previously, shortages have sometimes been blamed on FDA enforcement of quality-control problems or manufacturers existing markets.
The GAO, however, says the DEA has played a role. The DEA has “weak internal controls” that jeopardize its ability to manage quotas, according to the GAO. As an example, the GAO noted that DEA officials acknowledged quality-control checks are not performed to verify the accuracy of data contained in year-end reports. The GAO estimates that 44% of records in 2011 and 10% of records in 2012 had errors.
What other problems exist? The GAO found the DEA does not have metrics – and data is not monitored – to assess its own performance. Moreover, the DEA lacks protocols, policies and training materials for managing quotas. As a result, the DEA “does not have reasonable assurance that the quotas it sets are in accordance with its requirements.”
There is another issue – the DEA and the FDA are at odds. Although the agencies are required to coordinate when combating shortages of prescription drugs containing controlled substances, the GAO finds they do not have a “sufficiently collaborative relationship.” Notably, the agencies “disagree about what constitutes a shortage,” the GAO writes.
Consider this GAO observation: “DEA officials also said that they do not believe FDA appropriately validates or investigates the shortage information it posts on its website and that posting this information encourages manufacturers to falsely report shortages to obtain additional quota. However, FDA reports that it takes steps to investigate and confirm the shortages on its website.”
As for a fix, the GAO recommends the DEA should institute metrics and policies and perform periodic data checks in order to better manage the quota process. The GAO also suggests the DEA and FDA should “quickly update” a memorandum of understanding, which has not been revised since the 1970s, so that information can be more easily shared and agreed-upon steps taken to combat shortages.
In a brief response, the U.S. Department of Health & Human Services, which oversees the FDA, agreed that the memorandum should be updated and says it is “actively working” with the DEA to do so. The DEA, however, offered a much lengthier response in which the agency neither agreed nor disagreed with the recommendations, but did raise numerous objections to the GAO report.
For instance, the DEA argued that the GAO does not understand how quotas are established and maintained that it has no control over manufacturer decisions. The DEA also disputed how the GAO defined shortages and complained that a draft report noted there was no “causal relationship” between shortages and DEA procedures for establishing quotas. The GAO rebuffed the criticisms.
This is a lengthy report and worth reading, so take a look here.