By Jay W. Cormier & Anne K. Walsh – It was a big day in January 2009 when FDA finally issued guidance for manufacturers governing the distribution of medical journal articles and reference publications. While some guidance was better than no guidance, FDA received several comments …
By Jeffrey N. Wasserstein & Delia A. Stubbs – For years, those of us who followed FDA’s attempt to provide guidance related to social media felt like Vladimir and Estragon from Samuel Beckett’s Waiting for Godot. FDA initially promised guidance by the end of 2010. But, …
By Dara Katcher Levy – A new Warning Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) suggests that FDA may want a new fight when it comes to the issue of that pesky First Amendment and the interplay with FDA-regulated products. In a November 8, …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
By Jamie K. Wolszon & Alan M. Kirshenbaum ¬− On June 3, 2013, the U.S. District Court for the Southern District of New York ruled that a drug company co-pay subsidy program did not violate the Racketeer Influenced and Corrupt Organizations Act (RICO) under theories of …
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 Jeff Wasserstein & Dara Katcher Levy – FDA’s Office of Prescription Drug Promotion (“OPDP”) recently issued an untitled letter to Cornerstone Therapeutics, Inc. relating to Cornerstone’s drug Curosurf (see here and here). The allegations in the letter are unremarkable and contain the usual claims …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will moderate a panel on “Trends and Priorities in Enforcement” at this year’s Food and Drug Law Institute’s (“FDLI”) Advertising and Promotion Conference. The conference will be held in Washington, DC on October …
By Jennifer M. Thomas & Jeffrey N. Wasserstein – Many pharmaceutical companies sponsor prescription drug coupons and other cost-savings programs to help reduce the burden of co-payments and co-insurance. Lawsuits filed against nine pharmaceutical companies in four federal district courts on March 7 by various union health …
By Alex J. Varond - On March 5, 2012, the Department of Veterans Affairs ("VA") issued a final regulation on promotion of drug and drug-related products (i.e., supplies related to the use of a drug, such as insulin needles and inhalers) by pharmaceutical company representatives at …
By Jamie K. Wolszon & Alan M. Kirschenbaum – FDA has issued two important documents bearing on communications regarding off-label uses and (in one of the documents) not-yet-approved products. The first, which was posted on FDA’s web site earlier this week, was a draft guidance on …
By Dara Katcher Levy – Last week, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) released an Untitled Letter issued to Novartis on May 31st, which alleges the company made unsubstantiated superiority claims in a detail aid for its ADHD drug, Focalin XR. Unlike most …
By Jeffrey N. Wasserstein – As aficionados of all things social media (see our prior postings here, here, here, and here) (other than kitten videos, enough with those already!) we couldn’t help but notice a recent Untitled Letter to Warner Chilcott, LLC, relating to a YouTube video. A …
By Dara Katcher Levy – FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) has announced that it will be holding a series of Enforcement Webinars that will provide an opportunity for attendees to ask DDMAC questions about the Warning and Untitled Letters it issues each …
Hyman, Phelps & McNamara's Jeffrey N. Wasserstein (co-founder of the FDA Law Blog) will be moderating a panel on social media and therapeutic products at the FDLI Annual Meeting, April 5-6, 2011, at the Ronald Reagan International Trade Center, in Washington, DC. The panel will …
