By Kurt R. Karst – For years we’ve heard rumors of a relatively current list, compiled by FDA, of proceedings pending under the Drug Efficacy Study Implementation (“DESI”) program. At one time, in the early 1980s, the list was included as an addendum to the Orange …
By Ricardo Carvajal - Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril. For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and …
By Anne K. Walsh – On November 2, 2011, DOJ’s Assistant Attorney General Tony West gave a keynote address at the Twelfth Annual Pharmaceutical Regulatory and Compliance Congress in Washington, DC. During that speech, he touted DOJ’s “successes” against health care fraud achieved during the last …
The Food and Drug Law Institute’s (“FLDI”) annual Enforcement, Litigation and Compliance Conference is being held in Washington, DC on December 6-7, 2011. Hyman, Phelps & McNamara, P.C. Director John R. Fleder is speaking at the conference. As a result, we were able to secure …
By Kurt R. Karst – In a decision handed down late last week by the U.S. Court of Appeals for the Tenth Circuit, a three-judge panel affirmed a November 2010 decision from the U.S. District Court for the District of Wyoming granting FDA’s Motion to Dismiss …
By Wiliam T. Koustas & John R. Fleder – We recently reported on FDA’s attempt to assert its authority over intrastate commerce through a novel interpretation of “interstate commerce” under the Federal Food, Drug, and Cosmetic Act (“FDCA”). Regenerative Sciences, Inc. (“Regenerative”) is challenging FDA’s claim …
By Ricardo Carvajal – FDA announced its first seizure of a food that was administratively detained pursuant to FDA’s expanded authority under the Food Safety Modernization Act ("FSMA"). FSMA amended the FDC Act to make it easier for FDA to exercise the administrative detention authority that …
By Wes Siegner – We recently reported that on September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs …
By John R. Fleder – It is no secret that the government has devoted considerable resources in recent years seeking to combat what it has contended is wide-spread illegal off-label marketing and promotion of devices and drugs. Many people believe that the government has created this …
By William T. Koustas – We have previously reported (here and here) continuing legal saga of the former Purdue Frederick Co. (“Purdue”) executives who are seeking to reverse a Department of Health and Human Services (“HHS”) decision to exclude their participation in federal healthcare programs. In …
By Kurt R. Karst – On September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”) (FDA Docket No. 2003D-0478), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved …
By Wes Siegner, John R. Fleder & Ricardo Carvajal – In U.S. v. Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues. Although nominally a veterinary drug case, …
By Carmelina G. Allis – If you thought you’ve had enough trying to figure out whether FDA regulates your mobile app, watch out for the FTC. The FTC has brought its first case targeting health claims related to mobile medical apps. The mobile apps, sold in Apple’s …
By William T. Koustas & John R. Fleder – Google, Inc. (“Google”) and the Department of Justice (“DOJ”) (acting in concert with FDA’s Office of Criminal Investigations) have settled the government’s criminal investigation into Google’s AdWords program, which displayed advertisements on websites for online Canadian pharmacies. …
By Kurt R. Karst – The court battle over the “new drug” status of Cody Laboratories, Inc.’s and Lannett Co., Inc.’s (collectively “Cody/Lannett’s”) Morphine Sulfate Oral Solution 20mg/mL drug product has taken a new turn. FDA’s Motion to Dismiss the case on mootness grounds has been …
