On October 26, 2017, Par Sterile Products, LLC and Endo Par Innovation Company filed a Complaint in the United States District Court for the District of Columbia against the Food and Drug Administration. At the heart of the Complaint is FDA’s Interim Policy addressing compounding …
Earlier this week, the U.S. District Court for the District of Columbia issued a Memorandum Opinion granting summary judgment to FDA in a lawsuit Lannett Company Inc. and Lannett Holdings, Inc. (collectively “Lannett”) filed in June 2016 challenging FDA’s rescission of Lannett’s ANDA 202750 for the …
The Food and Drug Law Institute’s (“FDLI”) Drug Quality and Security Act (“DQSA”) conference is just a few weeks away, and spaces are going fast! The conference will be held on November 15, 2017, in Washington, D.C. Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer …
On October 9, 2017, California Governor Jerry Brown signed into law a bill (SB 17), which imposes new notification and reporting requirements on pharmaceutical companies, health care service plans, and health insurers. Among the many reporting obligations under SB 17, we describe below only those …
Today (October 12, 2017) FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee unanimously recommended approval of Spark Therapeutics, Inc.’s Biologics License Application (BLA 125610) for Voretigene Neparvovec (also called LUXTURNA), a gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65 …
Pushing forward with his commitment to accessibility, Commissioner Gottlieb recently announced further efforts to encourage generic approval. In another FDA Voice Blog Post, Dr. Gottlieb reiterated the agency’s renewed focus on drug pricing and competition and announced new measures to aid in the development of …
Late last month, Judge Wolf, in the federal district court for the district of Massachusetts, dismissed a putative class action against a number of defendants based on impossibility preemption. The plaintiffs’ basic allegations were that the defendants, all of which manufactured or distributed prescription eye drops, …
We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance …
On September 26, 2017, FDA combined and finalized two Draft Guidance documents first issued in 2011 that set forth the Agency’s approach to classifying products as “drugs” or “devices” under the FDC Act § 201. In doing so, FDA trimmed significant portions of both Draft …
Puerto Rico has been a hub of pharmaceutical manufacturing for some time, but in the aftermath of hurricane Maria (and Irma), that has changed – at least for now. Without power in most of the island, but more importantly, without employees who can get to …
Hyman, Phelps & McNamara, P.C.’s Mark I. Schwartz will be presenting on the Regulation of Biological Manufacturing at the Food and Drug Law Institute's (“FDLI’s”) Introduction to U.S. Biologics and Biosimilars Law and Regulation course, which is scheduled to take place from October 4-5, 2017 in Washington, …
Earlier this week, FDA published another in its series of guidance documents devoted to implementing the Biologics Price Competition and Innovation Act (“BPCIA”). The objective of the new guidance, entitled Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry, is to assist sponsors in demonstrating …
If you read our blog, you already know that the 21st Century Cures Act included a provision that created the Regenerative Advanced Therapy designation program, or “RAT” (see our previous coverage of the Act here). You will also already know that the Center for Biologics …
It is the False Claims Act (FCA) case that wouldn’t die. The complaint in United States ex rel. King v. Solvay Pharmaceuticals, Inc. was originally filed in 2006 in the U.S. District Court for the Southern District of Texas. Through a series of partial summary …
After this year’s unanimous Supreme Court decision in Amgen v. Sandoz was remanded to the Federal Circuit (see our previous post here), that Court is now in the midst of addressing Biologics Price Competition and Innovation Act (“BPCIA”) state law preemption. In August, the parties …
