DEA Quotas – Greater Transparency and Predictability Needed

January 3, 2012

By James R. Phelps

Over the New Year's Day weekend, The New York Times reported on the shortage of ADHD drugs, with this quote:  “‘We have reached out to the D.E.A. and told them that there are shortage issues,’ said Valerie Jensen, associate director of the F.D.A.’s drug shortage program. ‘But the quota issues are outside of our area of responsibility.’”  The DEA responded, contending that there is plenty of supply, and the manufacturers are to blame for the shortages, saying, according to the Times: “… any supply disruptions (are attributable) to decisions made by manufacturers.”  Sorting out the “blame” will depend upon understanding the process by which manufacturers are able to work within the quota system.

Production of the supply of Schedule II drugs is controlled by DEA through quotas granted by the agency, on a yearly basis.  Manufacturers must calibrate production based upon DEA’s decision concerning how much they may produce (i.e., within the quota allocations granted by DEA based on the company’s submissions to the agency).  In order for the system to work properly, DEA should process quota requests in a predictable and timely manner.  Further, the agency should articulate clearly the bases upon which it makes quota allocations.   

It would be of interest for the public to be provided the usual timelines for quota requests and DEA responses.  Does DEA routinely grant quota allocations in time for sensible manufacturing decisions?  A public expression of the criteria that DEA uses in setting quotas would also help to clarify the situation.  The manufacturers, dependent upon DEA for quotas, might not be the best source to expose any difficulties that exist, so perhaps congressional oversight is warranted.

The controversy, with its dreadful health implications, brings to light – again – the tension that exists between the medical regulation and the police regulation of those medicines that might be abused.  Most would agree that patient access should be the priority; patients who require these medicines should receive the same respect and attention as any other medical patient.  Certainly the policing of drugs through quotas should be done in an efficient, thoughtful manner.