By Riëtte van Laack – Direct Marketing Concepts, Inc. (“DMC”) and other companies and individuals marketed Coral Calcium and Supreme Greens by producing and distributing infomercials claiming that these products were an effective cure against many diseases including heart disease, cancer, lupus, etc. The district court …
By Kurt R. Karst – FDA’s recent decision to grant an April 27, 2010 citizen petition submitted on behalf of Genzyme Corporation (“Genzyme”) concerning the Agency’s ability to approve Cobrek Pharmaceuticals, Inc.’s (“Cobrek’s”) pending ANDA for a generic version of HECTOROL (doxercalciferol) Injection sheds some light on …
By Ricardo Carvajal – The Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols (part of the Food and Nutrition Board at the Institute of Medicine of the National Academies) recently released a report on the first phase of its study of front-of-package ("FOP") nutrition …
By Jeffrey K. Shapiro – FDA’s Center for Devices and Radiological Health is conducting a usability study of the establishment registration and device listing database. The objective is to make the database easier to use. They are looking for feedback from those who regularly use the …
By Susan J. Matthees – Two consumers, a resident of Florida and a resident of New Jersey, have filed a putative class action against Basic Research LLC, Carter-Reed Company, LLC, Dennis Gay, Daniel Mowrey, and Mitchell Friedlander, alleging that Defendants made false and deceptive claims about …
By Kurt R. Karst – Earlier this month, President Obama signed into law S. 1674, the Improving Access to Clinical Trials Act (Pub. L. No. 111-255). The bill, introduced in the Senate by Senator Ron Wyden (D-OR) in September 2009, amends the Social Security Act (42 …
By Dara Katcher Levy & Diane B. McColl - Last week, FDA issued a draft guidance intended to assist sponsors and investigators with decisions as to whether human research studies can be conducted on products without an investigational new drug application ("IND"). The draft guidance explains …
By Alan M. Kirschenbaum – After conducting a regulatory exercise mandated by court order, the Department of Defense (“DoD”) on Friday issued a regulation that is virtually identical to a regulation issued in March 2009 to implement its TRICARE retail drug refund program. As we previously …
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, …
