Dec 4, 2012
FDA defense in lawsuit over food safety law: It's complicated
In an effort to fend off a lawsuit trying to force faster implementation of the Food Safety Modernization Act (FSMA), the US Food and Drug Administration (FDA) said it takes time to develop the complex regulations the law demands, according a Food Safety News (FSN) report today. The FDA on Nov 30 filed a motion for dismissal of the suit, which was filed this past summer by the Center for Food Safety and the Center for Environmental Health, FSN reported. The FDA filed drafts of four of the major FSMA rules with the White House Office of Management and Budget (OMB) a year ago, and they have been stuck there ever since, the story noted. Consumer advocates have speculated that election-year politics caused the delay. In their dismissal motion, FDA lawyers wrote, "The enormity and scope of the task given to FDA cannot be overstated." They said the agency is tasked with building a new preventive food safety system with rules that must cover $450 billion worth of domestic and imported foods and hundreds of thousands of food facilities. The lawyers argued that getting the rules right is more important than meeting statutory deadlines. The rules under review at OMB would set safety standards for produce, require preventive controls for food and animal feed, and set up a foreign-supplier verification program. The agency sent a fifth draft rule regarding third-party audits to OMB for review last week, the story said.
Dec 4 FSN story
Norovirus infections spike in England, Wales
The number of norovirus infections in England and Wales is 64% higher than at this point last year, the UK's Health Protection Agency (HPA) said in a statement today. Officials aren't sure what's driving the spike in infections. Norovirus activity levels are unpredictable, but the season typically runs from October to April. So far 2,313 cases have been reported, compared with 1,412 at this time last year. The HPA said lab-confirmed cases represent only a small portion of disease activity and estimated that there are 288 unreported cases for every confirmed case. The HPA reported one encouraging norovirus marker: The number of hospital norovirus outbreaks declined between the 2 weeks ending Nov 25 and the 2 weeks ending Dec 2.
Fraunhofer awarded NIAID anthrax vaccine contract
Fraunhofer Center for Molecular Biotechnology, based in Newark, Del, announced yesterday that it has been awarded a $1.76 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop technology to support next-generation anthrax vaccines. In a press release, the company said the contract is worth up to $9.9 million, depending on the options exercised. The contract covers advanced development of vaccine components and technologies that boost the immune response against an intentional or naturally occurring exposure to Bacillus anthracis, which causes anthrax. Deliverables include biomass generation, agro infiltration, protein purification, and formulation development. The option includes conducting a phase 1 clinical trial. The company's partner in the project is Isconova AB, a Swedish technology company that specializes in developing and producing vaccine adjuvants.
Dec 4 BusinessWire press release
Report: Vaccine-derived polio virus spread from Pakistan to Afghanistan
Two Afghan children have been paralyzed by a vaccine-derived poliovirus that spread from neighboring Pakistan, according to the Express Tribune, a Pakistani newspaper. The story referred to the virus as "Sabin Like (2)," which, according to ProMEDmail, means vaccine-derived poliovirus (VDPV) type 2. The two cases were reported in Panjwai and Spin Boldak districts of Afghanistan's Kandahar province, the newspaper said. Health officials said genetic sequencing showed that the virus originated in the Killa Abdullah district of Pakistan's Balochistan province, according to the story. Another Pakistani newspaper, Dawn, said 10 cases of the same strain have been reported in two Balochistan districts in the past 3 weeks. A Pakistan government official told Dawn that extremists in Balochistan have been warning parents there not to get their children vaccinated. Officials told the Express Tribune that the vaccine-derived virus can strike children who have an extremely poor polio immunization record, which is a common situation in Balochistan. The newspaper said a World Health Organization team led by polio eradication expert Mohammed Mohammedi is in Balochistan and has asked the provincial government to stage three emergency polio immunization campaigns in three districts over the next month. Mohammedi said the first campaign is scheduled for Dec 10. Since 2006, the story said, vaccination teams have repeatedly missed an estimated 50,000 children in Killa Abdullah.
Dec 2 Express Tribune story
Dec 2 Dawn story
Related ProMED-mail post