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: 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: 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.

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FDA Advisory Panel Backs One Concentration For Kids' Solid-Dose Acetaminophen

The votes are in, and a joint advisory panel says FDA should consider requiring that OTC manufacturers produce a single concentration of acetaminophen in solid-dose, single-ingredient pediatric products.

Manufacturers recently said they would voluntarily standardize the concentration for liquid acetaminophen products for kids, but did not support a similar move for solid formulations. Regardless, the Pediatric and Nonprescription Drugs advisory committees voted 17 to 3 on this point.

Also at the joint meeting May 17-18, the advisory panels said industry should expand dosing information for all single-ingredient pediatric acetaminophen OTCs to include children as young as 6 months, and voted unanimously that FDA require weight-based dosing information on acetaminophen drug labels.

The May 19 edition of "Health News Daily" will have more on what went down in Silver Spring, and make sure to catch up with "The Tan Sheet" on May 23 for additional perspective and analysis.

For now, continue reading for the full advisory committee meeting preview story from our May 16 issue.

 

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This Week In OTCs And Nutritionals: Back To The Future Of OTC Drugs

 
This week's issue of "The Tan Sheet" looks at a number of potential turning points and future implications for OTC drugs. Our cover story goes inside Acura Pharmaceuticals' "extraction-resistant" pseudoephedrine, which the firm believes could transform the category of decongestants fueling the methamphetamine controversy in many states.

Our May 16 edition previews the May 17-18 FDA advisory committee meeting, at which the Pediatric and Nonprescription Drugs panels will mull the future of dosing, labeling and packaging for children's acetaminophen products. We'll have more coverage of the meeting this week in "Health News Daily" and in our May 23 issue.

Additionally, "The Tan Sheet" visits with members of the Health Choices Coalition, which seeks to repeal the provision of health care reform limiting coverage of OTC drug purchases under tax-exempt accounts. Future health care costs could grow if consumers have less incentive to buy OTCs, coalition members warn.

Finally, we look at what diagnostic technology and personalized medicine could mean for the future of nonprescription drug development and Rx-to-OTC switches. It will take some ingenuity on the part of industry to make that future a present reality.

 

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This Week In OTCs And Nutritionals: Table Of Contents

 
While "The Tan Sheet" eagerly awaits next week's FDA advisory committee meeting to discuss pediatric dosing of acetaminophen, the OTC industry announced last week it plans to voluntarily move to a standardized concentration of acetaminophen in single-ingredient products for all children up to age 12.

But our May 9 issue has plenty of non-acetaminophen stories, too. We've got exclusive coverage of last week's SupplySide East conference and trade show in Secaucus, N.J., where supplement industry stakeholders examined the food safety law's impact on ingredient suppliers and FDA supplement official Brad Williams said agency inspectors are finding "pretty dismal" compliance with good manufacturing practices.

Additionally, with earnings season in full bloom, "The Tan Sheet" looks at Perrigo's streak of record revenues and profits, and Pfizer's gradually unfolding restructuring plans, which may include consumer business divestments.

 

["The Tan Sheet" will be your source for news and analysis from the May 17-18 FDA advisory committee meeting on acetaminophen, as well as everything else happening in the world of OTC drugs and nutritionals. For information on a risk-free 30-day trial subscription, click here.]

 

TOP STORIES

OTC Industry Standardizes Pediatric Liquid Acetaminophen Concentration
Over-the-counter drug firms will make single-ingredient liquid acetaminophen pediatric products only in one standard concentration to help prevent dosing errors, their trade association said May 4.

Supplement Ingredient Suppliers Should Prepare For Food HACCP Regs
The exemption Congress gave dietary supplement manufacturers from the hazard analysis and critical control points regulations for food products does not extend to ingredient suppliers, experts say.

Perrigo Rogaine Foam ANDA May Help Extend Record Growth
Perrigo's regulatory green light to market the first OTC generic of Men's Rogaine Foam further extends the pipeline that has kept the firm on a streak of record earnings.

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.

FDA Advisory Panel To Evaluate Acetaminophen Pediatric Dosing

 
FDA's pediatric and nonprescription drug advisory committees will consider whether the agency should add new dosing information for children younger than 2 years to labels for OTC products containing acetaminophen at a joint meeting May 17-18.

This Week In OTCs And Supplements: Table Of Contents

 

The OTC, Rx and dietary supplement industries are in a game of musical chairs with several products trading categories.

Where popular OTC pseudoephedrine-containing drugs will land when the music stops, no body knows. But legislators in more states are trying to take away their OTC seat and push them into the prescription-only category. Hawaii, Indiana, Kentucky and Virginia now are considering legislation that would reverse switch the ingredient to prescription-only status. Currently only Mississippi and Oregon require a prescription for PSE products.

Sanofi-Aventis' Allegra scored a seat in the OTC category after FDA approved the firm's Rx-to-OTC switch application. The family of antihistamine drugs will hit OTC retail shelves March 4 and likely will face generic competition soon.

Finally, GlaxoSmithKline switches its position on resveratrol – opting to drop its prescription drug research program for the red wine extract in favor of a new more stable compound with more favorable drug-like properties.

The latest issue of "The Tan Sheet" explores these developments and more, including:

Sanofi Allegra Switch Approval Triggers Race To Market For Perrigo -- Sanofi-Aventis will launch nonprescription Allegra allergy relief products March 4, but the line might not beat private-label fexofenadine products to store shelves.

Rx-Only Pseudoephedrine Legislation Spreads To More States -- Hawaii, Indiana, Kentucky and Virginia join the list of states considering legislation to require a prescription for all drugs containing pseudoephedrine.

FDA's Food Safety Reform Needs More Funding, says Mike Taylor -- FDA will ask Congress to increase funding for implementing food safety reform, with particular interest in expanding the fees imposed on industry, Deputy Commissioner for Foods Mike Taylor says.

[Don't be caught standing when the music stops. "The Tan Sheet" is your source for the most up-to-date news and in-depth analysis of the OTC pharmaceutical and nutritional industries. For more information on a free 30-day trial subscription, click here.]