OverTheCounterToday

OTC/Nutritional News From "The Tan Sheet": Advocates Refile Plan B Lawsuit; Plan B Available in University Vending Machine; Korea’s Wider OTC Access Stalls

This Week In OTCs And Nutritionals: Plan B Pediatric Analysis, Class Action Claims, Supplement Industry Year Ahead

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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This Week In OTCs And Nutritionals: Alli Kidney Stones Risk, J&J Wrongful Death Suit, Novartis OTC Recalls

"The Tan Sheet" this week looks at adverse event reporting data that may point to a kidney stones risk among consumers taking GlaxoSmithKline's weight-loss drug alli (orlistat). Not exactly opportune timing for Glaxo, which is trying to unload the drug, along with other non-core OTCs.

Our Jan. 16 issue also features stories on a wrongful death lawsuit against Johnson & Johnson relating to its recalled OTC products; Novartis' recalls of Bufferin and Excedrin after quality control issues arose at one of its plants; and Perrigo's forthcoming private-label Mucinex launch.

This blog is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

This Week In OTCs & Nutritionals: Ring In The New Year ... And The Old

The New Year starts with a bang as FDA reveals new enforcement against an ingredient banned from use in supplements and as several companies embrace new brands and strategies in an attempt to start 2012 on the right foot.

Just in time for New Year’s diet resolutions, FDA announces the seizure of products adulterated with ephedrine alkaloids – a move that sends a strong deterrence message. An agency official acknowledges other products likely contain the illegal and undeclared diet aid and that FDA will seek these as part of its enforcement against spiked supplements.

Meanwhile, ProPhase Labs’ CEO Ted Karkus discusses the firm’s plans for 2012 and beyond, including several line extensions for Cold-EEZE and new products that use the state-of-the-art delivery technology available to ProPhase through a joint venture with the Australian delivery technology firm Phosphagenics Ltd. Prestige Brands also hopes to expand its offerings in 2012 by closing the acquisition of 17 brands from GlaxoSmithKline, including BC and Goody’s brands.

Finally, we also take a look back at the most read topics of 2011, including how Johnson & Johnson handled quality control problems, the mystery of Pfizer’s consumer division’s future and the future of Rx-to-OTC switches.

Ensure you stay ahead in 2012 by making “The Tan Sheet” your go-to weekly source for OTC and nutritional news and analysis. For a free 30-day trial subscription, click here. No credit card required. Also, follow "The Tan Sheet" on Twitter and Facebook.

This Week In OTCs And Nutritionals: Rx-to-OTC Switch Tool, NDI Guidance Opposition, PGT Healthcare Interview

Our Nov. 21 issue takes a look at a risk/benefit assessment tool from the World Self Medication Industry group that could aid the development of Rx-to-OTC switch applications. We've also got an exclusive interview with the leaders of PGT Healthcare -- the new consumer health joint venture between Procter & Gamble and Teva Pharmaceutical Industries.

Additionally, "The Tan Sheet" this week features stories on some vociferous opposition to FDA's new dietary ingredient notification draft guidance and the government's cost estimates associated with compiling an ingredient dossier, as well as the latest on congressional funding for FDA's food safety activities.

 

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This Week In OTCs And Nutritionals: Perrigo Labeling Case, Pfizer Phytosterol Research, GAO Supplement AER Inquiry

Elsevier Business Intelligence launches its revamped website today! Check out the new look of "The Tan Sheet," "The Rose Sheet" and other EBI publications.  

In our Nov. 14 issue, we report on a lawsuit in federal court against Perrigo that raises the question of whether federal regulations pre-empt claims made under state laws on failure to warn. At issue is whether the private labeler should have mentioned the potential for liver toxicity on an ibuprofen product.

Inside "The Tan Sheet," we look at Pfizer's research into the cholesterol-lowering characteristics of nonesterified phytosterols, as used in the firm's Centrum Cardio multivitamin. Pfizer conducted the research to support a comment to FDA arguing that nonesterified phytosterols still should be allowed to make coronary heart disease risk reduction claims, which the agency is planning to phase out.

Additionally, we've got a pair of Capitol Hill supplement stories. Sen. Dick Durbin, D-Ill., requests a Government Accountability Office investigation into FDA's collection and analysis of serious adverse event reports linked to supplements. In the House, Rep. Dan Burton, R-Ind., offers a bill to give the supplement industry an additional 12 years -- up to Jan. 1, 2007 -- of grandfathered status for dietary ingredients on the market.

There's plenty more in this week's "Tan Sheet," including an examination of European obstacles to Rx-to-OTC switch, comments to FDA from Merck and Procter & Gamble on sunscreen regulations, and quarterly sales & earnings coverage.

 

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This Week In OTCs And Nutritionals: FDA Supplement Enforcement, P&G Price Hike, Perrigo Q1

"The Tan Sheet" this week reports on FDA's supplement enforcement priorities with a dispatch from the Council for Responsible Nutrition's recent conference. FDA's Division of Dietary Supplement Programs plans enforcement activity in the areas of new dietary ingredients, good manufacturing practices and adverse event reporting. Also from the CRN conference, a story on what retailers expect to see from supplements and OTCs in the areas of social media marketing and consumer education.

Our Oct. 31 issue keeps pace with the flurry of quarterly earnings reports. In addition to news on Procter & Gamble's planned across-the-board price increase and Perrigo's underperforming OTCs and nutritionals, we've got highlights from Bayer, Colgate-Palmolive, GlaxoSmithKline, Mead Johnson Nutrition and many other reporting companies.

As always, there's plenty more in the latest "Tan Sheet," including a look at how FDA might learn from Health Canada's revised probiotics regulations, scrutiny of Allegra's allergy relief claims, and industry's defense of spray sunscreen safety.    

 

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This Week In OTCs And Nutritionals: Switch, GMPs, Abbott

The Oct. 24 issue of “The Tan Sheet” reports on researchers’ recommendations for sponsors of OTC switch applications based on questions FDA has asked in previous switches, as well as additional news in the OTC sector from firms including Johnson & Johnson and Help Remedies.

We also note that for the first time, FDA submitted GMP warning letters with language explaining the agency considers own-label dietary supplement marketers responsible for their contract manufacturers’ violations. Plus, we look at how Abbott Laboratories’ nutrition business gains importance with the firm’s plan to spin off its research-based branded pharmaceuticals business.

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This Week In OTCs And Nutritionals: Tough-Pill-To-Swallow Edition

As the dietary supplement industry continues digesting FDA’s expectations that significantly more new dietary ingredients notifications are necessary, the agency also dishes out some news on serious adverse event reports that the industry could find hard to swallow, this week’s issue of “The Tan Sheet” reports.

FDA’s Division of Dietary Supplement Programs suggests that supplement firms should be submitting to the agency more of the reports on adverse events the firms are receiving from consumers and other parties. Meanwhile, industry champion Sen. Orrin Hatch makes clear he agrees with stakeholders that FDA’s draft guidance on NDI notifications oversteps regulations established by DSHEA.

In this issue, we also report on an attorney’s caution about functional food advertising claims due partly to increased enforcement in the area.

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Times Reviews Hatch's Star Turn In Supplement Industry Support

 
The New York Times questions whether Sen. Orrin Hatch’s advocacy has hindered FDA from preventing dangerous products from reaching the market.