By Douglas B. Farquhar – At a trade industry conference this week, a cadre of government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing FDA-regulated industries. They also discussed how the types of prosecutions may …
By Ricardo Carvajal – Last October, we noted that FDA and FTC issued a joint warning letter to an internet marketer of a dietary supplement promoted as helpful in preventing swine flu, seasonal flu, and colds. That letter was one of several that targeted similar products …
By Carmelina G. Allis – We previously reported on FDA’s August 2010 publication of a report recommending changes to the 510(k) program. We briefly discussed the proposed changes, and raised concerns with some of the agency’s recommendations because of their potential negative effect on the medical …
By Kurt R. Karst – 2011 is shaping up to be an interesting year in the Hatch-Waxman world, and all eyes seem to be focusing on what will happen with Ranbaxy’s purported (sole) 180-day exclusivity for a generic version of the mega-blockbuster drug LIPITOR (atorvastatin calcium) …
By Kurt R. Karst – Earlier this year we posted on the effects of the U.S. Court of Appeals for the Federal Circuit’s December 2009 “false marking” decision in Forest Group, Inc. v. Bon Tool Co. False marking is the act of placing an item in …
By John A. Gilbert & Peter M. Jaensch – On October 6, 2010, the Drug Enforcement Administration (“DEA”) announced a Statement of Policy concerning the procedure by which a registrant-prescriber may use an agent, including a nurse in a long term care facility (“LTCF”), to communicate controlled substances …
Hundreds of you have already signed up for Hyman, Phelps & McNamara, P.C.’s free webinar – The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine – scheduled for Friday, October 8, 12:00 p.m. – 1:30 p.m. For those last minute stragglers, …
By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) announced the issuance of proposed revisions to its “Green Guides,” last revised in 1998. The proposed revisions would update industry guidance on how to avoid making misleading environmental claims. In addition, Julie Brill, Commissioner of …
By Kurt R. Karst – Earlier this week, the Institute of Medicine (“IOM”) issued a 350-page report, titled “Rare Diseases and Orphan Products: Accelerating Research and Development,” which is intended to help refocus attention on accelerating rare diseases research and product development. The report is the …
By Kurt R. Karst – The U.S. Court of Appeals for the Federal Circuit answered “Yes” to this question in an October 6th decision in Teva v. Eisai (2009-1593) that could pave the way for generic versions of Eisai, Inc.s’ ARICEPT (donepezil HCl) Tablets sooner than …
By Kurt R. Karst – The voice of Michael Corleone – “Just when I thought I was out . . . they pull me back in” – played over and over again in our heads today when we learned that Apotex, Inc. filed a Petition for …
By Kurt R. Karst – In a short, but scathing opinion piece published in the October 5th Wall Street Journal (“WSJ”), the editors take on the Federal Trade Commission (“FTC”) and those Members of Congress who want to ban patent settlements between brand-name and generic drug …
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at the Center for Business Intelligence’s (“CBI’s”) 3rd Annual Life Sciences Congress on Paragraph IV Disputes, which is scheduled for October 18-19, 20109 at the Hilton Alexandria Old Town in Alexandria, Virginia. This popular …
By Ricardo Carvajal – No sooner did FDA hold its advisory committee meeting and public hearing on bioengineered AquAdvantage salmon than Congressional representatives made their displeasure known with the prospect of FDA approval. In addition to signing on to letters of protest to the Commissioner (here …
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. The webinar will feature attorneys with decades of experience in FDA’s application of …
