On July 8, 2019, U.S. District Court Judge Amit P. Mehta struck down a recently finalized Centers for Medicare & Medicaid Services (CMS) rulethat would have required drug pricing disclosures to be included in television advertisements for certain prescription drugs and biological products (the “Price …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 33rd iteration – is scheduled to take place from March 25-27, 2019, at the Park Lane Hotel in New York, NY. The conference is billed as the premier event to provide folks …
What is “truthful and non-misleading” in prescription drug promotion is often in the eye of the beholder. And, when it comes to enforcement, FDA is usually the arbiter. Over the years, FDA has taken on a number of initiatives and invested significant resources to better …
In its fourth enforcement letter of 2018, the Office of Prescription Drug Promotion (OPDP) takes aim at a marketed drug’s sell sheet solely on the basis of misleading efficacy claims, the first letter to do so in over 3 years. The letter, issued August 16 to …
Announced as another effort to improve patient access and address drug pricing, FDA recently finalized two guidance documents intended to facilitate better communication and negotiation with payors, formulary committees, and others: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance …
In January 2017, FDA issued two Draft Guidance documents concerning communications made by medical device manufacturers about information not expressly contained within a product’s labeling: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance for Industry [Draft] (January 2017), hereinafter …
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 …
