HEALTH

CRN responds to Dietary Supplement Safety Act of 2010

BY Michael Johnsen

PHOENIX Former presidential candidate Sen. John McCain, R-Ariz., together with Sen. Byron Dorgan, D-N.D., on Wednesday introduced the Dietary Supplement Safety Act of 2010, a bill that would impose greater restrictions on the entire dietary supplement industry, in part because of the insinuation often made that supplements may contain banned performance-enhancing ingredients.

“Like many of you, I am looking forward to watching the Super Bowl this Sunday and the Winter Olympics later this month,” McCain said. “However, a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy.”

The Council of Responsible Nutrition responded expressed its belief on what the legislation would do to the dietary supplement industry and consumers.

“CRN looks forward to the opportunity to study the legislation and find common ground with the sponsors and supporters of this legislation,” stated Steve Mister, CRN president and CEO. “Where specific provisions are extensions of positions we have already supported and lobbied for, we applaud more voices joining with ours.”

The legislation would require dietary supplement manufactures to register with the Food and Drug Administration and fully disclose all ingredients and provides the agency with mandatory recall authority if a product is found to be unsafe or harmful. However, the act also would require supplement companies to report all adverse event reports, which is more restrictive than the serious adverse event report requirement in place now.

“We do not believe that requiring manufacturers to report all adverse events — not just serious adverse events — would do anything to protect consumers,” countered Mister, because such a requirement would overburden the FDA without affording any greater consumer protection. “FDA itself has stated that this would overburden the Agency and would not help protect consumers,” he noted.

The “dietary supplement” referenced by McCain is the Nikki Haskell’s StarCaps weight-loss supplement, distributed by Balanced Health Products, which was sold in specialty outlets GNC, Vitamin Shoppe and Great Earth Vitamin Stores according to the StarCaps Web site at the time those NFL players were suspended. StarCaps contained bumetanide, a prescription-only diuretic, making it an illegal, adulterated drug. The NFL banned diuretics because they can be used as masking agents for steroids. Balanced Health recalled all StarCaps products in conjunction with the FDA in December 2008.

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HDI signs definitive merger agreement with Nipro

BY Michael Johnsen

FORT LAUDERDALE, Fla. Home Diagnostics announced Wednesday that it signed a definitive merger agreement with Nipro Corp., a global manufacturer and distributor of medical devices, pharmaceutical products and medical and glass products headquartered in Osaka, Japan.

“First and foremost, we are pleased to announce this transaction which provides a substantial current cash premium to our stockholders,” stated Joseph Capper, Home Diagnostics president and CEO. “We believe this transaction is also beneficial to our customers and suppliers because it greatly enhances Home Diagnostics’ capabilities by expanding our product offering and aligning our business with a global healthcare company.”

If the deal goes through, Nipro will acquire all outstanding shares of Home Diagnostics’ common stock for a cash purchase price of $11.50 per share (or an aggregate of approximately $215 million).

However, as part of the agreement Home Diagnostics can still entertain unsolicited acquisition proposals from third-parties before the deal is completed. Nipro will have the right to match any third-party offer, and may be rewarded up to a $6.5 million termination fee if the company declines the offer.

The parties expect the tender offer to commence on or about Feb. 10. The tender offer will remain open for 20 business days from commencement. Subject to the satisfaction of the conditions to the tender offer, the offer is expected to be consummated prior to the end of the first quarter 2010.

With respect to the transactions, Raymond James Financial, Inc. is acting as financial advisor to Home Diagnostics; Satterlee Stephens Burke & Burke LLP is acting as legal advisor to Home Diagnostics; and Greenberg Traurig, LLP is acting as special M&A counsel to Home Diagnostics. Baker & McKenzie LLP is acting as legal advisor to Nipro Corp.

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BD Diagnostics launches ‘Be a Flu Fighter’ initiative

BY Michael Johnsen

SAN DIEGO BD Diagnostics, a segment of Becton, Dickinson and Co., on Wednesday launched its “Be a Flu Fighter” initiative, a program aimed at increasing awareness and preventing influenza.

BD designed the “Be a Flu Fighter” initiative to enhance the ability of healthcare professionals at schools, hospitals, laboratories and other public/private settings to help slow the predicted, rapid spread of influenza by promoting good hygiene, vaccination and other flu prevention strategies. With straightforward, accessible language and graphics, the complimentary, printer-friendly materials can be easily downloaded from www.bd.com/ds/flufighter. The BD site also provides hospitals and laboratories with informational materials designed to help professionals properly obtain and handle specimens for flu diagnosis.

“As a world leader in health care, BD is pleased to provide these much-needed resources. Our role goes beyond providing quality products, and includes enabling healthcare professionals to effectively spread the word about practices that can lead to better prevention, diagnosis and therapy for infectious diseases, such as influenza,” stated Tobi Karchmer, medical director BD Diagnostics.

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