In July, as reported here, the Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against Gilead Sciences, Inc. Not surprisingly, Gilead timely filed a petition for rehearing or rehearing en banc with the Ninth Circuit, and several groups submitted …
On September 1, 2017, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), jointly filed a civil action seeking declaratory and injunctive relief against the Nevada Governor and Director of the Nevada Department of Health and Human Services …
FDA seems to be getting bolder in penalizing industry when it prevents an FDA investigator from taking photographs during a routine FDA inspection. On August 2, 2017, FDA issued a Warning Letter to Homeolab USA Inc. (part of the parent company, Homeocan Inc. located in Montreal, …
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 …
After a lengthy struggle that began with a major Salmonella outbreak in 2010, Jack and Peter DeCosters’ criminal case came to an end on May 22, 2017 when the U.S. Supreme Court denied their petition for writ of certiorari. We have followed this case with …
Antibiotic-resistant bacteria are claimed to be one of the biggest threats to global health, sickening an estimated 2 million people in the United States each year. There is evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). …
On Monday, March 27, FDA and the Society of Toxicology (SOT) will present a colloquium (chaired by Bernadene A. Magnuson, PhD, Health Science Consultants, Inc., and Sabine Francke, DVM, PhD, CFSAN FDA) on Considerations for the Determination of Adversity in Food Chemical Safety Evaluations, the …
Oh Canada! Congress has decided that it’s once again time to start looking to our neighbors to the north for some help increasing accessibility and decreasing cost of prescription drugs. With two new bills introduced in the last month, one in each chamber of Congress, …
On Friday, Amgen submitted its Opening and Response Brief at the Supreme Court in the matter of Sandoz v. Amgen, Nos. 15-1039, 15-1195. The brief addressed two major questions with respect to the BPCIA: when an applicant can provide 180-day notice of biosimilar marketing and …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice. The ideal candidate for one position is an attorney with substantive expertise in medical device regulation. The other attorney is …
By Andrew J. Hull & Mark I. Schwartz On Tuesday, the U.S. Court of Appeals for the Federal Circuit affirmed a preliminary injunction against Apotex Inc. and Apotex Corp. (collectively, “Apotex”) related to Apotex’s biosimilar version of Amgen Inc. and Amgen Manufacturing Limited’s (collectively, “Amgen’s”) NEULASTA …
By Allyson B. Mullen, Jeff N. Gibbs, McKenzie E. Cato* – Technological advances have resulted in Next Generation Sequencing (NGS) being used more and more frequently by diagnostic laboratories. NGS in vitro diagnostics (IVDs) present a new set of regulatory and technical challenges for FDA and …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice. The ideal candidate for one position is an attorney with substantive expertise in medical device regulation. The other attorney is …
By Karla L. Palmer – The Government Accountability Office (GAO) issued three reports during 2015 making eleven recommendations to the Drug Enforcement Administration (DEA) to more effectively perform their functions under the Controlled Substances Act (CSA) and DEA’s implementing regulations (see previous posts here and here). GAO now reports that, …
