By Kurt R. Karst – For several years now we have been following instances in which FDA designated, and later approved, a drug (including a biological product) as an “orphan drug” on the basis that it is not the “same drug” as a previously approved product …
By Kurt R. Karst – Ever since FDA Commissioner Dr. Robert M. Califf's February 2016 call for a sweeping review of FDA policies concerning opioids (in response to growing pressure from Congress), the Agency has been on a tear to meet that call with new policies and requirements. There's the recent announcement …
By Ricardo Carvajal – That’s our take-away from FDA’s recent public meeting on the implementation of FSMA’s import provisions and the associated regulations (FSVP, VQIP, and Accredited Third Party Certification). Several comments made at the meeting suggest that many importers may still be unaware of the advent …
On March 31, 2016, from 10:00 AM – 12:30 PM, the American University Washington College of Law (Washington, D.C.) will hold a symposium to discuss recent developments in off-label promotion, including the recent Amarin case (see our previous post here). The symposium, titled “Drug Promotion …
By Alexander J. Varond – FDA’s breakthrough therapy designation (BTD) program has been, by all accounts, a popular program. Sponsors, looking to gain extra support from the Agency, shorten review times, and signal to investors that FDA views their preliminary clinical evidence favorably, have submitted over …
By Mark I. Schwartz – One of the pre-eminent rules in QSR and cGMP compliance is to document one’s activities. In the eyes of FDA, the “failure to document” is often equated with the failure to perform the underlying regulated activity. FDA takes this position principally …
By David C. Gibbons & Jeffrey N. Wasserstein – On March 16, 2016, the Feinstein Institute for Medical Research, located in Manhasset, New York, (“Feinstein”) entered into an agreement with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) to pay $3.9 …
By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”) has released its final guidelines for prescribing opioids for chronic pain. CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Mar. …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Columbia (Judge Rudolph Contreras) issued a 33-page Memorandum Opinion in a case stemming from a Complaint filed in June 2015 by Ferring Pharmaceuticals Inc. (“Ferring”) against FDA challenging the Agency’s …
By Ricardo Carvajal & JP Ellison – In a decision of significance in the realm of food additive regulation, the U.S. District Court for the Northern District of California dismissed a lawsuit targeting coffee-creamer products containing partially hydrogenated oil (PHO) on preemption grounds. The complaint – …
By Melisa M. Moonan – On March 4, 2016, FDA published a Federal Register Notification titled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” (March 2016 notification). This notification announces the establishment of a …
By James C. Shehan & Kurt R. Karst – On March 10, 2016, FDA released a draft guidance interpreting the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). This provision, at BPCIA § 7002(e)(4), is one of a …
By David C. Gibbons & Alan M. Kirschenbaum – On March 8, 2016, CMS issued a proposed rule to test new models for payment of drugs and biologicals under Medicare Part B (“Proposed Rule”). Medicare Part B covers limited categories of drugs, including (1) those provided incident …
By Jenifer R. Stach & Wes Siegner – If you weren’t aware that the Department of Justice (DOJ) has unsafe dietary supplements on its list of enforcement priorities, you should take notice. On Tuesday March 8th, 2016 as part of National Consumer Protection Week, United States Attorney …
By James C. Shehan – More than one commentator predicted that the Federal Circuit’s decision in Amgen v. Sandoz interpreting the patent dance provisions of the Biologics Price Competition Innovation Act ("BPCIA") would be a fertile source of new litigation rather than a definitive decision laying …
