domingo, 20 de agosto de 2017

CDRH New Update

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CDRHNew

Date: August 14, 2017

The following new item was added to the CDRH web pages on August 11, 2017. Previous items can be found on the CDRHNew Page.

FDA Law Blog: ACI’s 5th Annual Paragraph IV Disputes Master Symposium

FDA Law Blog: ACI’s 5th Annual Paragraph IV Disputes Master Symposium



Posted: 01 Aug 2017 12:36 PM PDT
The American Conference Institute’s (“ACI’s”) 5th annual “Paragraph IV Disputes Master Symposium” is coming up! The conference will take place from October 2-3, 2017 at the InterContinental Chicago Magnificent Mile in Chicago, Illinois.

ACI has put together an excellent program for conference attendees that include presentations from esteemed Judges and key representatives from the FDA and the PTO. In addition, attendees will get to hear from a virtual “who’s who” of Hatch-Waxman litigators and industry decision makers.  Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, will be speaking at a session titled “Brand and Generic Perspectives on the FDA Final MMA Rule: Assessing Its Impact on Hatch-Waxman Practice.”

FDA Law Blog is a conference media partner. As such, we can offer our readers a 10% discount off the current price tier.  The discount code is: P10-999-FDAB18.  You can access the conference brochure and sign up for the event here.

We look forward to seeing you at the conference.


FDA Law Blog: Discovery in the BPCIA Era: Federal Circuit Rules in Amgen v. Hospira EPOGEN Biosimilar Dispute

FDA Law Blog: Discovery in the BPCIA Era: Federal Circuit Rules in Amgen v. Hospira EPOGEN Biosimilar Dispute



Posted: 13 Aug 2017 07:13 PM PDT
By Sara W. Koblitz –

As we mentioned back in July, courts continue to address a wide variety of procedural questions arising from the Biologics Price Competition and Innovation Act (“BPCIA”). The most recent is a decision from the Federal Circuit in an interlocutory appeal pending since July 2016 in the revised Amgen v. Hospira matter, Case 1:15-cv-00839 (D. Del.), No. 2016-2179 (Fed. Cir. 2017).  Like many of the recent BPCIA actions of late, this case raises questions about how a reference product sponsor can adequately assert its patent rights when the biosimilar sponsor doesn’t provide all of its manufacturing information.

Here, the Federal Circuit essentially told Amgen that it won’t mandate discovery to support a fishing expedition.  Alleging various failures to comply with the BPCIA, Amgen filed its initial patent infringement complaint against Hospira with respect to a biosimilar version of Epogen in the District Court of Delaware. In the course of this litigation, Amgen appealed to the Federal Circuit the District Court’s denial of its Motion to Compel Discovery of Hospira’s biosimilar manufacturing process and related cell-culture information.  In the alternative, Amgen requested a Writ of Mandamus order to compel discovery.  The Federal Circuit denied both of these requests as meritless.

Disposing of the Motion to Compel Discovery quickly, the Federal Circuit explained that it lacked jurisdiction over the Motion to Compel under the collateral order doctrine, as discovery rulings generally do not qualify for exception to the final judgement rule (requiring parties to wait until final judgment to appeal rulings). Amgen argued that waiting until final judgment renders the decision “effectively unreviewable,” but the Federal Circuit could not identify a clear-cut statutory purpose undermined by denying immediate appeal.

In the alternative, Amgen argued for mandamus under the All Writs Act ordering the District Court to compel discovery. The Federal Circuit explained that mandamus is a drastic remedy reserved for extraordinary cases with no other means to attain the requested relief; a party seeking this remedy must demonstrate “clear and indisputable” right to such relief.  Here, the Federal Circuit could not identify a “clear and indisputable” right to the cell-culture information.  The Court explained that the BCPIA, as interpreted by the Supreme Court in Sandoz v. Amgen, leaves two relevant avenues for Amgen to secure process information from Hospira: sue for infringement of the patents included on the patent list exchanged with Hospira or sue for infringement of a patent that could be identified on such a list of patents.  Because Amgen did not list any of or bring suit on any of its cell-culture patents, the cell-culture process is not relevant to any claim of infringement asserted by Amgen (or any of Hospira’s defenses or counterclaims).  Amgen even conceded as much.

The Federal Circuit emphasized that “[n]othing in Sandoz suggests that the BPCIA somehow supplants the preexisting rules of civil procedure.”  While a sponsor may access information through discovery and a sponsor may list or sue on a patent for which an applicant has not provided information – all without risking Rule 11 sanctions (targeting arguments that have no evidentiary support) – the usual rules governing discovery still apply in the BPCIA context.  While an outline of BPCIA-avenues for obtaining withheld information certainly helps provide clarity, the denial of this interlocutory appeal isn’t surprising.  Nothing in Sandoz or any other BPCIA decision indicates a shit in civil procedures rules, but it is always helpful to have that in writing.

For now, Amgen v. Hospira continues on . . . without cell-culture information. 

FDA Law Blog: FDA Action Against Outsourcing Facility, the Sequel

FDA Law Blog: FDA Action Against Outsourcing Facility, the Sequel



Posted: 14 Aug 2017 07:16 PM PDT
By Douglas B. Farquhar –

Just last month, we blogged about what we believe to be the first Consent Decree signed by the government and an Outsourcing Facility, shutting down operations under judicial order until certain rigorous conditions are met.  Now, comes the second.

Isomeric Pharmacy Solutions, LLC and three affiliated individuals (all Defendants in the matter) signed a Consent Decree that was entered in federal court in Utah (U.S. District Court for the Central Division of the District of Utah) on August 3.  The Outsourcing Facility was also the subject of a Warning Letter in December 2016 and a recall about four months ago.

The Complaint filed in the case alleges that the named individual Defendants were owners or the Chief Operating Officer for the Outsourcing Facility, and that the Outsourcing Facility distributed drugs that were supposed to be sterile but that had “visible black particles” in a preservative-free injectable drug.  The Complaint also alleged that Isomeric found “spore-forming bacteria” in media fills (which are designed to demonstrate that there are no breaches of sterility in the manufacturing process), and contamination of aseptic processing areas with bacteria and fungus.  While the Complaint alleges that Isomeric detected flaws in products relating to, for example, particle size, the Complaint does not allege that any microbial contamination was found in products.  The Complaint also alleges that Isomeric distributed unapproved new drugs.

Under the terms of the Consent Decree, the Defendants are prohibited from distributing drugs manufactured at any of their facilities until and unless they take hire a qualified consultant who determines they are operating in compliance with current FDA’s Good Manufacturing Practice requirements, and FDA certifies, in writing, that FDA agrees.

Outsourcing Facilities are relatively new, quasi-drug manufacturing entities established by legislation in November of 2013 (see our previous post here).  They are permitted to compound and distribute certain drugs under certain conditions, without FDA approvals, adequate directions for use , compliance with new serialization and other drug tracking requirements, and without patient-specific prescriptions from health care providers (so-called “office use” compounding).


NGC Update Service: August 14, 2017 | U.S. Preventive Services Task Force

NGC Update Service: August 14, 2017

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U.S. Preventive Services Task Force

NGC Update Service: August 14, 2017 | Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society

NGC Update Service: August 14, 2017

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Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society

NGC Update Service: August 14, 2017 | American College of Chest Physicians

NGC Update Service: August 14, 2017

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Guideline Summaries

American College of Chest Physicians