“the agency does not concur”



Second federal report critical of DEA actions with pharmacies

62% of pharmacies are facing quotas set by wholesalers.

35% of doctors had their prescriptions denied or delayed.

The Government Accountability Office (GAO) report is for a time frame ending in June 2013, so I would think that 2 years later, these statistics have increased.  My educated guess is that 85% of pharmacies have quotas set by wholesalers, with the remaining 15% mainly consisting of hospitals.  And I would guess that more like 50% of doctors have had their prescriptions denied or delayed, but keep in mind that these restrictions are mostly for pain doctors, and they’re a small percentage of all doctors that prescribe certain medications targeted by the DEA.

Click to access 668252.pdf

Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved

February 2015

Shortages of prescription drugs containing controlled substances have increased sharply in recent years; of the 168 shortages reported from January 2001 through June 2013, nearly 70 percent began after 2007. Such shortages lasted for nearly a year, on average. Additionally, many shortages involved generic pain relievers and drugs where there was only one manufacturer…

For example, DEA and FDA disagree about what constitutes a shortage. 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.

Is the DEA showing signs of paranoia?

However, FDA reports that it takes steps to investigate and confirm the shortages on its website. Given such barriers to coordination, DEA and FDA cannot effectively act to prevent or alleviate shortages…

Page 1

February 2, 2015

The Honorable Charles E. Grassley
Committee on the Judiciary
United States Senate
The Honorable Sheldon Whitehouse
Ranking Member
Subcommittee on Crime and Terrorism
Committee on the Judiciary
United States Senate

In the last decade, shortages of prescription drugs have increased nationwide, preventing providers and patients from accessing medications that are essential for treatment. Some shortages involve drugs that contain controlled substances, such as narcotics, stimulants, and sedatives, which play an important role in health care…


(July 28, 2015) DEA can improve communications with pharmacists, manufacturers, says GAO

A report released by the Government Accountability Office on Monday concluded that the lack of effective communications between DEA and both chain pharmacy headquarters and pharmaceutical distributors has affected legitimate access to analgesics. Both community pharmacies and distributors still request improved guidance and a greater degree of interaction with DEA, though the agency does not concur, the report noted…

GAO’s survey results also showed that more than 50% of DEA registrants have changed certain business practices as a result of DEA enforcement actions or the business climate these actions may have created. Many individual pharmacies (52 of 84) and community pharmacy corporate offices (18 of 29) reported that these stricter limits have limited, to a “great” or “moderate extent,” their ability to supply drugs to those with legitimate needs.

4 thoughts on ““the agency does not concur”

  1. I’m glad to see that the problems of pain patients getting their prescriptions filled is getting some attention from government agencies. That’s where many of the rules are coming from (or drive behind them), so that’s where there’s actually a possibility of changes being made.

    Liked by 1 person

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