jueves, 30 de junio de 2016

FDA Law Blog: GAO Releases Report Recommending that the DEA Take Additional Actions to Address Prior GAO Recommendations

FDA Law Blog: GAO Releases Report Recommending that the DEA Take Additional Actions to Address Prior GAO Recommendations

Posted: 29 Jun 2016 05:00 AM PDT
By Karla L. Palmer –

The Government Accountability Office (GAO) issued three reports during 2015 making eleven recommendations to the Drug Enforcement Administration (DEA) to more effectively perform their functions under the Controlled Substances Act (CSA) and DEA’s implementing regulations (see previous posts here and here).  GAO now reports that, as of June 2016, DEA has taken actions to address some of the recommendations, but has fully implemented just two of them.  See the entire 26-page report here.

In brief, GAO reported in February 2015 that DEA had not effectively administered the quota process, and that DEA and FDA had failed to establish a sufficiently collaborative relationship to address shortages of drugs containing controlled substances subject to quotas.  DEA has taken some actions to address GAO’s seven recommendations concerning administration of the quota process including finalizing an information sharing agreement with FDA addressing drug shortages, and strengthening internal controls regarding implementation of the quota system.  However, DEA has failed to address fully GAO’s five other recommendations from GAO’s February 2015 Report regarding more effective implementation of the DEA quota process.

In June 2015, GAO reported that DEA registrants were not aware of resources and other information available to them to enhance regulatory compliance and better understand their obligations as DEA registrants.  GAO recommended that DEA take three actions to increase registrants’ awareness and improve information flow.  GAO reports that DEA has made some strides in addressing GAO’s recommendations including developing web-based training and updating the Pharmacist’s Manual to reflect new regulations (which to our knowledge has not yet been published).  However, because DEA did not mention plans to develop and distribute additional guidance for distributors or pharmacies, GAO reported that DEA has not fully implemented its recommendations.

Specifically with respect to drug distributors, DEA had “raised concerns” about GAO’s recommendation to solicit input from distributors concerning suspicious order reporting and monitoring.  DEA stated that, short of providing arbitrary thresholds to distributors, “it cannot provide more specific suspicious orders guidance because the variables that indicate a suspicious order differ among distributors and their customers.”

GAO states that in April 2016, DEA provided information about ongoing efforts to educate distributors about their roles and responsibilities for monitoring and reporting suspicious orders (e.g., DEA’s Distributors’ Conferences) and plans for additional yearly distributor training.  DEA “did not mention” plans to develop and distribute additional guidance for distributors.  GAO believes that a guidance document like DEA’s Pharmacist and Practitioner Manuals could assist distributors in understanding and meeting their obligations under the CSA.  Interestingly, GAO stated that although DEA may not be able to provide guidance that will definitively answer the question of what constitutes a suspicious order (notwithstanding significant recent litigation at the DC Circuit on this precise issue) or offer advice about which customers to ship to, DEA could, for example, provide guidance around best practices in developing suspicious orders monitoring systems.  Industry would likely welcome such guidance, so long as DEA does not, in turn, use it as a roadmap in litigation against those same distributors based on non-compliance.  Finally, GAO noted that in the absence of clear guidance from DEA, GAO’s  survey data reveals that many distributors are setting thresholds on the amount of certain controlled substances that can be ordered by their customers (i.e., pharmacies and practitioners), “which can negatively impact pharmacies and ultimately patients’ access.” GAO plans to continue to monitor the agency’s efforts in this area, and thus the recommendation remains open.

Lastly, in September 2015, GAO reported that DEA’s confidential informant policies were not consistent with certain provisions of the Attorney General’s Guidelines.  GAO asserts that DEA failed to address the requirement to provide the informant with written instructions about authorized illegal activity and the requirement of obtaining a signed acknowledgment from the informant.  GAO recommended DEA update these policies and processes.  DEA expects to complete revisions this summer, but until finalized, GAO noted that this recommendation also remains open.

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