Drugs & Biologics

• Don't hold shippers responsible for illegal Rx drug sales
  The Justice Department is wrong to go after UPS and FedEx for their role in the shipping of illegal sales of painkillers by online pharmacies, according to this editorial. The Controlled Substances Act specifically protects "common or contract carriers" who are otherwise acting lawfully. The Wall Street Journal (3/3)

• FDA to scrutinize 30 compounders in 2 months
  The FDA plans to inspect around 30 drug compounders in the next two months as part of heightened efforts following a deadly meningitis outbreak tied to compounded drugs. The pharmacies mainly produce sterile drugs for health care providers across the country, FDA spokeswoman Erica Jefferson said. Bloomberg Businessweek (3/1)

• FDA staff: Calcitonin salmon may carry cancer risk
  A link between osteoporosis treatments containing calcitonin salmon and cancer risk is possible, according to briefing documents from FDA staff reviewers. The reviewers raised questions about the drugs' usefulness in preventing bone breaks due to osteoporosis in postmenopausal women, the reviewers said. An FDA panel is set to discuss the products on Tuesday. Reuters (3/1)

• Novartis' Ilaris wins EU approval for acute gouty arthritis
  Novartis obtained approval from the European Commission to market Ilaris in adult patients with acute gouty arthritis who can't tolerate current treatment options. Ilaris, an interleukin-1 beta inhibitor, is already cleared for cryopyrin-associated periodic syndromes. Reuters (3/1), RTT News (3/1)

• British pharma asks for delay in pricing system
  A group of British drug wholesalers, concerned about supply chain issues, asked for a one-month grace period before the introduction of a new value-based pricing system. The new program will replace a 55-year-old system that allowed the industry to set its own prices -- under a cap -- and negotiate every five years. PharmaTimes (U.K.) (3/1)

• Europe supports push to cure rare conditions
  The European Commission will spend about $187 million on 26 research projects on rare diseases, involving research teams from 29 countries. The goal is to discover effective treatments for a metabolic, immune and cardiovascular disorders, among others. PharmaTimes (U.K.) (3/1)

Food & Dietary Supplements

• China may create single food, drug regulator
  China's parliament is expected to approve a combined food and drug regulatory agency as part of a broader restructuring. The plan was still being finalized and could end up focusing solely on food safety. Oversight currently is shared by as many as 13 agencies, including the State Food and Drug Administration. South China Morning Post (Hong Kong) (free registration) (3/4), The Wall Street Journal (3/3)

• Sequester to disrupt USDA's meat inspection, Vilsack says
  USDA Secretary Tom Vilsack said he must furlough meat inspectors due to across-the-board budget cuts under the sequester, and the inspection process will be disrupted. "There is not enough flexibility in the sequester language for me to move money around," Vilsack said. FoodSafetyNews.com (3/4)

Medical Devices

• Mercator gains EU approval for micro-infusion catheters
  Mercator MedSystems has earned the CE mark to market its Cricket and Bullfrog micro-infusion catheters in Europe. The devices already have U.S. approval. The devices are used to deliver drugs straight to deep tissue through blood vessel walls, keeps the injected agent from spreading throughout the body while also allowing for a high concentration near the targeted area. MedGadget.com (3/1)

Tobacco

• CDC: 1 in 5 adult smokers have tried e-cigarettes
  The number of U.S. adult smokers who have tried electronic cigarettes rose from about 10% in 2010 to about 21% in 2011, according to a CDC study released on Thursday. Current smokers were more likely to use the devices than nonsmokers, researchers said. "There is still a lot we don't know about these products, including whether they will decrease or increase use of traditional cigarettes," CDC director Dr. Tom Frieden said. U.S. News & World Report/HealthDay News (2/28)

Hot Topics

Top five news stories selected by FDLI SmartBrief readers in the past week.

• FDA stops pediatric trials of Amgen drug after teen death (Reuters)

• FDA has plenty of ways to cut spending, with or without sequester (Forbes)

• Analysis: Recall could make FDA more cautious about biosimilars (Forbes)

• Former FDA chief: Reform rules for clinical trials (Bloomberg)

• USPSTF: Postmenopausal women should not take vitamin D, calcium (Family Practice News)

• Results based on number of times each story was clicked by readers.

FDLI Items

• 2013 conference calendar -- speak, register & save the dates!
  There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
  • Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
  • Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
  • FDLI Annual Conference | April 23-24 | Washington, D.C.
  • FDLI International Conference | June 6-7 | Beijing, China. New date!
  • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
  • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Location TBD
  • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
  • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
  

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SmartQuote

The person whose doors I enter with most pleasure, and quit with most regret, never did me the smallest favor." --William Hazlitt, British writer and philosopher