This week, "The Tan Sheet" examines FDA's review of Teva Pharmaceutical Industries' Plan B One-Step levonorgestrel product, and its determination that the emergency contraceptive does not raise pediatric safety concerns. The agency's Pediatric Advisory Committee is meeting this week to discuss Plan B and other drugs.
Our Jan. 30 issue also features coverage of the Food and Drug Law Institute's Food Week, including a discussion of what makes functional food and supplement companies vulnerable to class action lawsuits.
"The Tan Sheet" additionally checks in with supplement industry leaders on what to expect in 2012, and looks back at 2011 via the full-year financial results from Johnson & Johnson, Novartis, Procter & Gamble, and more.
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FDA Analysis Finds Plan B Safe For Children: FDA found only 13 reports of serious pediatric AERs following ingestion of original two-dose Plan B or one-dose Plan B One-Step. In a review released Jan. 27, Office of Surveillance and Epidemiology officials said the data do not causally link the majority of pediatric AERs definitively to the drug.
Tylenol Trickles Back To Shelves As J&J Touts Consumer Turnaround: J&J CEO William Weldon says the firm has “turned the corner on a particularly difficult period” that featured extensive OTC product recalls and QC issues. Worldwide consumer product sales grew slightly in the fourth quarter and full 2011.
Novartis Projects OTC Return By Summer, Expects Flat Sales In 2012: Novartis’ 2012 guidance conservatively assumes the offline OTC facility in Lincoln, Neb., will return to production by mid-year, CEO Joseph Jimenez says. The firm halted shipments of Excedrin and other OTCs from Lincoln in December, and consumer health sales fell 7.3% in the fourth quarter.
Food Safety And Rising Costs Top 2012 Challenges For Supplement Industry: Rising costs could lead to quality control problems in 2012 if consumers will not pay higher prices to cover manufacturers’ higher costs. Continued implementation of food safety reform “is a big deal,” partly because the requirements may be causing higher costs, says Loren Israelsen of the UNPA.
Class Action Claims Often Follow Regulatory Action, Industry Litigation: FDA warning letters, FTC consent orders, Lanham Act litigation and National Advertising Division reviews all provide fodder for attorneys looking to bring consumer product lawsuits. While some case settlements come with large monetary payments, injunctive components also are common and often costly.
Rising Material Costs Burden P&G's Earnings, Spark Price Increases: The marketer of Crest and Prilosec OTC takes a $1.5 billion write-down on its appliances business, and faces continuing pressure from commodity costs. The health care segment’s net sales increased 1% to $3.2 billion, but price increases added 3% to the total, the firm said.
- Dan Schiff (firstname.lastname@example.org)