By John R. Fleder – For many years, FDA has taken the public position that nongovernmental entities cannot enforce the Federal Food, Drug, and Cosmetic Act. That position has not deterred lawsuits against businesses under statutes other than the FDCA, arguing that the defendants’ conduct violated …
By JP Ellison – Last week, John Roth, the Director of FDA’s Office of Criminal Investigations posted on FDA’s blog, FDA Voice. His post concerned a criminal case that had interested us about a Montana resident who had pled guilty and been sentenced on a …
By Kurt R. Karst – In a unanimous decision handed down on July 23rd by a 3-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit in Cook v. FDA (Case No. 12-5176), the Court largely affirmed a March 2012 decision …
By Doug Farquhar – For decades (although not quite since the invention of film), the debate has raged among lawyers who advise clients about FDA inspections: can regulated industry insist that FDA investigators conducting inspections without a warrant put away their cameras, when the investigators try …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
By Paul M. Hyman – As we have discussed previously, the Park doctrine allows the government to seek a misdemeanor conviction against a company official for alleged violations of the Federal Food, Drug, and Cosmetic Act ("FDCA") without having to prove that the official participated in …
Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention. FDA recently issued a warning letter to a company that …
By Ricardo Carvajal – Our colleagues at the Drug and Device Law Blog recently blogged on the decision in Wilson v. Frito-Lay North America, Inc., a false advertising case out of the Northern District of California in which the court held that statements on a food …
By Karla L. Palmer & Jeffrey N. Gibbs – On April 10, 2013, the Department of Health and Human Services’ Office of Inspector General (“OIG”) released a Memorandum Report titled, “High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them.” The OIG Report provides …
By Karla L. Palmer & Jeffrey N. Gibbs – On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections. The Agency states that it had taken critical look at its …
By Kurt R. Karst – Briefing is underway in K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA …
By Carmelina G. Allis – On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter” in the form of an email (an “untitled email”) to on-line distributors of decorative contact …
By Anne K. Walsh – On March 4, 2013, less than three months after oral argument, the Ninth Circuit issued its ruling in United States v. Harkonen, a closely watched case implicating First Amendment issues in the off-label promotion context. As we previously reported (here …
In a new Contemporary Legal Note published by the Washington Legal Foundation (“WLF”), titled “Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations,” Hyman, Phelps & McNamara P.C. Director Douglas B. Farquhar explores issues surrounding privileged material and so-called “taint teams” when government investigators …
On January 31, 2013, Hyman, Phelps & McNamara, P.C. presented a webinar addressing the real-world implications from the Second Circuit decision in United States v. Caronia. Panelists addressed the potential impacts to the pharmaceutical, devices, dietary supplements, and tobacco industries. HP&M was quite pleased that …
