OverTheCounterToday

This Week In OTCs And Nutritionals: Pfizer Launches Nutrition Site, Valeant Snaps Up OTCs, FDA Elevates Supplement GMPs

The Jan. 23 issue of "The Tan Sheet" features a look at Pfizer's launch of nutritionpossible.com, a website designed to educate consumers about dietary supplements as well as drive interest in the company's Centrum vitamin brand.

This week's edition also examines how consumer health products play into the amibitious growth goals of Valeant Pharmaceuticals and checks in on CMP Therapeutics, a U.K. start-up preparing to introduce an OTC nasal spray derived from chitin.

Additionally, "The Tan Sheet" has stories on FDA's elevated expectations for supplement good manufacturing practices in 2012, cooperation among supplement trade groups, and more.

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Happy New Year From "The Tan Sheet"!

 

From all of us at "The Tan Sheet," enjoy a happy and healthy new year. We look forward to 2012, our 20th year of publishing(!), as we continue to provide you with the latest and most insightful coverage of the nonprescription pharmaceutical and nutritional industries.

See below for the top stories from the Dec. 19 issue, our final of 2011. For a complete table of contents, and to sign up for a free trial subscription, click here -- no credit card required.

Also, follow the latest OTC drug and nutritional news via "The Tan Sheet" on Twitter and Facebook.

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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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.

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This Week In OTCs And Nutritionals: Class In Session Edition

 
“The Tan Sheet” this week reports on a GlaxoSmithKline-backed study that shows educating consumers about the safety and efficacy of nicotine-replacement therapies could lower their concerns about the products’ prices.

We also report that Pfizer would need to learn a lot about consumers’ safe self selection if the firm wants to switch its high cholesterol treatment Lipitor to OTC, and dietary supplement industry trade groups want to learn more about how FDA will calculate the user fees authorized by the Food Safety Modernization Act.

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Education About NRT Safety Overcomes Smokers’ Cost Barrier – Study
Drug firms could educate consumers about the safety and efficacy of nicotine-replacement therapies to show the products’ value, according to recent research.

Lipitor OTC Switch Would Force Pfizer To Clear Big Research Hurdles
Pfizer would face major hurdles in research on consumers’ safe self-selection for FDA to approve an OTC switch of the firm’s cholesterol treatment Lipitor.

Supplement Industry Questions FDA's Calculations For Food Safety User Fees
Good manufacturing practice compliance becomes more critical for dietary supplement firms as FDA sets the first user fees to cover agency costs for follow-up inspections of facilities and imports and work on mandatory recalls.

This Week In OTCs And Supplements: FDA, Industry Rumble Over NDI Guidance

FDA unloaded its draft guidance on new dietary ingredient notifications over the Indpendence Day break, setting off a war of words with the supplement industry.

"The Tan Sheet" this week offers perspectives on both sides of the issue -- why FDA's top supplement official believes the guidance is reasonable for firms and essential to public health, and why industry stakeholders see potential for an onerous pre-market clearance process.

Elsewhere in the supplement arena, our July 11 issue looks at the agency's inspection priorities and facility targets under its good manufacturing practices program.

Also, we've got analysis of Pfizer's plans to exit the nutritionals business and an exclusive interview with the CEO of Hyland's, who reflects on what Johnson & Johnson's OTC recalls have meant for homeopathic remedies.

[For the best rock 'em, sock 'em coverage of dietary supplements and OTC pharmaceuticals, check out "The Tan Sheet." A free 30-day trial subscription can be yours by clicking here.]
 

TOP STORIES

NDI Guidance Protects Public Health And Allows Innovation – FDA's Fabricant
Present and former top FDA officials with oversight of dietary supplements defend the draft guidance on new dietary ingredient notifications, saying the document serves important public health priorities and will not be onerous to industry.

Pfizer Will Unload Nutrition Division, Keep Consumer Product Unit
Pfizer will divest or spin off its nutrition unit but the firm will keep its consumer product business and look into future OTC switches.

Finished Product Manufacturers Top FDA’s GMP Inspection Targets
Finished product manufacturers are FDA's "first priority" for dietary supplement good manufacturing practice inspections, with contract manufacturers a close second, according to an agency official.

Times Reviews Hatch's Star Turn In Supplement Industry Support

 
The New York Times questions whether Sen. Orrin Hatch’s advocacy has hindered FDA from preventing dangerous products from reaching the market.

This Week In OTCs and Nutritionals: Center Stage Edition

 
In this week's issue of "The Tan Sheet," we lift the curtain on FDA's final rule for testing and labeling sunscreen products and on the agency's proposed rule to cap sun protection values at 50 or 50+ so as not to mislead consumers about the clinical benefit of sunscreens with higher SPF values.

Meanwhile, we shine a spotlight on FDA's warning letters to dietary supplement firms about good manufacturing practices violations. On the international stage, we report on Central and Eastern Europe driving OTC sales growth on the continent and on South Korea liberalizing its OTC access reg.  

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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.