OverTheCounterToday

This Week In OTCs And Nutritionals: Heating Up Edition

 
As Memorial Day marks the unofficial start of summer and the mercury hits nearly 100 in Washington, "The Tan Sheet" is here to keep you up to date on the latest hot news in the OTC and nutritionals industries.

Here in Washington, the American Academy of Pediatricians turns up the heat on its bid to eliminate combination OTC pediatric products, including those containing acetaminophen and Rep. Darrell Issa raises the temperature of his criticism of FDA for its handling of recalls from a McNeil Consumer Healthcare plant in Puerto Rico. Overseas, Johnson & Johnson heats up in Eastern Europe with the purchase of several Russian OTC bands from J.B. Chemicals & Pharmaceuticals.

TOP STORIES 

Pfizer Consumer Chief Sees Chronic Conditions In OTC Future
Future OTC switches of drugs for chronic conditions like high cholesterol could "fundamentally help" alter the health care environment and lower costs, says Pfizer Consumer Healthcare President Paul Sturman.  

AAP Presses FDA To Eliminate OTC Pediatric Combination Products
The American Academy of Pediatrics wants FDA to eliminate OTC combination pediatric cough/cold products.  

J&J Expands Russian OTC Foothold Via J.B. Chemicals Portfolio Acquisition
Johnson & Johnson expands its consumer health presence in Russia and other Eastern European markets with the acquisition of several OTC brands from J.B. Chemicals & Pharmaceuticals.  

(Stay on top of all the hottest OTC and nutritional industry news with "The Tan Sheet." Click here for a free 30-day trial.)

 

J&J Consumer Hopes To Come In From The Cold With Russian Expansion

 
Johnson & Johnson's consumer business augments its presence in Russia and other Eastern European markets with the purchase of J.B. Chemicals & Pharmaceuticals' OTC portfolio.

While the emerging market strategy is hardly novel for a global pharma player, J&J in particular has a lot of ground to make up in its consumer division, where worldwide sales continue to suffer following the Tylenol, et al. recalls of 2010. 

The $260 million deal, announced May 23, gives J&J subsidiary Cilag marketing rights in the former Soviet states to several high-profile products including Doktor Mom herbal cough remedies, Metrogyl antibacterial gel and Rinza cough/cold products. The transaction is expected to close by June or July.

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.)

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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Today's Bill Of Fare: Regulatory Enforcement

 
Over the weekend, the New York Times offered up a menu of stories on health claims for foods. The fare included a main course here about health benefit claims in products across numerous categories of functional foods, and an après-dinner treat here on the use of melatonin in brownies and other desserts, which may run afoul of FDA's regulations on using dietary supplement ingredients in foods.

“The Tan Sheet” also has reported on FDA’s regulation of health benefit claims for food products, here, and on the agency’s enforcement against food products containing ingredients common in supplements but unapproved as food additives, here. 

["The Tan Sheet" serves a weekly feast of nutritional product and OTC drug news and analysis. Click here to sign up for a free 30-day trial.] 

-- Malcolm Spicer (m.spicer@elsevier.com)

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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OTC/Nutritional News Roundup: Sanofi Scopes Out GSK Brands

 
In this week's roundup: Sanofi CEO Viehbacher (pictured above) expresses early interest in GlaxoSmithKline's planned OTC divestments, Indian generics firm Dr. Reddy's pursues nonprescription expansion in Russia, and USANA Health Sciences deals with heavy executive turnover.

 

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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.

FDA Finalizes OTC Liquid Dosing Guidance With Little Change

FDA published May 4 a final guidance document on dosage delivery devices for liquid drug products, a year and a half after putting out a draft. Aside from tweaking its title to make clear the guidance covers orally ingested drugs and not, say, eye drops, the agency has left the document pretty much as is.

Following the draft guidance's release in November 2009, "The Tan Sheet" reported on a number of industry stakeholder comments. For example, the Institute for Safe Medicine Practices called for the sole use of metric units on dosage delivery devices while Sanofi-Aventis sought an exemption from including a dosing device with a drug "if it can be demonstrated that common commercially available devices can be used to provide accurate and consistent dosing."

FDA's nonbinding recommendations largely do not reflect these comments; units of measure still can be teaspoon or tablespoon, as well as metric, as long as they are consistent on both the dosing device and product label.

And in spite of Sanofi's plea for exemption, the agency makes clear it thinks "dosage delivery devices should be included for all orally ingested OTC drug products that are liquid formulations."

This Week In OTCs and Nutritionals: The Old Switcheroo

 

Governments around the world are exploring potential Rx-to-OTC switches as bait to attract consumers to preventive and lower-cost health care options. The latest issue of "The Tan Sheet" looks at the switch potential of drug several categories in the next few years.

We also look at firms that are switching-up their packaging in a bid to boost sales and trim production costs. Some firms consider sustainable packaging initiatives as a way to cash in on the consumers' growing interest in green products, while others consider packaging innovations that cater to the aging population.

["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 free trial issue, click here.]

Global Switches Might Be Easier As Governments Seek To Cut Expenditures – 
Countries struggling to balance budgets might lower regulatory hurdles for Rx-to-OTC switches to cut their health care spending, consultant Nicholas Hall predicts.

OTC, Supplement Firms Wrapped Up In Sustainable Packaging Initiatives –
Makers of OTC drugs and dietary supplements, growing more conscious of the environmental and economic implications of plastic bottles and other containers, are stepping toward more sustainable business practices via packaging innovations.

Key To New Sales From Older Consumers Is Packaging, Delivery Innovation –
Packaging and drug delivery options that cater to the aging population's needs will bring in sales by fostering medication compliance and brand loyalty, industry leaders say.