jueves, 23 de febrero de 2017

FDA Law Blog: DEA Administrative Decisions Update: (Un)official Notice Revisited

FDA Law Blog: DEA Administrative Decisions Update: (Un)official Notice Revisited

Posted: 17 Feb 2017 06:37 AM PST
By Karla L. Palmer & Andrew J. Hull –

A few months ago, we blogged on the DEA Acting Administrator’s use of official notice in final orders. Specifically, we questioned the Acting Administrator’s recent practice of relying on facts outside of the record (typically publically available state pharmacy board records) without taking official notice and providing the respondent an opportunity to challenge those findings.  We asserted that this practice violates the Administrative Procedure Act’s (APA) minimal notice requirements and deprives aggrieved parties of due process.  We note that in a final order published last Friday, Paul E. Pilgram, M.D., 82 Fed. Reg. 11,058 (Feb. 17, 2017), the Acting Administrator opted to follow the proper APA procedures for taking official notice of state pharmacy board records.

The case involved a loss of state authority (see also our recent post here) in which the Acting Administrator relied on the results of a search of Utah’s licensing agency’s website confirming that the registrant’s state license remained revoked before revoking the registrant’s DEA registration. The Acting Administrator properly noted that he was taking official notice of the state board record, and provided the registrant with fifteen days to challenge his finding:

In accordance with the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding-even in the final decision.” U.S. Dept. of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).  In accordance with the APA and DEA’s regulations, Respondent is “entitled on timely request to an opportunity to show to the contrary.”  5 U.S.C. § 556(e); see also 21 CFR 1316.59(e).  To allow Respondent the opportunity to refute the facts of which I take official notice, Respondent may file a motion for reconsideration within 15 calendar days of the date of service of this Order which shall commence on the date this Order is mailed.
Pilgram, 82 Fed. Reg. at 11,059 n.4.

While this practice still does not clear up other concerns with DEA administrative practice we discussed in our previous blog post (such as DEA employees engaging in both investigative functions for the agency and subsequent participation in agency review of those investigatory functions, see 5 U.S.C. § 554(d)), we are encouraged that DEA indeed is recognizing in certain instances due process rights of the parties that appear before the agency in administrative proceedings.


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