Drugs & Biologics

• Contraceptives should be on FDA's OTC list, advocates say
  Reproductive-rights advocates used an FDA hearing Thursday and Friday to press for inclusion of birth control pills in a possible increase of nonprescription drugs. "It has been a politically charged topic," said Eleanor Schwarz, an associate professor of medicine at the University of Pittsburgh. "When we keep it within the purely health-and-science realm, we understand it saves people's lives. All available contraceptives are much safer for women's health than an undesired pregnancy." Bloomberg (3/23)

• FDA allows clinical testing of Bionomics' cancer drug
  Bionomics received FDA approval to initiate a Phase I/II clinical study of experimental ovarian cancer treatment BNC105, a vascular disruption agent that attacks tumor blood vessels. The trial is expected to begin in the second quarter. Australian Life Scientist (3/26)

• Amylin and Lilly's Byetta receives expanded approval in EU
  The European Commission approved Amylin Pharmaceuticals and Eli Lilly and Co.'s twice-daily injectable Byetta as adjunct therapy to basal insulin, with or without standard drugs metformin or Actos, by Takeda Pharmaceutical. The FDA authorized the usage last year. Fox Business/Dow Jones Newswires (3/23), Bloomberg Businessweek/The Associated Press (3/23)

• Canada accelerates approval of 2 generic drugs to ease shortage
  Health Canada expedited approval of Omega Laboratories' muscle relaxant rocuronium bromide and Accord Healthcare's anti-nausea drug ondansetron to ease a nationwide shortage. "Under normal circumstances, we plan to complete market authorizations for generic drugs within six months," the regulator said. "However, to help health care providers get access to replacement supplies of drugs that they normally get from Sandoz ... we have committed to expediting all phases of the drug-review process as much as possible." Toronto Sun/QMI Agency (3/23)

Food & Dietary Supplements

• GOP presidential candidates seek less food regulation
  Food safety has not been a big issue in the Republican presidential race, with some candidates more engaged with the topic than others. Ron Paul favors raw-milk sales; Newt Gingrich said the FDA kills jobs; Rick Santorum has acted in favor of animal welfare; and Mitt Romney said regulation in general is a "hidden tax on Americans." FoodSafetyNews.com (3/23)

• In defense of "pink slime"
  "Pink slime," the lean, finely trimmed beef from Beef Products, is the subject of public outcry, but food columnist Ari LeVaux argues it is no worse than other elements of processed meat. The Department of Agriculture inspector who coined the phrase in 2002 did not find pink slime dangerous, but rather argued that it was not ground beef and should not be labeled as such. TheAtlantic.com (3/23)

Featured Content

Medical Devices

• FDA pilot would allow GHTF-audited firms to avoid reinspections
  The FDA will start on June 5 a pilot program to allow medtech firms to skip reinspections for a year, under certain conditions, if they have already undergone an audit by a Global Harmonization Task Force founding member. To join the program, companies must submit the report from their last audit within 90 days of the audit's last day. Clinica (subscription required) (3/22)

• IOM releases best practices for developing 'omics-based tests
  The Institute of Medicine has issued a set of guidelines for 'omics-based test development. Recommendations are divided into three stages: discovery, validation and assessment of clinical utility. The report, which covers tests based on genomics, proteomics, metabolomics and related fields, was requested by the National Cancer Institute after a scandal in which a researcher was accused of manipulating data. GenomeWeb Daily News (3/23)

• AdvaMed supports bill seeking expedited release of device ID rule
  A Senate bill urging the FDA to release by year-end a final rule on the creation of a unique identifier system to track implantable medical devices has gained support from AdvaMed. "We very much appreciate the senators' interest in the UDI and share their interest in ensuring the safety of medical devices," AdvaMed President and CEO Stephen Ubl said in a statement. BeckersASC.com (3/22)

• Zoll Medical nets FDA nod for X Series defibrillator
  Zoll Medical said it has obtained 510(k) clearance from the FDA to market its X Series monitor/defibrillator, which is tailored for the EMS segment. The device is about half the weight and size of competitive full-featured devices, but is more powerful and sturdy, the company said. Mass High Tech (Boston) (3/23)

Tobacco

• FDA advisers are wary of dissolvable tobacco
  An FDA advisory panel concluded that while dissolvable tobacco seems less harmful than cigarette smoking, it still has the potential to increase tobacco use. Advisers also said more research was needed. The Washington Post/The Associated Press (3/22)

Hot Topics

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

• Teva's promotional material for Copaxone prompts FDA warning (Pharmalot.com)

• FDA cites Biogen for "misleading statements" on MS drug Avonex (American City Business Journals)

• Supreme Court rejects 2 personalized medicine patents (Reuters)

• Judge compels FDA to pursue livestock antibiotics ban (The Washington Post)

• Supreme Court decision protects generics makers from lawsuits (The New York Times (tiered subscription model))

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

FDLI Items

• New Update -- Food Week, animal antibiotics controversy and more
  The March/April issue of Update Magazine is now out and can be accessed by members and subscribers online through FDLI's website. In addition to coverage from FDLI's Food Week, Suzanne O'Shea and Christin Garcia write about the controversial issue of antibiotics in animals. The authors posit that we will see an increased evaluation of approved antibiotic drugs labeled for improved feed efficiency or growth production in 2012.

Position Title Company Name Location Regulatory Attorney Confidential NJ, NJ Senior Counsel - Regulatory and Quality Assurance Compliance Procter & Gamble Cincinnati, OH Senior Corporate Attorney (Regulatory) Astellas Pharma Deerfield, IL Corporate Counsel/Senior Corporate Counsel Genentech South San Francisco, CA Manager/Senior Manager, FDA Avalere Health Washington, DC Compliance Specialist Dyax Corp. Burlington, MA IP Counsel Novo Nordisk Princeton, NJ Regulatory Scientist Morgan, Lewis & Bockius LLP Washington, DC Senior and Principal P/T Consultants Becker & Associates Consulting Nationwide, United States Manager/Associate Director US Regulatory Affairs Pfizer Madison, NJ

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