HEALTH

FDA advocacy coalitions claim regulatory agency lacks adequate funding

BY Michael Johnsen

WASHINGTON Two coalitions that include several former Food-and-Drug-Administration commissioners announced the planned presentation of a 300-page report Dec. 3 that, in part, questions the FDA’s ability to execute against its mission—to safeguard and regulate the nation’s food, cosmetics and drug supply—given the lack of adequate funding, the coalitions announced Friday.

“The nation’s food supply is at risk, as are the regulatory systems that oversee the nation’s drug and device supplies,” stated a subcommittee of the FDA’s Science Board—a board established in 1992 by FDA to advise the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science; on formulating an appropriate research agenda; and on upgrading its scientific and research facilities to keep pace with these changes—in a report it will present Monday.

The subcommittee 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. As this new report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better,” commented Mark McClellan, former FDA commissioner and chairman of the new Reagan-Udall Institute designed to enhance FDA’s readiness for future scientific challenges.

“That FDA needs more resources should be obvious,” added Jane Henney, former FDA commissioner and current senior vice president and provost for health affairs at the University of Cincinnati. “What makes this report so extraordinary is the qualifications of the individuals who wrote it, the year-long process to put it together, and the depth of analysis that supports its conclusion: FDA’s mission is at risk for lack of support for its scientific capabilities.”

The result of a year-long review by the Science Board subcommittee, the 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 former FDA commissioner and editor-in-chief of Science. “Congress is negotiating FDA’s FY 2008 [the current year] budget right now and can start to fix this critical problem.”

The two coalitions—the FDA Alliance and the Coalition for a Stronger FDA—formed in 2006 in response to the unmet resource needs of the FDA and the potential threat that poses to America’s health, safety and commerce. Both the FDA Alliance and the Coalition for a Stronger FDA bring together consumer and patient groups, professional organizations, trade associations, companies and individuals. More about each group can be found on their respective websites: www.StrengthenFDA.org (FDA Alliance) and www.FDACoalition.org (Coalition for a Stronger FDA).

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Jason Ash named PacificHealth president and CEO

BY Michael Johnsen

MATAWAN, N.J. PacificHealth Laboratories on Thursday named Jason Ash as the company’s president and chief operating officer, as well as a member of the company’s board, effective Jan. 3.

Ash assumes the role of president from Portman, who will continue to serve as chief executive officer, chief scientific officer and chairman.

“Jason brings a great deal of knowledge and experience in the performance beverage arena, and actually led Cadbury’s negotiations leading to their acquisition of the Accelerade and Endurox trade marks and intellectual property,” Portman stated. “Jason’s existing knowledge of our company and our growth objectives will enable him to hit the ground running and provides an excellent opportunity for PacificHealth to rapidly expand upon our existing growth strategy.”

Ash also assumes chief operating officer duties currently held by Stephen Kuchen, who will continue to serve as chief financial officer, treasurer, secretary and director.

Ash brings a decade worth of experience in commercial brand management and consumer marketing to PacificHealth, most recently serving as general manager and vice president of Cadbury Schweppes Americas Beverages Sports in the energy and water category unit.

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Next announces results of Nexrutine dietary supplement study

BY Michael Johnsen

SALINAS, Calif. Next Pharmaceuticals announced Thursday the results of a clinical study on Nexrutine, conducted at The LaValle Metabolic Institute in Cincinnati.

The study concluded that Nexrutine, when used as a dietary supplement, helps in the management of pain and/or inflammation and helps promote a restful sleep with minimal side effects.

“Suffering from pain and inflammation can be a life-changing challenge,” stated Jim LaValle, founder of The LaValle Metabolic Institute and author of many books, including Cracking the Metabolic Code and the Cox-2 Connection. “Many of our patients are relieved to find a natural remedy that is not only cardio protective, but unlike aspirin, is easy on the stomach. This study demonstrates that Nexrutine has an excellent safety profile.”

Out of the 401 participants in the study, 92 percent reported Nexrutine provided pain relief and 93 percent reported improvement in their overall condition.

Nexrutine is a proprietary blend of natural ingredients developed to address general aches and pains associated with physical activity and over-exertion.

The clinical trial was designed to be an open label, single center, clinical trial.

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