Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/02/index.html
Timestamp: 2017-04-26 10:05:11
Document Index: 792669092

Matched Legal Cases: ['§ 802', '§ 262', '§ 262', '§ 262', '§ 262', '§ 262']

FDA Law Blog: February 2017
Ten Years On, FDA Still Has Not Eased The Medical Device Reporting Regulatory Burden As Directed by Congress By Jeffrey K. Shapiro –
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, will present with a panel of experts and provide an overview of the Hatch-Waxman Amendments and the Biologic Price Competition and Innovation Act (“BPCIA”). Mr. Karst will also head one of leading workshops on the program: “Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute,” Mr. Karst will deconstruct, in a step-by-step manner, a complex exclusivity dispute, analyzing FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity. Relevant court decisions will also be analyzed and their practical and future effects discussed. After the exclusivity case analysis is completed, attendees will have the opportunity to construct their own exclusivity dispute by choosing from various base facts. Once the case is constructed, Mr. Karst will lead attendees through the exclusivity analysis. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: P10-999-FDAB17. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference.
Posted at 04:28 PM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink
Posted at 06:57 PM in Foods, Foods and Dietary Supplements | Permalink
By Larry K. Houck & Riëtte van Laack – Last month we reported that the Hemp Industries Association (“HIA”) petitioned the U.S. Court of Appeals for the Ninth Circuit to block the Drug Enforcement Administration’s (“DEA’s”) implementation of its recent final rule on marijuana extracts. On February 6, 2017, HIA filed another action with the Ninth Circuit; this one seeking to direct DEA to show cause why it should not be held in contempt, for failure to comply with the Court’s 2004 order that permanently enjoined DEA from regulating hemp fiber, stalk, sterilized seed and oil as controlled substances. The federal Controlled Substances Act (“CSA”) specifically excludes these parts of the plant from its definition of “marihuana.” 21 U.S.C. § 802(16).
Posted at 05:37 PM in Controlled Substances, Drug Enforcement Administration | Permalink
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:
Posted at 05:30 PM in Controlled Substances, Drug Enforcement Administration | Permalink
On Wednesday February 15, Genentech brought an action for declaratory judgment against Amgen for failure to comply with the patent dance provisions of the BPCIA. In November 2016, Amgen submitted an aBLA to FDA relying on Genentech’s cancer drug Avastin as the reference product. The aBLA was accepted for review on January 4, 2017, triggering the patent dance (should Amgen choose to participate). In an interesting footnote, Genentech distinguished this case from the aforementioned Amgen Inc. v. Sandoz because Amgen did, indeed, choose to participate rather than attempt to opt out of the BPCIA patent dance altogether. According to Genentech, Amgen started the patent dance and provided Genentech a copy of its aBLA within 20 days, but refused to provide any information on the manufacturing process as required under 42 U.S.C. § 262(l)(2)(A). Additionally, Amgen allegedly insisted that Genentech’s patent counsel could evaluate proposed infringement and withheld consent to expert participation in violation of 42 U.S.C. § 262(l)(1)(C). With only 60 days to deliver a list of patents that “could reasonably be asserted” against Amgen’s proposed aBLA, Genentech stresses in its complaint that it needs the “other information” under § 262(l)(2)(A) to preserve its applicable patent rights. For this reason, Genentech requests a declaratory judgment as well as an order declaring that Amgen has failed to comply with its obligations under 42 U.S.C. § 262(l)(1)(C) and § 262(l)(2)(A), directing Amgen to comply, resetting the BPCIA deadlines for resolving patent disputes, and prohibiting Amgen from selling its proposed biosimilar until the statutory process is complete.
Posted at 02:21 PM in Biosimilars, Prescription Drugs and Biologics | Permalink