Drugs & Biologics

• FDA pick coming soon, Obama spokesman says
  President Barack Obama will announce his nominee for FDA commissioner in the next few days, White House spokesman Robert Gibbs said. The agency faces mounting pressure to address product safety, including recent cases of salmonella contamination in peanuts. Obama's choice, who would take over for interim chief Dr. Frank Torti, has to be confirmed by the Senate. Reuters (1/30)

• FDA advisers recommend discontinuing 2 painkillers
  An FDA panel voted 14-12 in favor of withdrawing pain drugs Darvon and Darvocet from the U.S. market, citing efficacy concerns and safety risks. An official with Xanodyne Pharmaceuticals, which makes versions of both medicines, said the firm intends to meet with the FDA to discuss the decision "and come up with a plan on how to move forward." CNNMoney.com/Dow Jones Newswires (1/30)

• U.S. appeals court allows lawsuits over Pfizer's Trovan
  The U.S. Court of Appeals for the 2nd Circuit in New York reinstated two lawsuits brought by Nigerian families who claim that Pfizer used their children in an unlawful study of Trovan, an investigational antibiotic. A lower-court judge had thrown out the cases, saying they should be filed in Nigeria. Pfizer characterized the appeals court's decision as "only a procedural ruling" and said it "remains confident that it will prevail in these cases." The Washington Post (1/31)

• Panel's ruling may affect market for anti-clotting drugs
  An FDA committee of independent experts is scheduled Tuesday to decide whether to endorse prasugrel, an anti-clotting medicine from Daiichi Sankyo and Eli Lilly and Co. The recommendation may influence the market for such treatments and indicate how the government will define standards for clearing risky, high-return drugs. FDA staff backed prasugrel's approval but suggested that the agency limit the product's use in people who have suffered a stroke or are older than 75. The Wall Street Journal (tiered subscription model) (2/1), Reuters (1/30)

• White House may permit cheaper medicines from Canada
  The Obama administration is looking to overturn a policy on prescription-drug imports to allow more affordable Canadian medicines into the U.S. The change would provide patients, particularly older people, with cheaper options, but concerns remain about counterfeit medications tied to stores with access to foreign pharmaceuticals. XETV-TV (San Diego) (1/31)

• Other News

• Takeda wins FDA approval for heartburn treatment Kapidex
  Bloomberg (1/30) Chicago Tribune (1/30)

• Other News

• Abbott gets FDA warning letter over marketing materials for epilepsy drug Depakote
  CNNMoney.com/Dow Jones Newswires (1/30)

Biotechnology

• Calif. stem cell agency defers release of $58M in research grants
  The California Institute for Regenerative Medicine's board decided to postpone until March the release of $58 million in research grants, which have been approved for use in training scientists at Stanford University and five other San Francisco-based institutions. The agency cited unfavorable economic conditions and a weak credit market for the delay. San Jose Mercury News (Calif.)/The Associated Press (free registration) (1/31)

Food & Dietary Ingredients

• Use of approved irradiation remains rare
  The U.S. government says irradiating food is safe, and many experts think it could prevent outbreaks such as the salmonella now tied to tainted peanut butter. Spices and some imported products, such as mangoes from India, are among items in supermarkets that are commonly treated with radiation. NYTimes.com (2/1)

Featured Content

Medical Devices

• Alsius faces patent-infringement lawsuit from Zoll Medical
  Zoll Medical Corp. is filing a case against Alsius Corp. for allegedly infringing on two patents tied to a device designed to regulate body temperature with the aid of a catheter placed in the bloodstream. Alsius said it is evaluating the case and is secure in its intellectual property. Forbes/The Associated Press (1/30)

• AdvanDx gets FDA approval for blood test
  The FDA has granted 510(k) clearance to AdvanDx for a test designed to detect Gram-negative pathogens, such as E. coli and P. aeruginosa, from blood samples within a few hours. The PNA FISH test can also be used to detect methicillin-resistant Staphylococcus aureus infections. Mass High Tech (Boston) (1/30)

• Cogmedix meets FDA quality-control requirements
  Cogmedix said it has complied with the FDA's requirements for medical-device manufacturing, quality-control procedures and finished products. Cogmedix, a subsidiary of Coghlin Cos., worked with Accelerate, a consulting company, in order to meet the agency's "Quality Systems" regulations. Worcester Business Journal (Mass.) (1/30)

Hot Topics

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

• Pfizer to pay $2.3B settlement over Bextra promotion (The Wall Street Journal (tiered subscription model))

• Mercury found in high-fructose corn syrup (Forbes)

• KV to halt manufacturing, issue voluntary recall (Forbes)

• FDA: Processor found salmonella, shipped peanut butter anyway (The Washington Post)

• Vitamin D linked to cognition (ScienceDaily)

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

FDLI Items

• Save $200! Register for both Introduction to Drug Law and Regulation, Feb. 3 and 4, and Waxman-Hatch, Feb. 5 and 6. Hurry!
  Introduction to Drug Law provides the essential elements of the laws and regulations affecting the drug industry. It is organized to provide an overview of FDA, and presents an outline of the history of and details specific to drug regulation: new and abbreviated drug approvals, marketing, imports/exports and more. On Feb. 5 and 6, discuss the context for understanding the intention of Waxman-Hatch, and what lessons have been learned that inform the future of balancing competing interests. The program will delve into the specifics of forfeiture, patent exclusivity, economics, legislation and citizen petitions. Register for both programs online. Register by fax.

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