OverTheCounterToday

This Week In OTCs And Supplements: Table Of Contents

The Feb. 8 issue of "The Tan Sheet" serves up a blizzard of OTC and supplement news, from legislation that proposes a new paradigm for supplement ingredient submissions and adverse event reporting, to the latest state to take aggressive action on OTC drugs used as meth precursors. We also look at what President Obama's budget proposal means for FDA and FTC, as well as insights on FDA's liquid supplement draft guidance and ingredient supplier qualifications.

(There's more where that came from, too. To check out a full issue of "The Tan Sheet," click here.)

McCain Bill Would Upend Supplement NDI Exemptions
Sens. John McCain and Byron Dorgan introduced legislation that would undo grandfather status for dietary ingredients established by DSHEA and upend the new dietary ingredient notification process.

Mississippi PSE Prescription Switch Will Not Start An Avalanche, CHPA Says 
Mississippi lawmakers' decision to make all pseudoephedrine-containing drugs prescription-only will not prompt other states combating methamphetamine to do the same, the Consumer Healthcare Products Association predicts.

FDA Budget Request Shows Optimism For Broad Food Safety User Fees
FDA's fiscal 2011 budget request is the latest nudge to Congress that the agency prefers food safety legislation with both expansive and targeted user fees over targeted fees alone.

Sanofi-Aventis On Track To Double Consumer Health Business

[Editor's note: Keep up with this topic in 'The Tan Sheet,' your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.Or you can request a free sample issue of 'The Tan Sheet' here.]

Sanofi-Aventis' recent consumer health shopping spree places the French firm on track to become one of the world's leading OTC and supplement players in a relatively short time.

In the last two months, Sanofi moved to acquire Chattem, which opens the door to the U.S. consumer health care market, and entered a joint venture focused on vitamins and minerals with China-based Minsheng Pharmaceutical Group, which allows entrance to China's booming VMS business. "The Tan Sheet" detailed these deals here and here.

The deals follow a series of other recent OTC acquisitions by Sanofi in Australia, France, the Netherlands and Argentina.

Altogether these deals put Sanofi well on its way to doubling its consumer health business in the next five years – a goal CEO Chris Viehbacher described in "The Tan Sheet" here. Sanofi reported in November that its OTC business reached $2.2 billion, combined with Chattem's reported $463.3 million in revenue in 2009, Sanofi is more than half way to its goal of roughly $2.8 billion by 2014.

Viehbacher proposed a similar strategy to expand GlaxoSmithKline's consumer business when he was the U.K.-based firm's executive director and president of North American Pharmaceuticals. Read here about this strategy  and how diversifying business could cushion the blow of impending Rx drug patent cliffs that many pharma firms face.

-- Elizabeth Crawford

 

This Week In Cosmetics & Personal Care: Table Of Contents

European Chemicals Agency To Report On REACH Enforcement Project, Part 1
A report summarizing results from the first stage of the REACH enforcement project will be published this spring, according to the European Chemicals Agency.

J&J Extends Leading Skin-Care Brands With Kits Featuring Cytomimic
Capitalizing on momentum in its skin-care business, Johnson & Johnson is introducing new Cytomimic technology to its Aveeno, Neutrogena and RoC brands with dual-product kits for anti-aging needs around the clock.

Fekkai Goes Mass As P&G Meets Consumers "Where They Shop"
Procter & Gamble's decision to take its Frederic Fekkai salon hair-care brand into the mass market exemplifies its approach to meeting consumers where they shop, says CEO Bob McDonald.

This Week In OTCs And Supplements: Table Of Contents

 

Pharma companies continue to expand consumer segments with Sanofi-Aventis entering a vitamin and supplement joint venture in China and Novartis preparing to launch a nonprescription heartburn reliever in 14 European countries. Also, in the latest issue of "The Tan Sheet," we look at the impact of the centralized switch process in Europe on the OTC industry. Back in the States, we explore moves to make pseudoephedrine products Rx-only and a GAO investigation into new dietary ingredients.

[Editor's note: Keep up with this topic in 'The Tan Sheet,' your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.Or you can request a free sample issue of 'The Tan Sheet' here.]

Sanofi Expands Consumer Health Reach With Minsheng VMS Joint Venture – Sanofi-Aventis enters a vitamin and supplement joint venture with China-based Minsheng Pharmaceutical. The deal further expands Sanofi's consumer health care empire and opens the door for Sanofi to distribute products in China

Novartis To Launch Nycomed's PPI Pantoloc Control in 14 European Countries – Under a co-marketing agreement with Nycomed, the Swiss firm looks to launch the proton pump inhibitor in 2010 Q2. The success of the pantoprazole heartburn relief aid hinges on whether Novartis' marketing can set it apart from other PPIs

European Switch Progresses, But Stronger Incentives Needed For OTCs – The OTC industry could "make commercial decisions" reducing its presence in Europe if the nonprescription regulatory climate does not grow more favorable, suggests GSK's Scheske at the Association of the European Self-Medication Industry Jan. 20 meeting in London. Experts discuss drawbacks to centralized switch and goals for smoother regulatory pathway.

Over-The-Counter

• Novartis CEO Jimenez Highlights OTC Switches, Consumer Acquisitions

• C&D's First Response Line Extension Alerts Women One Day Earlier
• P&G Innovation Driving Market Share Gains Of Premium Products

On The Hill

• Wyden's Rx Pseudoephedrine Bill On Doorstep As States Continue Meth Fight

Regulatory

• OTC Dosing Device Guidance Elicits Concern On Spoon Confusion, Added Cost
• GAO New Dietary Ingredient Probe Has Puzzled Firms Seeking Legal Advice

Sales & Earnings

• Matrixx Initiatives Files Suite Against FDA On Unanswered FOIA Grounds
• J&J Expects Sales Loss To Be Skin-Deep, Looks To Skin-Care Lines For Boost
• Colgate's 2010 Product Pipeline Targets Niches In Oral Care, Deodorants
• Sales & Earnings In Brief

In Brief

• Sanofi-Aventis acquires marketing rights to Xyzal
• FDA warns Sunrise on Misbranded OTCs
• FDA says Cerebral Health makes unapproved claims
• NAD says hair supplement claims stretch accuracy
• NAD agrees with Prehistin supplement claims
• Pharmavite names Walsh COO
• Nordic Naturals donates, promotes for Haiti relief
• Science Board discusses CFSAN report
• MHRA switches domperidone maleate

-- Elizabeth Crawford

Novartis To Launch Nycomed's PPI Pantoloc Control In 14 European Countries

[Editor's note: Keep up with this topic in 'The Tan Sheet,' your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.Or you can request a free sample issue of 'The Tan Sheet' here.] 

Novartis will launch the OTC proton pump inhibitor Pantoloc Control (pantoprazole 20 mg) in 14 European countries in the second quarter of 2010 under a co-marketing agreement with the product's originator Nycomed.

The deal, signed in the fourth quarter of 2009 and announced Jan. 26, is "a significant launch for us," a Novartis spokeswoman said in an email.

Novartis considers the European heartburn remedy market largely untapped. While AstraZeneca sells omeprazole OTC as Losec in some countries, the nonprescription stomach remedy market in Europe is less saturated than in the U.S.

"The market in Europe is large," she said. "Reflux symptoms, including heartburn are suffered by up to 45 percent of adults across Europe and frequent heartburn is a major burden for millions of Europeans."

Brian McNamara, European region head for Novartis OTC, said in a release, "Until now the effective treatment choices available over-the-counter were fairly limited."

This Week In Cosmetics & Personal Care: Table Of Contents

 

P&G's eStore To Serve As "Learning Lab" For Studying Consumer Habits Online
Procter & Gamble will launch an e-shopping Web site for its products this spring, with the primary goal of gaining a better understanding of its consumers' online purchasing behavior.

Maker Of Silk'n Hair-Removal Device To Launch Acne, Anti-Aging Systems
Israeli firm Home Skinovations will introduce home-use Silk'n devices for acne treatment and skin rejuvenation in 2010 while it and TRIA Beauty continue to battle for the upper hand in home hair removal.

Beiersdorf Study On Body Odor Spurs Work On Ethnically Sensitive Deodorants
Findings from a recent study on the metabolic causes of body odor could pave the way for the development of deodorants that address the needs of specific ethnic populations, German consumer products firm Beiersdorf reports.

Long Arms Of Laws Touch OTCs, Supplements

Emerging laws of different types and different origins could affect the supply of OTC drugs and nutritional products, "The Tan Sheet" finds this week. While in the U.S. more states are considering Rx-only laws for all pseudoephedrine-containing drugs and in Europe the EU drug regulator recommends pulling an Rx weight-loss ingredient off the market, the law of nature could affect the supply of omega-3 fatty acids.

River of Rx-only PSE bills reaches Mississippi: Local media report…

Alli could benefit from EU pulling Rx weight-loss ingredient: European media state…

Fatty acid sales may trim the fish population: Time magazine says…

This Week In OTCs And Supplements: Table Of Contents

 

Changes are afoot in the dietary supplement arena as FDA's supplement program director Bill Frankos prepares to leave the agency, a firm pleads guilty in a steroid supplement case and ingredient supplier Martek Biosciences moves to expand its supplement portfolio with the proposed acquisition of Amerifit. The Jan. 25 issue of "The Tan Sheet" discusses the ramifications of these changes on the supplement industry. We also explore how the latest twist in the health reform bill debate will impact the pharma industry.

FDA To Fill Frankos' Shoes As Major Dietary Supplement Initiatives Pend – FDA's supplement program director Vasilios "Bill" Frankos exits the agency in March. With NDI guidance pending and GMP inspections continuing, potential successors will face a full plate

Martek Pursues Direct Consumer Access With Pending Acquisition Of Amerifit – Martek bids $200 mil. for the health and wellness company, which offers the ingredient developer a substantially expended portfolio with brands including Culturelle, Estroven and AZO. The deal also marks the omega-3 DHA ingredient supplier's first major foray into consumer marketing. Planned launches include a DHA product aimed at seniors

GSK's Quick Warning On Fake Alli Exemplifies Effective Crisis Management – GlaxoSmithKline and FDA warn consumers Jan. 18 of a "small quantity" of counterfeit alli – just over a month after the firm began receiving consumer complaints. The quick turnaround is "the way crisis management should be done," compared to McNeil's handling of complaints of musty-smelling Tylenol, crisis management expert Bernstein says

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NY Beverage Tax May Use Fluid Definition Of "Dietary Aids"

New York State's proposed tax on soda, energy drinks and sports beverages is riling industry and retailers opposed to what they call a regressive and economically damaging levy. But industry also may have questions about exactly what the dedicated tax means by excluding "dietary aids" and where liquid dietary supplements, medical foods and other nutritional products would fall. 

Gov. David Paterson's 2010-2011 executive budget proposal notes on page 130 that "New York can make great strides in combating the obesity epidemic by applying lessons learned in our battle against tobacco," which the state has heavily taxed. Hence, the proposed tax of about $.01 per ounce of bottled soft drinks and other sugary beverages lacking a certain amount of fruit or vegetable juice.

A coalition of New York retailers oppose the tax and the American Beverage Association rejects the idea of the tax reducing obesity rates. We noted the public health arguments in favor of such a policy here.

FDA Dietary Supplement Leadership Vacancy

 FDA's food center will soon be filling a Bill Frankos-sized hole in its leadership.

The director of FDA's Division of Dietary Supplement Programs at the Center for Food Safety and Applied Nutrition, Vasilios "Bill" Frankos, will retire from the agency in March and move to Herbalife, taking the position of senior VP of product compliance and safety, the firm announces Jan. 19.

Frankos joins the global marketer of weight-loss, nutritional and personal care products effective in April, the firm says.

"Bill Frankos exemplifies Herbalife's commitment to providing science-based nutritional supplements of the highest quality available in the marketplace," says Michael O. Johnson, Herbalife chairman and CEO, in the Los Angeles-based firm's release.

Frankos, whose responsibilities at FDA include directing policy, budget, and administrative activities related to supplement activities, has been overseeing the "full implementation" of the Dietary Supplement Health and Education Act during the good manufacturing practices era, Herbalife notes in its announcement.

It is not yet known who will fill Frankos' shoes at the agency when he departs.

Daniel Fabricant, VP of scientific and regulatory affairs at the Natural Products Association, said Brad Williams, currently Frankos' assistant, is a "possibility" for a replacement.

Fabricant said it was a smart move on Herbalife's part, to have someone on staff with Frankos' expertise. "Under his watch, we had GMPs. We had AERs," he pointed out.

During his time at FDA, Frankos published the final rule for supplement good manufacturing practices and implemented the serious adverse event reporting requirements.

- Katie Stevenson