On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:
FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)
The U.S. Food and Drug Administration (FDA) recently published a report titled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),” which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA’s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.
FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA
The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort “to speed access to safe and effective generic drugs to the public and reduce costs to industry.” In July 2014, the U.S. Food and Drug Administration issued two draft Guidances for Industry: one relating to Prior Approval Supplements Under GDUFA and one relating to Amendments and Easily Correctable Deficiencies Under GDUFA.
Click here to read the full Alert written by Duane Morris partner Rick Ball and associate Carolyn Alenci.
Duane Morris Partner Frederick Ball to Moderate at the FDLI’s Conference, Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs
Duane Morris partner Frederick R. Ball will be serving as a moderator on a session titled “The Present Part 2: Generic Industry Challenges and Current Issues” at the Food and Drug Law Institute’s conference. The conference, Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs, will take place on September 18, 2014 in Washington, D.C. Mr. Ball’s session will begin at 1:45 p.m.
FDA Gives Guidance on Compounding for Human Use
In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use. These FDA guidance documents and proposed rule are the latest FDA action to implement its new authority under the CQA to regulate the compounding of drugs for human use. FDA’s current thinking, its proposed regulation and Final Guidance are key guideposts for entities compounding for human use under either Section 503A, Section 503B, or both.
Click here to read the full Alert.
FDA Issues Draft Guidance for Identification and Notification of Suspect Products
As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States.” Recently, the U.S. Food and Drug Administration (FDA) has issued a draft Guidance for Industry for implementing the DSCSA with respect to identification of suspect products and notification thereof.
Starting January 1, 2015, trading partners and manufacturers are required to “notify FDA and immediate trading partners (that they have reason to believe may have received [or possess] the illegitimate product) not later than 24 hours after making the determination.”
Click here to read the full Alert, written by Duane Morris partner Rick Ball and associate Carolyn Alenci.
FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products (“FDA stability guidance”) that was published in the Federal Register on September 25, 2012. It also incorporates comments received on the same draft, which were previously published in the Federal Register on August 27, 2013.
Click here to read this Alert, written by Duane Morris Partner Rick Ball and associate Emily Winfield.
Successful Use of Inter Partes Review to Cancel Claims Asserted in Parallel Litigation
By Vicki G. Norton, Siegfried J.W. Ruppert, and Michael Swit
In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next generation DNA sequencing technology, after Illumina, Inc. countered Columbia University’s patent infringement suit by successfully petitioning for IPR of claims in three of five of Columbia’s patents-in-suit.
The decisions illustrate the utility of the new IPR process before the PTAB, implemented under the America Invents Act (AIA), as a parallel venue in which patent litigation defendants can challenge the patentability of claims asserted against them in litigation, more expeditiously and less costly than in court proceedings.
Court Offers Insights On When the 271(e)(1) Safe Harbor Applies to the Use of Patented Technology in Early – and Late — Drug Development
By Vicki G. Norton and Michael A. Swit
FDA-regulated firms — drug, device, biologic or otherwise — on both sides of the patent aisle concerned with the bounds of the “Safe Harbor” exception to patent infringement under 35 U.S.C. § 271(e)(1) can learn several key lessons from the recent decision in Isis Pharmaceuticals, Inc. v Santaris Pharma A/S Corp. (hereafter: “Isis”), particularly how to properly prove the safe harbor defense once the litigation unfolds and also when the harbor provides shelter from post-approval patent storms.
Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products
On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. Section 54.1-3408.04 of the Code of Virginia permits pharmacists to dispense a biosimilar in place of a prescribed biological product only if that biosimilar meets the higher safety standards for “interchangeability” under the federal Biologics Price Competition and Innovation Act of 2009. Section 54.1-3408.04 raises additional hurdles for biosimilar and interchangeable biologic drug manufacturers by imposing recordkeeping and prescriber and patient notification requirements on a pharmacist dispensing an interchangeable biosimilar in the place of a prescribed biological product. In contrast, pharmacists are not subject to those burdens when substituting a therapeutically equivalent small-molecule generic drug for a prescribed branded drug. The provisions of the Act are discussed in more detail in a March 28, 2013 Duane Morris client alert (click here).