On Thursday, United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring HP&M Director Frank Sasinowski for his contributions to UTC’s development …
By Kurt R. Karst – Company submissions to the Securities and Exchange Commission (“SEC”) can be a valuable source of information. Consider, for example, a recent quarterly report from Celgene Corporation, which states with respect to Risk Evaluation and Mitigation Strategies (“REMS”) that: In the fourth quarter …
By Peter M. Jaensch & John R. Fleder – A company has “current Good Manufacturing Practice” (“cGMP”) issues. FDA learns about the issues and engages in dialogue with the company regarding the purported violations. No big deal and no news story! Add in a terminated employee who files …
By Kurt R. Karst – Some Senate Democrats have joined their Republican colleagues in voicing opposition to the inclusion of the “Preserve Access to Affordable Generics Act” (S. 369) in the Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677). As we previously …
By Dara Katcher Levy – How many lawsuits will it take before FDA starts exercising better judgment on imports? On October 25, 2010, Amphastar Pharmaceuticals Inc. (“Amphastar”) filed suit against FDA seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of …
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 …
