Report to House committee finds imbalance between FDA demands and resources
WASHINGTON The nation’s public health is at risk, as are the regulatory systems that oversee the nation’s drug and device supplies, read an FDA Science Board report presented at a House Energy and Commerce Committee hearing Tuesday.
The committee attributed the deficiencies to soaring demands on the FDA; and resources that have not increased in proportion to those demands. They conclude that “this imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public.”
“Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA,” noted Mark McClellan, former FDA commissioner and chairman of the Reagan-Udall Institute. “As the FDA Science Board report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission.”
The result of a year-long review by a distinguished panel of experts, the 300-page report concludes that the state of FDA’s scientific and regulatory programs could not be separated from the lack of resources available to support the agency’s scientific base, hire and train a broadly-capable scientific workforce, and build a sophisticated and modern information technology infrastructure.
“FDA can’t improve its science, prepare for the future, or protect American consumers without significant additional resources,” stated Don Kennedy, another former FDA commissioner and editor-in-chief of Science. “The Administration and Congress are starting now on the FDA’s FY 2009 budget and must fix this critical problem.”
Peter Barton Hutt, who served as the FDA’s general counsel in the 1970s, suggested a doubling of the agency’s $2 billion annual budget and a 50 percent increase in its staff over two years.
NPA to host Congressional lobbying day in April
WASHINGTON The Natural Products Association plans to host its 11th annual lobbying effort, Natural Products Day, April 8, the association announced Monday.
“Natural Products Day is a fun and effective way for industry members to establish and strengthen personal relationships with members of Congress,” stated David Seckman, Natural Products Association executive director and chief executive officer. “It helps legislators stay aware of issues important to our industry and to their district, and is an essential tool in gaining support for our many important initiatives. We make it easy for anyone to participate by making appointments with legislators, providing educational reference materials and thoroughly briefing participants about the issues.”
Natural Products Day helps broaden the natural products industry’s base of political support by educating members of Congress about the important role natural products play in keeping Americans healthy, and the overwhelming public benefits of preventative care, the association stated.
This year, Natural Products Day will focus around the Child Nutrition Promotion and School Lunch Protection Act of 2007, proposed by Senator Tom Harkin, D-Iowa, to redefine what foods are considered healthy to be served in schools. Also featured will be the association’s opposition to legislation limiting the availability of the popular dietary supplement DHEA, used to aid with aspects of aging. According to the position of the Natural Products Association, DHEA has been inappropriately classified as an anabolic steroid, despite the fact that it has no proven athletic performance-enhancing attributes that would lead to abuse.
Carey named nutritional expert for NuVim
PARAMUS, N.J. NuVim on Tuesday named Ruth Carey nutritional expert.
Carey has been a nutrition consultant in private practice and has been a national media spokesperson for brands like Gatorade and Lipton and has worked with brands like Ensure, Nike, The USA Olympic Committee, The Portland Trailblazers and USA Gymnastics. She has appeared on “Good Morning America,” “The Today Show” and The Food Network.
Carey will be helping to promote NuVim, a refrigerated nutrition beverage sold in half-gallon juice cartons in 2,000 supermarkets, including Shoprite, A&P, Giant Eagle, Acme, Giant and more than 300 Wal-Mart supercenters.
NuVim is fortified with NutraFlora, a prebiotic that helps maintain a strong immune system and enhances calcium absorption and digestion. NuVim also contains a level of whey protein concentrate that is known to help muscle flexibility, promote sturdy joints and improve athletic performance, the company stated.