Judge strikes down prescription drug importation law in Maine | Calif. bill would require drugmakers to disclose pricing process of high-cost meds | Group seeks FDA ban of certain antifungal tablets
February 25, 2015
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Judge strikes down prescription drug importation law in Maine
A 2013 law that permits Maine residents to purchase prescription medications by mail from Australia, Canada, New Zealand and the U.K. infringes on the federal law limiting drug imports from other countries for personal use, U.S. Chief District Judge Nancy Torresen ruled Monday. The ruling, which stemmed from a lawsuit filed by pharmacy groups against the state, nullifies the law. Bangor Daily News (Maine) (free registration) (2/24) Share: Email
Calif. bill would require drugmakers to disclose pricing process of high-cost meds
California Assembly Member David Chiu introduced a bill that would require pharmaceutical companies to report their operational expenses and profits for drugs that cost more than $10,000 a year. Under the proposal, costs that would have to be reported include manufacturing, research and development, and clinical trial and marketing expenses. The figures would be submitted to the state's Office of Statewide Health Planning and Development and later be posted publicly online. The Wall Street Journal (tiered subscription model)/Pharmalot Blog (2/24) Share: Email
Group seeks FDA ban of certain antifungal tablets
The consumer safety advocate group Public Citizen is urging the FDA to prohibit the use of ketoconazole tablets as a treatment for fungal infections because of liver damage risks. The agency restricted the use of the tablets in July 2013, but the group seeks the removal of all oral versions of the medication from the market. Fox Business/The Associated Press (2/24) Share: Email
Measles infection tally reaches 154, CDC reports
CDC officials announced that the number of measles cases in the U.S. has reached 154 in 17 states and Washington, D.C. More than three-quarters of the cases are tied to the California theme park outbreak, and a majority of the patients had not been vaccinated, according to the CDC. HealthDay News (2/23) Share: Email
Poll: 78% of Americans support mandatory immunizations
Data from a Reuters/Ipsos survey showed 78% of respondents agreed that all children should receive mandatory immunizations unless the vaccines pose adverse health risks. Data also show 71% of those surveyed support school suspensions for unvaccinated children during a disease outbreak. Reuters (2/24) Share: Email
The Key To Positive Cash Flow
Every business is cyclical with cash flow ups and downs. The key is to find a way to keep the cash coming in as predictably as possible. Seem impossible? Well it's not. There are systems and processes that make it easier to collect the cash you've earned so your small business can grow. Learn how these small-business owners set up their businesses for success.

Global FocusSponsored By
Merck permits low-cost sale of pediatric HIV drug in poor countries
Merck & Co. signed a licensing agreement with the Medicines Patent Pool allowing the low-cost sale of its pediatric HIV drug raltegravir in poor countries with the highest burden of disease. The agreement means that generic manufacturers and other companies can produce low-cost pediatric versions of the drug. Reuters (2/24) Share: Email
Building Workplace Trust 2015
Interaction Associates' 6th annual research study tracking trust on the job, Building Workplace Trust, is out, and more than half of employees surveyed give their organizations low marks for trust and leadership. Yet this year's findings again point to how high trust leads to better outcomes and financial results — and even boosts innovation.

Food & Dietary SupplementsSponsored By
Federal report IDs sources of common foodborne illnesses
Beef and vegetable row crops were behind 82% of E. coli O157 illnesses in the U.S. between 1998 and 2012, according to a report by the Interagency Food Safety Analytics Collaboration. Seventy-four percent of Campylobacter infections were linked to dairy products or chicken, while 81% of listeria cases were attributed to fruits or dairy, according to the report. Reuters (2/24) Share: Email
Undeclared milk and Yellow No. 5 prompt recall of sandwich wraps
Sun Dried Tomato, Spinach Flavored and Chipotle sandwich wraps were pulled by El Popocatepetl because they may contain milk and Yellow No. 5 not declared on the label. The 8-inch wraps were distributed to stores in Illinois, mainly in the Chicago area. Food Poisoning Bulletin (2/24) Share: Email
Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

Medical DevicesSponsored By
FTC cracks down on melanoma risk-detection apps with unsupported claims
The Federal Trade Commission has taken action against the marketers of the MelApp and Mole Detective mobile applications for claiming that the apps could detect early signs of melanoma when there is no evidence to support those claims. Some of the app marketers have reached an agreement with the agency to stop making unsupported medical claims, but two additional marketers of Mole Detective have refused to settle. Health Data Management (2/24) Share: Email
Laser delivery system for Cynosure's dermal repair device cleared by FDA
The 532 nm Laser Delivery System, developed by Cynosure, has obtained clearance from the FDA. The system, which removes yellow, orange and red tattoo ink more efficiently, works with the firm's dermal repair device, PicoSure, which is used to treat acne scars, wrinkles, benign pigmented lesions and tattoos. The product is expected to be available in the second quarter. FDAnews (2/25) Share: Email
The IDC Market Spotlight on Network Automation and Agility
The arrival of virtualization, cloud computing, and mobility has strained data center networks—and IT staff—like never before. This Market Spotlight explains how data center network fabrics provide a foundation for automated provisioning, configuration, and management of network-based services in a new era of IT agility. Download now.

FDLI Items
What were the top food and drug cases of 2014? Which cases should you watch in 2015? Attend the FDLI Annual Conference to find out
Published for the sixth consecutive year, Top 20 Cases brings together more than two dozen experts in the field to identify and analyze the most important food and drug cases of 2014, and the cases to watch in 2015. This e-book explains the practical impact of the year's most significant cases on food and drug law stakeholders and describes important settlements and administrative actions. All 2015 FDLI Annual Conference registrants receive the publication free and can then attend a session devoted to the legal and practical impact of these critical-decision cases. Register for the Annual Conference now and receive your copy of Top 20 Cases as a complimentary download! Share: Email
Follow FDLI on Twitter
Follow our Twitter account (@foodanddruglaw) to get the latest announcements about FDLI events, publications and membership, as well as current news in the world of food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. Start keeping up with us on Twitter today! Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Assistant General Counsel/Senior Corporate Counsel - Healthcare Law GroupGenentech94080, CA
Clinical Trials Agreements Specialist (209955)The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc.Rockville, MD
Associate Director, Compliance & Ethics, US Operations Ops IIBristol-Myers SquibbPlainsboro, NJ
Global Counsel - Advertising and PromotionsMylan Inc.Washington, DC
Employment CounselGileadFoster City, CA
Product Patent AttorneyGileadFoster City, CA
Junior to Mid-Level FDA AssociateMorgan LewisWashington, DC
Vice President, Global Legal AffairsThe U.S. Pharmacopeial ConventionRockville, MD
Manager, Business ConductGileadFoster City, CA
Associate General Counsel Business LawTakeda Pharmaceuticals Cambridge, MA
Click here to view more job listings.
The great thing in the world is not so much where we stand, as in what direction we are moving."
-- Oliver Wendell Holmes Sr.,
physician and writer Share: Email
Learn more about FDLI ->About FDLI | Join FDLI | Conferences | Publications
Subscriber Tools
Please contact one of our specialists for advertising opportunities, editorial inquiries, job placements, or any other questions.
Editor:  Lisa Gough
Advertising:  Meryl Harold
  P: 202.407.7828
Jobs Contact:  Elizabeth Stack

Download the SmartBrief App  iTunes / Android
iTunes  Android
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2015 SmartBrief, Inc.®
Privacy policy |  Legal Information