OverTheCounterToday

OTC, Dietary Supplement And Personal-Care Industry Roundup

 

The food safety reform soap opera continues in Congress, a study on aspirin benefits for breast cancer patients gets a second opinion and we check in on the Personal Care Products Council's annual meeting.

Dingell urges Senate vote on food safety: The Hill reports…

Think before reaching for an aspirin: The National Prescribing Service and the U.S. Preventive Services Task Force suggest...

Love the lipstick: The Personal Care Products Council's 2010 meeting kicks off…

This Week In Cosmetics & Personal Care: Table Of Contents

Parlux Open To Acquisition While Aiming For Profitability In Fiscal 2011
Back in the hands of its founder, Frederick E. Purches, Parlux Fragrances is optimistic that it will return to profitability "in the near future"; meanwhile, the company would not object to being acquired if the right opportunity arose, Purches said.

Revitabrow Launches In Category Grown From Repurposed Eyelash Stimulants
RevitaLash marketer Athena Cosmetics is building upon its success in the eyelash enhancement market with the introduction of Revitabrow, adding to the small but growing category of eyebrow enhancers.

New Phthalates Study Links Kids' Behavior Problems To Moms' Cosmetics Use
A new study exploring a possible link between phthalates exposure in the womb and childhood behavioral problems suggests that regulations need to be in place to limit the chemicals' use in personal-care products, according to investigators.

This Week In OTCs And Supplements: Table Of Contents

The Feb. 22 issue of "The Tan Sheet" profiles how Perrigo is tapping into OTC reimbursement opportunities and offers analysis of how adverse event report data prompted Novartis to take the Maalox brand off a stomachache/diarrhea remedy. We also explain how a recent FTC enforcement action highlights dietary supplement firms' challenge in providing suitable evidence to support product claims.

("The Tan Sheet" is your source for the latest news and in-depth analysis on the OTC and dietary supplement industries. Click here for a complimentary issue.)

Perrigo Pursues OTC Reimbursement Opportunity In Emerging "ORx" Space
The private labeler takes advantage of a trend in which OTC benefits are more readily covered, offering generic OTCs via prescription through pharmacies. The ORx program generated $25 mil. in FY 2009 sales, with around $40 mil. projected this year.

Omega-3 Probe Underscores FTC Standards For Claims Substantiation
FTC warns 11 marketers of children's omega-3 products to substantiate claims or face potential enforcement. The commission will specify how firms should support claims going forward. But stakeholders argue requiring randomized controlled trails to support supplement claims is not always feasible and inappropriately dismisses a significant body of useful science.

Novartis' Maalox Total Relief Rebranding Reflects FDA AER Evolution
FDA's request that Novartis rebrand a Maalox line extension is the latest illustration of the agency taking action based on a relatively small number of serious adverse event reports. The incident underscores the continuing impact on the marketplace of mandatory AE reporting, which is relatively new to many nonprescription products, and could prompt debate on umbrella branding.

OTC Industry Roundup

Walgreens will take Manhattan, more drug companies could take an interest in Japan and Merck says OTC growth takes a global village.

Consolidation in the chain drugstore arena continues with Walgreen Co. acquiring Duane Reade: Walgreens says…

Will wider consumer access to nonprescription drugs spur economic recovery in Japan?: The Wall Street Journal suggests…

Former J&J exec Bridgette Heller will steer Merck's consumer health division toward global expansion: "The Tan Sheet" reports…

Former FDA Commissioner Hayes Dies

Arthur Hull Hayes, Jr., who led FDA from April 1981 through September 1983 and was a nationally known professor of clinical pharmacology, died on Feb. 11, 2010, from complications caused by a chronic illness, according to an obituary published by Munson-Lovetere Funeral Homes of Connecticut. He was 76.

After President Reagan appointed him FDA commissioner, Hayes' service included directing FDA’s response to the Tylenol tampering in 1982. He also called for a voluntary moratorium on direct-to-consumer advertising of prescription medicines and weathered criticism on FDA’s approval of the sweetener aspartame.

According to FDA's Web site, in 1986 Hayes shifted to executive positions in the pharmaceutical industry, served on the editorial boards of Clinical Pharmacology and Therapeutics, Rational Drug Therapy and the Journal of Clinical Pharmacology, and was president of the American Society of Clinical Pharmacology and Therapeutics and the U.S. Pharmacopeia. He retired in 2005, five years after founding MediScience Associates consultants, part of Nelson Communications Inc.

FDA Asks Novartis To Change Maalox Total Relief Name To Prevent Consumer Confusion, Harm

 
FDA asked Novartis to change the name of its OTC Maalox Total Relief product to prevent potentially serious side effects if consumers confuse the product, which has a different indication and active ingredient, with others under the Maalox brand.

FDA  Feb. 17 warned of the potential side effects for some consumers of Maalox Total Relief (bismuth subsalicylate), indicated for relief from stomachache and diarrhea. Other products in the Maalox line  are antacids, including Maalox Advanced Extra Strength.

"Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other," according to Carol Holquist, FDA's director of its Division of Medication Error Prevention and Analysis, in the release.

This Week In Cosmetics & Personal Care: Table Of Contents

 

New Phthalates Study Links Kids' Behavior Problems To Moms' Cosmetics Use
A new study exploring a possible link between phthalates exposure in the womb and childhood behavioral problems suggests that regulations need to be in place to limit the chemicals' use in personal-care products, according to investigators.

Johnson's Shampoo Focus Of Suit Alleging Use Of Banned Substance
Class action lawsuits may proceed against Johnson & Johnson and Wal-Mart for the sale of children's shampoo and baby wash containing methylene chloride, an ingredient banned by FDA.

Church & Dwight Armed For Retail Trade Battle In 2010
Church & Dwight is bracing for a cut-throat retail landscape this year in which it expects competitors to battle for shelf space with aggressive trade promotions and advertising.

This Week In OTCs And Supplements: Table Of Contents

In our Feb. 15 issue, "The Tan Sheet" crosses the pond to explore the ongoing challenges facing the European Union's centralized OTC switch pathway and how the U.K.'s expanded indication for nonprescription nicotine replacement therapies might affect U.S. regulation of those products. We also look at Medco's online drugstore, which makes use of patient data to offer a revolutionary way to buy OTCs. Finally, with earnings season in full swing, we highlight Reckitt Benckiser, Church & Dwight, and other firms as they review fiscal 2009 and plan ahead.

("The Tan Sheet" is your source for the latest news and in-depth analysis on the OTC and dietary supplement industries. Click here for a complimentary issue.)

Medco Backs Online OTC Offerings With Data-Driven Safety Screening
Medco plans to take a big step in monitoring OTC treatments and generating drug use data with an automated drug interaction screening function for its online health product store.

U.K. NRT Harm Reduction Indication Could Be Model For U.S.
The U.K.'s harm reduction indication for a nonprescription nicotine replacement therapy inhaler could bode well for GlaxoSmithKline's request that FDA allow a similar change for NRT products in the U.S.

EU-Wide OTC Approvals Highlight The Drawbacks Of National Processes
National switches comprise the majority of OTC approvals in Europe, and likely will until the European Union opens restrictions on which drugs can use its nascent centralized switch process.

He's No Supplement Maverick

Sen. John McCain may be making news with a recently introduced bill to place greater regulatory pressure on dietary supplements, but S. 3002 is hardly offering anything that the industry hasn't heard proposed before. (Especially if they read "The Tan Sheet.")

We reported on the Arizona Republican's legislation here and explained its proposed regime for dietary ingredients that would subvert the new dietary ingredient notification process established by the Dietary Supplement Health and Education Act.

Another component of the Dietary Supplement Safety Act of 2010 calls for all adverse events linked to supplements, not just serious events, to be reported to FDA. This has been a priority for the U.S. Anti-Doping Agency, whose CEO, Travis Tygart, was on hand when McCain introduced the bill. "The Tan Sheet" looked at USADA's ongoing fight against steroid-containing products sold as supplements in a December story.

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.