Drugs can end up on the FDA shortage list for many reasons, with manufacturing problems and recalls often being the culprit. But a new report says that for more than a decade, poor management by the Drug Enforcement Agency and a touchy relationship between the DEA and FDA have been at the heart of many shortages of controlled substances.
The DEA "has not effectively administered the quota process that limits the amount of controlled substances available for use in the United States," failing each year to follow federal regulations for telling drugmakers what their limits of each drug will be, the report from the federal Government Accountability Office (GAO) said.
The situation has gotten increasingly worse. Of the 168 shortages of controlled substances reported from January 2001 through June 2013, nearly 70% began after 2007, lasting a year on average and affecting patient care. The report says DEA record-keeping has been rife with errors. In its response, the DEA blames the delays on a lack of manpower, but the GAO says the DEA does not measure its results each year so has no way of knowing how it is doing.
The GAO also faults a lack of cooperation between the DEA and the FDA for exacerbating the problem, saying the two can't even agree on what constitutes a shortage. It points to the fact that the DEA doesn't trust the FDA. It suggests that drugmakers often lie about shortage information to try to get a higher quota and that the FDA doesn't "validate" the info to see if it is true, an accusation the FDA refutes. The report also said the 40-year-old memorandum of understanding that sets out how the two agencies should work together is badly in need of updating, something the agencies have been working on for two years.
For its part, the DEA takes issue with the 80-page report and the way the GAO collected its data, defending its performance and pointing out how its definition of a shortage is different than that of the FDA. If a branded pain drug is unavailable but its generic counterpart is, for example, the DEA does not consider that a shortage. It said the GAO's failures "lead to an analysis that unfairly linked the quota process to diminished patient care."
As for the FDA, it says it agrees that the memorandum of understanding needs to be updated and is working to get that done.
Drugmakers for their part have often made the DEA the culprit in shortages, saying that its foot-dragging has caused or deepened shortages of their products. Japan's Eisai even filed a lawsuit against the DEA a couple of years ago to try to force it to act on the seizure drug Fycompa, which had gone unscheduled for a year after it was approved by the FDA. A court denied the action.
- heres' the report