OverTheCounterToday

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: 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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"The Tan Sheet" News Roundup: J&J Tops Forbes Brand Rankings, Studies Question Supplements, Pryor Re-tries Nanotech Bill

This news roundup is brought to you by "The Tan Sheet," your source for the most in-depth news and analysis from the world of OTC drugs and nutritionals. For information on a 30-day free trial subscription, click here.

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This Week In OTCs And Nutritionals: Asthma Drug Switch Possibilities, J&J Consumer Comeback, AHPA's NDI Congress

 

The cover story for our Sept. 19 issue examines the possibility of Rx-to-OTC switches for asthma drugs, including GlaxoSmithKline's Advair and Merck's Singulair, once they lose patent protection.

Looking inside this week's "Tan Sheet", we report on what Johnson & Johnson is telling market analysts about the resurrection of its consumer business following 2010's recalls. There's also in-depth coverage of the American Herbal Products Association's recent NDI Congress in Chicago, at which supplement industry stakeholders emphasized the importance of a unified response to FDA's new dietary ingredient notification draft guidance.

Additionally, we've got stories on U.S. Pharmacopeia's monograph modernization initiative, an FDA guidance document on self-selection studies for OTC drugs, and what Sen. Tom Harkin has planned for securing the pharmaceutical supply chain.

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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.

[“The Tan Sheet” is your weekly full-course meal with ingredients from throughout the OTC drug and nutritional product industries. Sign up here for a free 30-day trial subscription.]

FDA Unleashes New Dietary Ingredient Notification Guidance

Right on schedule, FDA's long-awaited guidance for new dietary ingredient notifications and related issues emerged over the holiday weekend and is posted here.

The bulk of the guidance addresses practicalities of submitting an NDI notification to FDA -- how and when to submit, which data to include and what to expect from the agency's response. FDA also addresses a number of lingering questions, including whether synthetics, nanoscale materials and previously authorized investigational new drugs can be considered NDIs (typical answer: "It depends").

"The Tan Sheet" will have plenty to say about the guidance in the coming days and weeks. In the meantime, check out our recent related coverage here and here.

 

[Want a free 30-day trial subscription to "The Tan Sheet," your source for the best news and analysis from the world of dietary supplements and OTC drugs? Click here.]

 

- Dan Schiff (d.schiff@elsevier.com)

This Week In OTCs And Nutritionals: Beyond A Shadow Of A Doubt Edition

FDA advisory committees May 18 made clear their preferences on each question the agency posed on dosing directions and labeling for pediatric single-ingredient 
acetaminophen products and on whether a single concentration is needed for solid oral dosage forms. 

“The Tan Sheet” this week makes clear the advisory panel members’ concerns about the safety of children’s acetaminophen products. This issue also leaves no question that industry stands behind the products' safety.

Additionally, we report the development of OTC drugs based on probiotics might require a regulatory system more receptive to research on the microorganisms' use as therapeutic ingredients, and on Procter & Gamble and Colgate-Palmolive touting the growing strength of their branded products over generics.

(Eliminate any doubt about being on top of the OTC drug and nutritional product markets by reading “The Tan Sheet” every week. Click here for a free 30-day trial.)

This Week In OTCs And Nutritionals: Table Of Contents

Our March 14 issue highlights an event nearly two years in the making: the next meeting of FDA's Nonprescription Drugs Advisory Committee, scheduled for May 17-18. The joint session with the Pediatric Advisory Committee will discuss the safety of acetaminophen in children younger than 2 years, as well as the significance of weight-based dosing and strategies for reducing liquid OTC dosing errors.

Check "The Tan Sheet" archives for extensive discussion of these topics, and stay tuned for in-depth coverage of the upcoming meeting.

Also in this week's edition, Johnson & Johnson agrees to a consent decree with FDA regarding quality control issues at the firm's McNeil Consumer Healthcare facilities. We additionally look at the growing membership of the congressional Dietary Supplement Caucus and the latest statement on how omega-3s could help pare down global health care costs.

 

["The Tan Sheet" is your source for up-to-date, in-depth news and analysis covering the OTC pharmaceutical and nutritional industries. For more information on a risk-free 30-day trial subscription, click here.]

 

TOP STORIES

FDA Advisory Panel To Evaluate Acetaminophen Pediatric Dosing
FDA's pediatric and nonprescription drugs advisory committees will consider whether the agency should add dosing information for children under 2 years to labels for OTC products containing acetaminophen at a joint meeting May 17-18.

FDA Enforces Consent Decree Over J&J/McNeil's OTC Manufacturing
FDA will wield tight oversight of Johnson & Johnson subsidiary McNeil Consumer Healthcare's OTC manufacturing operations under a consent decree filed after the firm's quality-control changes failed to satisfy the agency.

Dietary Supplement Caucus Goes Bicameral, Adds Hatch, Harkin As Co-Chairs
Sens. Orrin Hatch and Tom Harkin are no strangers to dietary supplement firms as longtime champions for their interests, but for the first time they are members of the industry's congressional caucus.

This Week In OTCs And Supplements: Table Of Contents

  

 

School kicks off today for many kids, but as we report in "The Tan Sheet" class has already been in session for many in the dietary supplement and OTC industries. This week's issue takes a look at why constant education of retailers is essential to keeping them on-message and in compliance with regard to supplement health claims.

In Social Studies class, USANA Health Sciences gets an "A" from analysts on its Chinese expansion project, making inroads into the market through a strategic acquisition. We explore how the nutritional direct-seller expects to benefit from its purchase of Chinese supplement and infant formula firm BabyCare.

In Science class, FDA's Science Board evaluates the agency's nanotechnology efforts and finds room for improvement. FDA's fiscal 2011 budgest request of $7.3 million for nanotech, used in an increasing number of consumer health products, is insufficient, and FDA should take a leadership role in the emerging field, members of the advisory panel said at an Aug. 16 meeting.

And finally, because some students are bound to fall asleep at their desk, Johnson & Johnson/McNeil hopes to eventually add more explicit sleep-aid language to its Tylenol PM labeling. Our Aug. 23 issue explains how the firm is seeking FDA review of clinical data that could spur an OTC monograph amendment, which would then allow McNeil to make label claims comparable to those made for Pfizer's Advil PM. 

 

(Everything you need to know about OTCs and supplements, you'll learn in "The Tan Sheet." Click here to get your first issue free.)

 

TOP STORIES

McNeil Dreams Of Tylenol PM Sleep-Aid Indication
McNeil Consumer Healthcare says recent clinical data support a sleep-aid/pain relief indication for the ingredient combination in Tylenol PM.

USANA Acquires BabyCare For Faster Route To China
Multi-level dietary supplement marketer USANA Health Sciences chooses a faster route over the "arduous" licensing approach to enter China by acquiring nutritional product firm BabyCare Ltd.

Retailer Training Crucial To Keeping Supplement Claims Compliant
Dietary supplement manufacturers bear the burden of ensuring businesses selling their products comply with claims regulations, experts say.

This Week In OTCs And Supplements: Table Of Contents

 
 

This week's issue of "The Tan Sheet" looks at industry and regulators filling in gaps. Novartis fills in the gap left by Johnson & Johnson's recalled Children's Tylenol products by opportunistically introducing a Triaminic line extension. Reckitt Benckiser plans a Children's Mucinex product to fill a gap in the product line as it prepares to face generic competition. And FDA plans to fill in gaps in public information with its proposals to increase agency transparency. 

Conversely, FDA doesn't quite fill in the gaps regarding the supplement industry's concerns about Sec. 912 of FDAAA.

Our Aug. 2 also fills in our readers on the latest sales and earnings news from companies including NBTY, Colgate, Sanofi and Merck.

(If you're finding gaps in your OTC pharma and nutritional news, try the in-depth coverage and analysis offered by "The Tan Sheet." Click here to check out a free issue.)

 

TOP STORIES

Novartis Extends Triaminic Into Brand Name Void Left By J&J Tylenol Recall
Novartis expedites a Triaminic line extension to take advantage of the branded product gap left by the recall of Johnson & Johnson's Children's Tylenol liquid OTCs.

More FDA Transparency May Confuse Consumers, Stifle Competition, Industry Says
Some FDA proposals to increase transparency could threaten fair competition, innovation and firms' reputations unless the agency provides disclaimers and cautions consumers about drawing conclusions from the information.

FDA Clear On Supplement Ingredient Petitions, But Still Fuzzy On Sec. 912
FDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of unsuccessful investigational new drug applications.