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: FDA Inspects Novartis, Pfizer Likes Consumer Fit, CHPA Quantifies OTCs' Value

The Feb. 6 issue of "The Tan Sheet" examines the recent inspection report that suggests FDA influenced Novartis Consumer Health's decisions to cease production at its Nebraska facility in December and recall OTC products in January.

As earnings season continues, we look at Pfizer's plans for its consumer health business -- which increased sales 8% in the fourth quarter -- once it divests the nutritionals and animal health segments.

Elsewhere in this week's edition, we delve into a study sponsored by the Consumer Healthcare Products Association to reveal the full economic value of OTC drugs. Additionally, we've got stories on Johnson & Johnson's latest consumer personnel changes, a follow-up on FDA's pediatric review of Plan B One-Step, and a cover story on the agency's tendency to make broad policy statements via guidance documents -- such as the new dietary ingredient notification draft.

 

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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.

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Deja Vu All Over Again: McNeil Recalls Motrin Product

McNeil Consumer Healthcare’s voluntary recall of 12 million bottles of its Motrin product marks the third consecutive year the Johnson & Johnson business ended the year recalling an OTC drug product.

In a Dec. 21 statement on the Motrin website, McNeil said it is recalling from retailers 59 lots of Motrin IB coated caplets and tablets in 24-count containers and coated caplets in 24+6-count packages -- each product contains 200 mg ibuprofen. The firm said testing of samples showed some caplets may not dissolve as quickly as intended when the products near their expiration date. The lots are being recalled "since there is a chance they could experience a similar problem as they approach expiration,” the J&J business said.

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This Week In OTCs And Nutritionals: A Cold Front Chills Industry

The temperatures outside are dropping, but Jack Frost is not responsible for the cooling relationship between FDA and the dietary supplement industry. Trade groups respond icily to new dietary ingredient notification draft guidance that they say contravenes the Dietary Supplement Health and Education Act. Most groups agree FDA should rewrite the guidance, but “The Tan Sheet” combs through individual comments to highlight the finer points.

HHS Secretary Sebelius also sent a chill through the drug industry when she blocked Teva Pharmaceutical Industry’s attempted full OTC switch of emergency contraceptive Plan B. We look at why Sebelius overrode FDA’s recommendation to make the pill available OTC to all females of childbearing age, and analyze the potential impact the interference could have on future switch attempts and the potential creation of a third drug class.

We also look at FDA’s enforcement priorities for the New Year and its progress on foreign food facility inspections.

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This Week In OTCs And Nutritionals: Trade Groups Rip NDI Guidance, Perrigo’s Prevacid Push-Back, GAO Finds Adulteration Disconnect At FDA

The reviews are in for FDA's new dietary ingredient notification draft guidance, and they aren't pretty. In comments submitted to the agency late last week, the Council for Responsible Nutrition and Consumer Healthcare Products Association call for the controversial guidance to be pulled and rewritten. The Natural Products Association also takes issue with FDA's "overstepping" of the Dietary Supplement Health and Education Act. This week's "Tan Sheet" has the details.

Our Dec. 5 issue also has an exclusive look at Perrigo's citizen petition to FDA that would, in effect, create obstacles for competing generic versions of Novartis' Prevacid 24HR OTC proton pump inhibitor.

Elsewhere in Tan, we describe what went into Embria Health Sciences' successful NDI submission for its EpiCor ingredient, review the Government Accountability Office's recommendations for FDA's economic adulteration initiatives, and catch up with NBTY's efforts to expand in the sports nutrition category.

 

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This Week In OTCs And Nutritionals: Capsugel Moves Past Pfizer, CHPA Talks Self-Selection, GNC Expands Abroad

Our post-Thanksgiving issue of "The Tan Sheet" has a lot more than leftovers. We've got an exclusive interview with Capsugel CEO Guido Driesen, who talks about the oral dosage technology firm's growth plans since being divested by Pfizer.

Inside our Nov. 28 edition, you'll find out what details the Consumer Healthcare Products Association suggests FDA should add to its guidance on self-selection studies for Rx-to-OTC switches. We've also got stories on GNC's expansion into China, Pronova BioPharma's leap from Rx omega-3 drugs to supplements, and what FDA wants industry to do about supplement adulteration.

 

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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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