FDA delays decision on NPS Pharma's hypoparathyroidism drug | Relypsa submits hyperkalemia drug candidate for FDA review | Mylan loses bid to market generic of Pfizer's cancer drug Sutent
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October 24, 2014
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
FDA delays decision on NPS Pharma's hypoparathyroidism drug
The FDA postponed by three months its decision on NPS Pharmaceuticals' marketing application for Natpara as a treatment for hypoparathyroidism, saying it needs more time to evaluate additional material. The agency also asked the firm to submit a plan explaining the drug's risks and how to mitigate them. A decision is now expected by Jan. 24. Yahoo/The Associated Press (10/23) Share: Email
Relypsa submits hyperkalemia drug candidate for FDA review
Relypsa has submitted its experimental drug Patiromer for FDA review for the treatment of hyperkalemia, which affects patients with chronic kidney disease. Relypsa CEO John Orwin said the drug could be approved next year. American City Business Journals/San Francisco/BiotechSF blog (10/22) Share: Email
Mylan loses bid to market generic of Pfizer's cancer drug Sutent
A U.S. district court ruled that Mylan infringed on Pfizer's patent on the cancer drug Sutent after attempting to market a generic version. Pfizer owns the rights to the drug, which is approved for pancreatic and gastrointestinal tumors as well as advanced kidney cancer, until 2021. Reuters (10/23) Share: Email
FDA sends warnings to online sellers of bogus Ebola cures
Three companies received warning letters from the FDA for making false claims about Ebola treatments online, and prosecutions and property seizures could follow. FDA National Health Fraud Coordinator Gary Coody said worthless products may give people a false sense of protection that delays diagnosis and health care. Southern Methodist University's Nathan Cortez said the crackdown is a "public shaming" strategy that serves as a warning for other potential sellers of shams. National Public Radio/Shots blog (10/23) Share: Email
Attorney: FDA wrong to change generic labeling rule
A proposed rule to allow generic-drug makers to independently update safety warnings is a bad idea because it would make makers of generic drugs act like brand-name drugmakers and prices will increase, Kirkland & Ellis attorney Jay Lefkowitz said in this interview. In addition, the draft goes against current law. The FDA "can't promulgate a regulation that is in conflict with the plain text of a statute," Lefkowitz said. The Wall Street Journal (tiered subscription model)/Pharmalot blog (10/23) Share: Email
Global Focus
Bayer's Xarelto wins provisional OK to prevent blood clots in U.K.
Draft proposals were published by the U.K. National Institute for Health and Care Excellence recommending Bayer's Xarelto, or rivaroxaban, as an option for preventing blood clots in patients who have had a heart attack caused by cardiac blood vessel narrowing or blockage. The guidance does not cover patients with unstable angina, but only those with severe acute coronary syndrome resulting in cardiac biomarkers being released into the blood. PharmaTimes (U.K.) (10/23) Share: Email
Food & Dietary Supplements
Several hot peppers pulled by Giant Food due to salmonella risk
Giant Food Stores has recalled red cherry hot, Anaheim, serrano and finger hot peppers because of possible salmonella contamination. The affected products, produced by Bailey Farms and sold at Giant Food on Oct. 9 and thereafter, bear the PLU number 4691. The move expands Bailey Farms' recent recall of serrano peppers. Food Poisoning Bulletin (10/23) Share: Email
Medical Devices
Study finds improvements in FDA's device-review programs
The FDA took an average of 297 days to approve high-risk medical devices under the premarket approval application program in 2012, the agency's fastest review time over the last decade, according to a California Healthcare Institute analysis. Although review times for 510(k) clearance applications remain slow, the FDA has successfully reduced backlogs in both its premarket approval and 510(k) clearance programs. Regulatory Focus (10/23) Share: Email
Crossing catheter from ReFlow wins FDA nod
The FDA has cleared ReFlow Medical to market its Wingman35 crossing catheter, which the company said is already available in California vascular clinics. The catheter, which is used together with steerable guidewires, has a beveled guide-tip that allows doctors to cross lesions within blood vessels. The device was also given CE Mark approval last month. MassDevice.com (Boston) (10/23) Share: Email
FDA OKs study of Gynesonics' uterine fibroid technology
The FDA has granted Gynesonics an investigational device exemption for a pilot study of its VizAblate technology, which features an ultrasound probe to help doctors access uterine fibroids and deliver ablation therapy using radiofrequency energy. The study will determine whether the device is safe and effective in treating excessive menstrual bleeding in patients with symptomatic uterine fibroids. MassDevice.com (Boston) (10/23) Share: Email
FDLI Items
Brussels spotlight panel: Public Health: The Policy Issue Permeating the Regulatory Landscape
Join us in Brussels, Belgium on Nov. 13-14 for our Europe vs. U.S. Food, Drug, Device & Tobacco Regulation & Policy: Emerging Issues and Comparative Analysis conference. Our public health panel will focus on high-level analysis of public health policy issues and discuss how agencies in the U.S. and Europe enforce proactive policies and enforcement efforts. The following professionals will be speaking:
  • Ole Döring, Ph.D., director, Sino-German Network for Public Health and Bioethics, Charité Medical University, Berlin and Karlsruhe Institute for Technology, Germany
  • Joyce ter Heerdt, assistant general counsel, Johnson & Johnson
  • Aude Mahy, senior associate, Loyens & Loeff
  • James N. Czaban, chair, FDA Practice Group, Wiley Rein LLP
Click here to register!
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Save the date! FDLI’s 2015 Annual Conference is on April 20-21!
More than 700 food and drug law community members -- experts from the federal government, industry, private sector bar, consulting organizations and academia -- gather for two days of keynote addresses, networking and advanced education sessions. Our participants attend our Annual Conference to hear directly from FDA leadership, advance their careers by staying current in their fields, network with colleagues and potential business partners, and engage in hot-topic discussions and debate. Mark your calendars! You won't want to miss it. Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Associate Manager, Regulatory AffairsStrykerMahwah, NJ
Mid-Level Pharmaceutical/Medical Device Regulatory AssociateArnold & Porter LLPWashington, DC
Counsel I – Clinical Contracts Gilead SciencesFoster City, CA
Director, Antibiotics and Innovation ProjectThe Pew Charitable TrustsWashington, DC
Director of LitigationCenter for Science in the Public InterestWashington, DC
Associate General CounselPatient-Centered Outcomes Research InstituteWashington, D.C , DC
Associate - Food and Drug Keller and Heckman LLPWashington, DC
Paralegal, Legal-RegulatoryConfidentialPiscataway, NJ
Assistant General Counsel, Regulatory FDA Cardinal HealthColumbus, OH
Click here to view more job listings.
Live in each season as it passes; breathe the air, drink the drink, taste the fruit, and resign yourself to the influences of each."
-- Henry David Thoreau,
American writer and naturalist Share: Email
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