In Brief
This article was originally published in The Tan Sheet
Executive Summary
Pfizer promotes Advil Congestion Relief
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Pfizer promotes Advil Congestion Relief The Advil line extension reaches retail in time for the cold/flu season, and Pfizer promotes the launch with a contest to win a personal shopping assistant for Black Friday – the most "congested" shopping day of the year. The New York pharma said Nov. 16 Advil Congestion Relief combines the pain reliever ibuprofen and antihistamine phenylephrine to relieve swelling, congestion and headache due to nasal inflammation. Pfizer's Wyeth Consumer Healthcare filed the new drug application in July 2009 and FDA cleared it June 2010 ("FDA approves Advil Congestion Relief," "The Tan Sheet" June 7, 2010, In Brief). Groups urge Congress to repeal FSA limits Trade groups ask Congress in a Nov. 18 letter to repeal a provision of the Patient Protection and Affordable Care Act that prevents consumers from paying for OTCs with money from their flexible spending accounts unless they have a prescription. The Consumer Healthcare Products Association, the National Association of Chain Drug Stores and other groups argue forcing consumers to obtain a prescription to use FSA money for OTCs will disrupt efficient patient care and burden the system (Also see "Changes For Spending Account OTC Reimbursement Will Hit Consumers" - Pink Sheet, 13 Sep, 2010.). They argue the Treasury Department's interpretation of the provision that consumers can no longer use FSA debit and credit cards to buy OTCs as of Jan. 15 is "unwarranted." If Congress does not reverse the provision, the groups ask that legislators at least delay implementation. NACDS asked the Internal Revenue Service to delay implementation so retailers could update their dispensing and systems ("NACDS wants clarification on FSA/HSAs," "The Tan Sheet" Oct. 25, 2010, In Brief). Advocates urge increased funding for FDA The Alliance for a Stronger FDA urges congressional leadership in a Nov. 8 letter to "to ensure FDA receives the critical funding it needs." The letter notes the House provided FDA an additional $55 million over the president's request, and urges the Senate to defer to the House in conference. FDA's funding has remained stagnant while its responsibilities have increased, the letter says. Congress passed a continuing resolution to fund the government at fiscal 2010 levels through Dec. 3 ("Congress extends federal funding temporarily," "The Tan Sheet" Oct. 4, 2010, In Brief). FTC approves order against ex-POM exec The Federal Trade Commission approved a final order settling charges against Mark Dreher, who was VP of scientific and regulatory affairs at POM Wonderful. The order, announced Nov. 16, bars Dreher from making disease treatment or prevention claims about POM unless the claim is not misleading and meets FDA requirements. It bars him from making health claims for food, drug or dietary supplements without competent and reliable evidence. The order also applies to endorsements. The order follows an administrative complaint filed Sept. 27 against POM Wonderful and three executives, alleging the company did not have competent and reliable evidence to support claims for its pomegranate drinks and supplements (Also see "POM Wonderful Defends Its Claims, Says FTC Action Is Persecution" - Pink Sheet, 4 Oct, 2010.). Two weeks earlier, POM attacked FTC's revised substantiation standard in a suit (Also see "POM Wonderful Misses Mark In Suit On FTC Claims Standard, Attorneys Say" - Pink Sheet, 20 Sep, 2010.). Refocused Nutrition 21 down in Q1 The ingredient developer says operating income is positive since it sold its branded products group, though without the business, year-over-year revenue fell. "The refocusing of our energies on our core ingredients business is working according to plan," said Nutrition 21 President and CEO Michael Zeher Nov. 12. The Purchase, N.Y., firm reported lower total revenue in its fiscal 2011 first quarter, down 29.8% to $1.6 million. Net loss also climbed 39.7% to $898,000. The firm sold Iceland Health vitamins and its store-brand unit in 2009 ("Nature's Products acquires Nutrition 21 businesses," "The Tan Sheet" Jan. 11, 2010, In Brief). Levine Leichtman buys nutritional firm The Los Angeles-based private equity firm and the management of Santa Cruz Nutritionals acquire the supplement firm from Swander Pace Capital for an undisclosed amount, according to a Nov. 18 release. Santa Cruz Nutritionals recently launched FiberAdvance Gummies with inulin (Also see "New Products In Brief" - Pink Sheet, 26 Apr, 2010.). |