NEWS SCAN: FDA funds for food safety, antibiotic resistance tools, pneumococcal vaccine for adults

Nov 16, 2011

House-Senate compromise boosts FDA funds for food safety
A spending bill approved by a House-Senate conference committee this week would increase the Food and Drug Administration's (FDA's) budget for fiscal 2012 by $50 million, with the aim of funding the new food safety law and improving bioterrorism preparedness, according to a report by Food Safety News (FSN). The bill gives the FDA $2.5 billion, which is $334 million more than what was approved by the House in June, the story said. Also included is $1 billion for the US Department of Agriculture's Food Safety and Inspection Service—enough to maintain its current workforce and $32 million more than in the House measure, FSN reported. The additional FDA funds are to be spent on implementing the new FDA Food Safety Modernization Act and continuing FDA's efforts to improve medical countermeasures against bioterrorist attacks, said the Alliance for a Stronger FDA, an advocacy group, which praised the bill in a statement yesterday. The House is scheduled to vote on the compromise bill tomorrow, according to a Nov 15 report in The Hill. That report said the $128 billion bill conforms with the debt-ceiling deal that the two parties forged in August, but a "substantial number" of House conservatives are likely to oppose it as too expensive. The bill also includes funds for the departments of Commerce, Housing and Urban Development, Justice, and Transportation, according to the Washington Post. The $50 million increase in funding for the FDA, while possibly surprising in a cost-cutting climate, is small in comparison with a 2010 Congressional Budget Office estimate of the cost of implementing the new food safety law: about $1.4 billion over 5 years.
Nov 16 FSN report
Nov 15 The Hill report
Nov 15 Alliance for a Stronger FDA release
Dec 23, 2010, CIDRAP News report on challenges in implementing the food safety law

Group launches antibiotic resistance tracking tools
A nonprofit group based in Washington, D.C., today unveiled a set of interactive Web-based maps that track antibiotic use, which shows that southeastern states have the nation's highest levels of antibiotic dispensing. The mapping tool is part of the Center for Disease Dynamics, Economics and Policy's (CDDEP's) "Extending the Cure" project, which is aimed at addressing the growing problem of antibiotic resistance. The maps draw from several microbiological surveillance databases. The group said overall antibiotic dispensing decreased 12% between 1999 to 2007, though prescribing rates for fluoroquinolones rose by 49% during that period. The five states with the highest antibiotic use are West Virginia, Kentucky, Tennessee, Louisiana, and Alabama. Residents of the top two states, for example, take about twice as many antibiotics per capita as those in Oregon and Alaska, CDDEP said today in a press release. It said other regions of the country have higher-than-average use of antibiotics, as well.
Nov 16 CDDEP press release
CDDEP antibiotic resistance map
On Nov 14 the group also introduced a tool called the Drug Resistance Index (DRI), which is designed to track changes in antibiotic effectiveness. It described the index in BMJ Open. For example, hospitals can use the DRI to track resistance levels in their facility and the effectiveness of antibiotic stewardship and infection control interventions. The group's launch of the new tools coincides with a week-long "Get Smart About Antibiotics" campaign led by the US Centers for Disease Control and Prevention.
Nov 14 BMJ Open report

FDA vaccine advisers support Prevnar pneumococcal vaccine for adults
The FDA's vaccine advisory group today voted that immunogenicity data for Pfizer's 13-valent pneumococcal conjugate vaccine (13vPnC, or Prevnar 13) are adequate to support accelerated approval for adults age 50 or older and that available data suggest that the vaccine is safe in that age-group. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted affirmatively on both issues 14 to 1, and the FDA typically accepts its recommendations. The vaccine, made by Pfizer, is currently recommended for infants and young children, whereas the 23-valent polysaccharide vaccine—Pneumovax, made by Merck—is indicated for children older than 2 and older adults. Currently, the only adults recommended to receive the pneumococcal vaccine are those age 65 and older and younger adults with certain risk factors. An FDA briefing document prepared for the advisory panel said the medical rationale for vaccination is an increased risk of pneumonia that starts at age 50. It said Prevnar 13 appears to provide longer-lasting and better protection against community-acquired pneumonia. During the VRBPAC meeting, Pfizer representative said they expect to complete an 85,000-person study in the Netherlands to assess the vaccine in adults in 2013. After the vote, VRBPAC members said they look forward to additional studies on efficacy measures for the vaccine and on how long protection lasts.
Nov 16 VRBPAC briefing report

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