jueves, 27 de octubre de 2016

FDA Law Blog: DEA Administrative Hearings: “Open to the Public” Requires Notice to the Public

FDA Law Blog: DEA Administrative Hearings: “Open to the Public” Requires Notice to the Public



Posted: 26 Oct 2016 08:03 PM PDT
By John A. Gilbert, Jr. & Andrew J. Hull –

The Controlled Substances Act (“CSA”) and regulations promulgated by the Drug Enforcement Administration (“DEA”) provide for a right to an administrative hearing in matters where DEA seeks denial or revocation of a DEA registration to handle controlled substances. Such hearings are required to be open to the public. However, there is no routine publication identifying when such hearings will take place. The public, especially other DEA registrants, would benefit from such notice and the opportunity to observe the DEA administrative process.

Many of our readers are likely familiar with DEA’s hearing procedures (see here for an in-depth analysis). When the agency proposes to deny an application for registration or revoke or suspend an existing registration, the agency will issue the party an order to show cause (“OSC”), which provides the registrant a right to request a hearing on this action. In these cases, DEA regulations provide for the matter to be placed on the docket of DEA’s Office of Administrative Law Judges (“OALJ”) and for a hearing to be scheduled before an administrative law judge (“ALJ”).

These hearings are open to the public. See 5 U.S.C. § 556; Am. Bar Ass’n, A Blackletter Statement of Federal Administrative Law, 54 Admin. L. Rev. 1, 20 (2002). However, in most matters, the first time there is any mention in the public record of a hearing is after the hearing is concluded and, in fact, after the ALJ has issued a recommended opinion and the agency has published its final decision, known as a final order, in the Federal Register. According to a 2014 report by DOJ’s Office of the Inspector General (“OIG Report”), the average time it took to adjudicate a matter in 2012 was 371 days (down from an average of 616 days in 2008). OIG Report at 15. As such, a matter may be pending before the agency for a year (or longer) without any notice to the public until it is finally resolved.

Neither the CSA nor DEA’s regulations require that DEA notify the public of an upcoming hearing regarding the denial, revocation, or suspension of most registrations, though an exception applies to bulk manufacturers of a basic class of controlled substances listed in Schedule I and Schedule II. See 21 C.F.R. § 1301.35(b) (requiring notice of hearing in the Federal Register). Instead, DEA’s regulations allow for the notice of hearing to be provided in the OSC served on the individual party in lieu of publication in the Federal Register. See id. § 1301.45 (“The hearing will commence at the place and time designated in the order to show cause or notice of hearing published in the Federal Register . . . .”).

DEA administrative hearings are supposed to be open to the public. The problem is that the public is unlikely to even know that action is being taken against a particular registrant or that a hearing is taking place until after DEA publishes a final order. While DEA should make the existence of these cases and hearings known to the public, particularly because these hearings are public, DEA does not maintain any sort of public hearing docket. The only recourse for members of the public who are interested in following DEA’s ongoing hearings is 1) to contact DEA’s Office of Congressional & Public Affairs and blindly ask if there are any ongoing cases and whether there are any scheduled hearings, or 2) attempt to obtain this information through a FOIA request. We here at FDA Law Blog have tried both methods without much success.

Other federal agencies provide much greater access to information about hearings, along with the ability to view documents filed by the parties in the public docket. For example, the Environmental Protection Agency, the Federal Trade Commission, and the National Labor Relations Board all maintain current dockets that are available to the public on their websites (see herehere, and here).

We recognize that some DEA administrative hearings by their nature should not be totally “open” to the public. For example, some portions of cases may involve trade secrets or other confidential commercial information. However, we can also see some benefits to the public if DEA was to maintain a public docket or otherwise alert the public of ongoing administrative hearings.

First, a public hearing docket would generally create better public access to public information, one of the stated goals of the current administration. See Memorandum from President Barack Obama to Heads of Executive Departments and Agencies on Transparency and Open Government, 74 Fed. Reg. 4685 (Jan. 26, 2009). Second, access to such information could help other registrants fulfill their obligations under the CSA to help protect the public from the risk of diversion. For example, a pharmacy that learns that DEA has issued an OSC proposing to revoke the registration of one of its physician customers may choose to perform additional due diligence, including attending the hearing and/or no longer filling prescriptions for that physician as part of its corresponding responsibility. See 21 C.F.R. § 1316.04(a). Third, public knowledge of ongoing cases would allow interested parties to intervene or file amicus briefs at the discretion of the agency.

DEA has been criticized in recent years by the courts and industry as to its lack of transparency in operations. Providing access to DEA’s ongoing administrative hearing docket would be a great service to industry and the public as a whole, and would go a long way in ensuring greater openness. The most accessible and transparent method would be to maintain an online docket that, at the bare minimum, lists cases where a party has requested a hearing and details the hearing place and date.

DEA has indicated that it intends to significantly revise its hearing regulations. See OIG Report at 41, 46. Creating a hearing docket accessible to the public at the same time it introduces these new hearing regulations would be a significant and helpful step forward by DEA in promoting openness and transparency on matters that should already be open to the public.