It feels like déjà vu. In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products; late in 2014, FDA committed to issuing new guidance by the end of 2014 to address …
After a relatively slow first 11 months of 2016, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a flurry of letters in the span of 9 days in December, more than doubling the enforcement letters issued up to that point in the year. And the …
Your friendly neighborhood bloggers were tempted to headline this post with a Buzzfeed worthy headline such as “When FDA pointed out THIS ONE THING, industry was SHOCKED!” or “FDA issues flood of letters – 25% of 2016 output in a single day. What happened next …
By Anne K. Walsh & Andrew J. Hull – FDA announced in an August 31, 2016 notification (“Notification”) that it will convene a public hearing to address its authority to regulate communications regarding unapproved uses of approved or cleared drugs and medical devices. The public hearing …
By David C. Gibbons & Jeffrey N. Wasserstein – The United States Court of Appeals for the Seventh Circuit recently issued an unpublished Opinion in United States v. LeBeau, No. 16-1289, 2016 WL 3619838 (7th Cir. July 5, 2016), a case in which the pro se …
By David C. Gibbons & Jeffrey N. Wasserstein – The most recent assault on FDA’s regulation of off-label promotion came from Congress. In a recent letter to the Secretary of the Department of Health and Human Services (HHS), the House Committee on Energy and Commerce told …
By David C. Gibbons & John R. Fleder – The Second Circuit has issued an interesting new opinion that suggests liability under the federal False Claims Act (FCA) cannot attach to at least certain types of off-label promotion. While many of the interesting sections of the …
By David C. Gibbons & John R. Fleder – On March 8, 2016, Amarin Pharma, Inc. (“Amarin” or “the Company”) and FDA filed a proposed Stipulation And Order Of Settlement (“Proposed Settlement Order”) with Judge Paul Engelmayer in the U.S. District Court for the Southern District of …
By David C. Gibbons & Jeffrey N. Wasserstein – Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) announced today that it had reached agreement with FDA to settle its First Amendment challenge regarding the promotion of its drug, EXPAREL. As we discussed in a previous post, Pacira …
This January, the American Conference Institute (“ACI”) will hold a forum to discuss the rapidly evolving legal and regulatory space for promotion of drugs and devices. The two-day meeting (with an opportunity for an extra half-day mock PRC) will be held in Philadelphia, Pennsylvania beginning …
By David C. Gibbons & Anne K. Walsh – Background In a previous post we described the recent challenge by Pacira Pharmaceuticals, Inc. (“Pacira”) to FDA’s authority to restrict a manufacturer’s promotional activities. See Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015). Pacira’s allegations …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features an analysis of the recent case of Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. May 7, 2015), written by Hyman, Phelps & McNamara, P.C. attorneys David C. Gibbons and Jeffrey N. …
By David C. Gibbons & Anne K. Walsh – In the wake of what industry is touting as Amarin’s First Amendment victory (read our Amarin posts here and here), Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) filed a suit raising similar claims in the same district …
By David C. Gibbons – An August 28, 2015 letter to Judge Paul Engelmayer, U.S. District Court for the Southern District of New York, from the attorneys representing Amarin, Inc. (“Amarin”) indicated that the parties on both sides of Amarin Pharma, Inc. v. FDA, No. 15-3588 …
By Dara Katcher Levy – Last Friday, FDA issued the latest in a series of draft guidance documents (here and here) that address alternate ways companies can disclose risk information in consumer-directed print Rx drug promotion. The most significant difference between the 2015 and 2004 draft …
