OverTheCounterToday

OTC And Nutritional News Roundup

 
Glaxo agrees to $750 mil. settlement: A whistleblower suit alleging microbial contamination in products including nonprescription anti-infective ointment Bactroban (mupirocin) and an H2 blocker available OTC, Tagamet (cimetidine), and other good manufacturing practice violations at GlaxoSmithKline's former Cidra, Puerto Rico, manufacturing plant leads to a $750 million settlement with the Department of Justice, the New York Times reports here. "The Pink Sheet" DAILY reports here the settlement is the fourth largest amount ever paid by a pharmaceutical firm to the U.S. to resolve criminal and civil allegations relating to the manufacturing and sale of adulterated drugs.

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Bayer pays states $3.3 mil. in health claim litigation: Bayer cut claims that links selenium in its One A Day Men's multivitamins to a reduced risk of prostate cancer before a likely FDA action, but still must pay California, Illinois and Oregon $3.3 million to settle a complaint accusing the firm of “deceptively leveraging fear of prostate cancer” to market the product. The Center for Science in the Public Interest, which noted the prostate claims and filed a separate suit against Bayer, comments here on the settlement, and "The Tan Sheet" reports here on Bayer's June 2009 decision to back off the claim as indications grew that FDA was ramping up enforcement against unsubstantiated health claims.

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GSK, McNeil present at NRT workshop: GlaxoSmithKline and McNeil Consumer Healthcare OTC executives are among industry representatives and researchers making presentations at FDA's Oct. 26-27 workshop in Arlington, Va., that will influence whether the agency expands the indication for nicotine-replacement therapy use beyond the current 12 weeks. We reported here in "Health News Daily" that the Center for Drug Evaluation and Research organized the workshop to explore the long-term safety of nicotine based on animal and human studies, addiction to NRTs and evidence NRTs help with abstinence or reduced smoking levels.

(Read "The Tan Sheet" weekly as we turn over every stone for news about the OTC and supplement markets. Our Nov. 1 issue will debut our new bright, clean format. Sign up here for a risk-free, 30-day trial.)

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

This Week in OTCs And Supplements: Table Of Contents

 
 
Mid-term election fever has reached epidemic proportions, and while we here at the Tan Sheet can't be partisan and recommend any particular fever-reducer, we do have the cure for what ails you if you are suffering from a deficiency in top-quality coverage of FDA, the OTC business and the dietary supplement industry. Choose one or more from our line of knowledge-boosting articles...

TOP STORIES

 

Monograph Modernization Initiative Looks To Close OTC Quality Loopholes

A collaboration among industry, FDA and U.S. Pharmacopeia aims to address what FDA sees as a lack of insight into the quality and purity of OTC monograph drugs.

 

Social Media Can Warm Up Consumers, But Firms Should Watch For Flare-ups

Firms using social media to build their brands need to interest consumers with information and avoid a hard-sell or promotional bent, experts advise.

FDA Issues More Warning Letters, Drops Follow-Up Letters In Favor Of Action

FDA will warn firms only once -- if at all -- before taking stronger enforcement actions to stop systematic quality and safety problems, said Howard Sklamberg, director of the Office of Enforcement at the Office of Regulatory Affairs.

OTC And Nutritional News Roundup: In It To Win It Edition

 

Competition in the OTC drug and nutritional product arenas rarely slows, and "The Tan Sheet" knows businesses around the world vigilantly maintain their conditioning to be ready to run, jump or defend as occasion demands. We note some news items this week that point specifically to firms striving ever onward despite hurdles or obstacles in their course.

Closure on Johnson & Johnson’s year of OTC recalls remains elusive: "The Tan Sheet" reports...

Price not a factor as Piramal looks to add OTC businesses: livemint.com says...

Opurity vitamin maker stays "China Free" course without trademark: ProSynthesis Labs says...

Arbitration panel says accidental DHEA use caused sprinter's positive tests: The Washington Post reports...

(Every week, "The Tan Sheet" reaches the finish line first with the latest developments affecting OTC drugs and nutritionals. Get your free trial subscription started by clicking here.)

This Week In OTCs And Supplements: Table Of Contents

 
 

  
"The Tan Sheet" steps up to the plate and anticipates our readers and other OTC drug and nutritional product industry stakeholders around the world are aware a new federal fiscal year started, U.S. voters are electing a new Congress in two weeks and the San Francisco Giants' Tim Lincecum and others are reaching a new level of pitching prowess in the MLB playoffs. For news you'll find only in "The Tan Sheet," our go-to pitches this week are FDA's "swift. aggressive" pharma regulatory plans, the agency's groundbreaking supplement enforcement action and development of a potential first-in-class OTC cough suppressant.

CDER Enforcement Priorities Include Quality Control, Drug "Criminalization"
FDA’s Center for Drug Evaluation and Research will crack down on manufacturers that try to "farm out responsibility" to contractors, firms that fail to meet reporting requirements and the general "criminalization of our drug supply," compliance office director Autor says. Other priorities include spiked supplements and the unapproved drug initiative.

FDA Enters New Enforcement Territory With Warnings Against Failed NDIs
FDA’s warnings about aromatase inhibitors marketed as supplements mark the first actions linked to a substance rejected as an NDI. Marketing of strength-training products containing steroid-like chemicals is proliferating, says FDA health fraud coordinator Coody. CRN exec Shao points out FDA is enforcing a DSHEA provision "they hadn’t been enforcing before."

GSK Consumer Vet Scheske Sees OTC Potential In Biotech PepTcell's Portfolio
The former Glaxo consumer exec now heads Consumer Health for PepTcell and sees the drug developer’s theobromine formulation as a potential first-in-class cough suppressant. Scheske says the drug’s phase III data show efficacy with benign side effects.

(Take a swing at the weekly coverage of the OTC drug and nutritional product playing fields available only in "The Tan Sheet." Click here for a free 30-day trial.) 

This Week In OTCs And Supplements: Table Of Contents

This Week In OTCs And Supplements: Table Of Contents

 

In 1492, Christopher Columbus sailed the Ocean Blue. And in 2010, "The Tan Sheet" reports on shifting current and tidal patterns in OTCs and supplements. Pfizer announced Capsugel may set sail on its own, presenters at the National Advertising Division explored the world of advertising self-regulation, the supplement industry hits rocky waters as FDA inspections churn up problems at nearly one-third of companies inspected for GMP compliance and the aging population of China explores new OTC options.

(Need help in the New World of OTCs and supplements? "The Tan Sheet" is your guide. Click here for a free trial.)

TOP STORIES 

One-Third Of Supplement GMP Inspections Reveal "Serious Problems" - FDA
About one-third of the 90 dietary supplement good manufacturing practices inspections FDA completed in fiscal 2010 by the start of September revealed serious compliance problems, according to Principal Deputy Commissioner Josh Sharfstein

Capsugel Could Land In Private Equity Crosshairs If Pfizer Divests
Capsugel likely will be the first divestiture from Pfizer's Diversified Businesses following the 2009 Wyeth merger and reorganization, and could be a prime target for a private equity acquisition

National Advertising Division Conference In Brief
The National Advertising Division, a self-regulatory agency that reviews advertising claims, administered by the Council of Better Business Bureaus, held its annual conference Oct. 4 and 5 in New York City. The event, "What's New in Comparative Advertising, Claim Support and Self-Regulation," covered claim substantiation for all types of products at all levels of government and within NAD 

REGULATORY
-FDA Strategic Documents Outline Regulatory Science Priorities
-California Safer Consumer Products Reg Could Require Reformulations

OTCS
-Environmental Group Warns Most Sunscreens Lack UVA Protection
-China's Aging Population Spurs OTC Sales, Looks For More Options

NEW PRODUCTS
-New Products In Brief

MARKETING/ADVERTISING
-NAD Says Celsius Beverage Claims Must Reference Exercise
-Stiefel's MaxClarity "More Medicine," Severe Acne Claims Irritate Competitor

IN BRIEF 
-ERSP deflates Leading Edge's enhancement claims
-Advil campaign targets Tylenol
-Class action suit against J&J
-Novedex recalled
-Health Canada clears Vivimind
-FDA, FTC team up on STD warning letter
-FDA seeks input on consumer surveys
-Slimming Beauty warning
-Calif. nixes smoking-cessation bill
-FDA shrinks TEA estimate
-FDA warns OTC firms of GMP violations

-Carolyn B. Phenicie (c.phenicie@elsevier.com)

POM Wonderful Gives Regulators The Back Of Its Hand

 
 
Lynda Resnick doesn't much care for FDA and the Federal Trade Commission. Both agencies this year have initiated actions against her company, POM Wonderful, for pomegranate juice and POMx supplement health claims.

Resnick makes clear in The Wall Street Journal that she has the patience, willingness and resources to fight for claims that pomegranates benefit prostate and cardiovascular health, among others. "The Tan Sheet" reported on the full extent of POM's alleged violations and its lawsuit against FTC here in our Oct. 4 issue.

POM's new advertising campaign, featured on its website, seems unlikely to elicit any additional FDA warnings or FTC complaints. Its TV spots extol the mythical benefits of pomegranate -- acted out by semi-clothed, tastefully lit historical figures -- and claim only that POM products are "backed by modern science."

This Week In OTCs And Supplements: Table Of Contents

Set sail for high seas adventure in this week's issue of "The Tan Sheet." Our Oct. 4 edition introduces Scott Melville, the incoming captain of the Consumer Healthcare Products Association, called upon to navigate the OTC industry through the choppy waters of pediatric cough/cold product safety, supply chain security and possible ingredient scheduling.

On Capitol Hill, the House Oversight and Government Reform Committee finally landed the elusive great white-haired CEO for a hearing last week. "The Tan Sheet" takes a unique angle on what Johnson & Johnson's William Weldon told lawmakers about his firm's OTC recalls, who's accountable and what could have been done differently with regard to the "phantom recall" of Motrin. 
 
Additionally, Tan Sheet reporter Carolyn Phenicie recently anchored down in the Great Salt Lake for a United Natural Products Alliance seminar on dietary supplement advertising. Check out her coverage of what Federal Trade Commission officials said in Utah and what it means for supplement marketers.

 

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