This week, "The Tan Sheet" examines FDA's review of Teva Pharmaceutical Industries' Plan B One-Step levonorgestrel product, and its determination that the emergency contraceptive does not raise pediatric safety concerns. The agency's Pediatric Advisory Committee is meeting this week to discuss Plan B and other drugs.

Our Jan. 30 issue also features coverage of the Food and Drug Law Institute's Food Week, including a discussion of what makes functional food and supplement companies vulnerable to class action lawsuits.

"The Tan Sheet" additionally checks in with supplement industry leaders on what to expect in 2012, and looks back at 2011 via the full-year financial results from Johnson & Johnson, Novartis, Procter & Gamble, and more.

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"The Tan Sheet," Jan. 30, 2012, Vol. 20, No. 5

Top Stories

FDA Analysis Finds Plan B Safe For Children: FDA found only 13 reports of serious pediatric AERs following ingestion of original two-dose Plan B or one-dose Plan B One-Step. In a review released Jan. 27, Office of Surveillance and Epidemiology officials said the data do not causally link the majority of pediatric AERs definitively to the drug.

Tylenol Trickles Back To Shelves As J&J Touts Consumer Turnaround: J&J CEO William Weldon says the firm has “turned the corner on a particularly difficult period” that featured extensive OTC product recalls and QC issues. Worldwide consumer product sales grew slightly in the fourth quarter and full 2011.

Novartis Projects OTC Return By Summer, Expects Flat Sales In 2012: Novartis’ 2012 guidance conservatively assumes the offline OTC facility in Lincoln, Neb., will return to production by mid-year, CEO Joseph Jimenez says. The firm halted shipments of Excedrin and other OTCs from Lincoln in December, and consumer health sales fell 7.3% in the fourth quarter.

Food Safety And Rising Costs Top 2012 Challenges For Supplement Industry: Rising costs could lead to quality control problems in 2012 if consumers will not pay higher prices to cover manufacturers’ higher costs. Continued implementation of food safety reform “is a big deal,” partly because the requirements may be causing higher costs, says Loren Israelsen of the UNPA.

Class Action Claims Often Follow Regulatory Action, Industry Litigation: FDA warning letters, FTC consent orders, Lanham Act litigation and National Advertising Division reviews all provide fodder for attorneys looking to bring consumer product lawsuits. While some case settlements come with large monetary payments, injunctive components also are common and often costly.

Rising Material Costs Burden P&G's Earnings, Spark Price Increases: The marketer of Crest and Prilosec OTC takes a $1.5 billion write-down on its appliances business, and faces continuing pressure from commodity costs. The health care segment’s net sales increased 1% to $3.2 billion, but price increases added 3% to the total, the firm said.

- Dan Schiff (d.schiff@elsevier.com)

Our contribution to today's "Health News Daily" takes a closer look at Johnson & Johnson's full-year financials and what they mean for the recovering consumer health division.

Keep reading for a full reprint of that story, compliments of "The Tan Sheet."

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Tylenol Trickles Back To Shelves As J&J Touts Consumer Turnaround

After two years of struggles, Johnson & Johnson is regaining momentum in its consumer division, which tallied fourth-quarter sales higher than some analysts’ predictions and continues to improve manufacturing.

CEO William Weldon said during the firm’s full-year earnings call Jan. 24 that J&J has “turned the corner on a particularly difficult period” that featured quality control issues and extensive product recalls at the McNeil Consumer Healthcare subsidiary beginning in 2009.

In the fourth quarter, McNeil returned to market some of the recalled Children’s and Infants’ Tylenol products and Tylenol Cold & Flu Severe caplets with plans for continued reintroductions throughout 2012 ("J&J Brand Revival Plan Relies On Marketing, Delivery Innovation" — "The Tan Sheet," Oct. 24, 2011).

Weldon said New Brunswick, N.J.-based J&J is “focused on how we can improve the products we are bringing back.” Such improvements, along with aggressive marketing, likely will be essential in restoring consumer trust in long-absent drug products, many of which now face enhanced competition from other brands and a sizable private label presence.

Under a consent decree with FDA, McNeil’s OTC production facility in Fort Washington, Pa., remains shuttered and plants in Lancaster, Pa., and Las Piedras, Puerto Rico, are operating below maximum capacity due to additional review and approval processes. The firm also continues to seek alternative sites for those facilities’ workloads, executives said.

J&J expects to reopen Fort Washington in 2013 when its remediation concludes.

Consumer Surprises Some Analysts

J&J reported worldwide consumer unit growth of 1.6% to $3.67 billion in the fourth quarter and 2% to $14.88 billion in 2011. The full-year numbers received a boost from international expansion and 2.7 percentage points of currency exchange benefit, as U.S. consumer sales dipped 6.7% to $5.15 billion.

Particularly strong in the consumer segment during 2011 were skin care, up 7.6% worldwide to $3.72 billion and led by Neutrogena; oral care, up 6.4% to $1.62 billion thanks to Listerine line extensions; and baby care, up 5.9% to $2.34 billion.

Women’s health dipped 2.8% over the 12 months to $1.79 billion, reflecting the divestments of e.p.t. home pregnancy tests and Monistat yeast infection treatment in 2011 ("Insight Acquires Monistat In Third Deal With McNeil For Women’s OTC Drugs" — "The Tan Sheet," Sep. 5, 2011).

The OTC/nutritionals business also remained a laggard, with sales down 3.2% to $4.4 billion for the year.

However, OTC/nutritional sales bounced back to 4% global growth in the fourth quarter, to $1.14 billion, as J&J expanded its presence in Russia and Eastern Europe by acquiring Doktor Mom cough remedies and other OTCs from JB Chemicals & Pharmaceuticals Ltd. ("J&J Expands Russian OTC Foothold Via J.B. Chemicals Portfolio Acquisition" — "The Tan Sheet," May 30, 2011).

The October dissolution of J&J’s joint venture with Merck & Co. Inc., which gave J&J full marketing rights to digestive health OTCs Mylanta, Mylicon and Pepcid, also helped counterbalance lost sales from the McNeil recalls, said Louise Mehrotra, J&J’s VP of investor relations ("Merck Looks To “Exploit” Switches With Exit From J&J Joint Venture" — "The Tan Sheet," Oct. 3, 2011).

Reintroducing all recalled OTCs, which includes products under the Benadryl, Motrin and Zyrtec brands, ultimately will return about $650 million in annual sales, Morningstar analysts said.

J&J’s fourth quarter consumer sales edged out some analysts’ estimates, including Deutsche Bank by $15 million and Leerink Swann by $50 million – Leerink analysts’ only underestimation among J&J’s business segments.

Companywide sales reached $16.26 billion in the fourth quarter, a 3.9% gain, and $65 billion for the year, up 5.6%. One-time costs, including those related to device recalls and related litigation, eroded J&J’s net earnings, which dropped 88.8% to $218 million in the fourth quarter and 27.5% to $9.67 billion in 2011.

Weldon Abides

Weldon appears to have outlasted the company’s OTC quality control problems, which ultimately may serve as little more than a footnote to his legacy at the firm’s helm.

In April, Weldon will mark 10 years as chairman and CEO of J&J, where he has worked since 1971. That milestone, coupled with continued turnaround at McNeil, could offer the 63-year-old an opportunity to retire on a high note.

More than a year ago the company elevated Alex Gorsky and Sheri McCoy to be vice chairmen of J&J’s executive committee, a move that suggested one of them will succeed Weldon ("J&J Fills Consumer Chief Post, Promotes Likely CEO Candidates" — "The Tan Sheet," Dec. 20, 2010). McCoy is responsible for the pharmaceutical and consumer businesses and Gorsky oversees medical devices and diagnostics.

Some observers thought the McNeil recalls spelled the end for Weldon’s tenure, especially in late 2010 after a congressional committee grilled him and Colleen Goggins, who subsequently resigned as chairman of the worldwide consumer group. More recently, a federal judge dismissed a securities fraud lawsuit against Weldon, though the suit was allowed to proceed against Goggins and the firm ("In Brief" — "The Tan Sheet," Jan. 2, 2012).

- Dan Schiff (d.schiff@elsevier.com)

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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"The Tan Sheet," Jan. 23, 2012, Vol. 20, No. 4

Top Stories

Pfizer Builds Nutrition Site To Grow Vitamin Business: The website nutritionpossible.com is Pfizer’s latest effort to improve its consumer segment, including the Centrum vitamins line. The site also offers a health assessment tool for recommending supplements and lifestyle changes to consumers.

Valeant Includes OTCs In Bid For Dramatic Growth By 2013: The Ontario-based firm has its sights set on becoming a top-15 pharma company with a $50 billion market capitalization by the end of 2013. Emerging markets and consumer health products, including the recent iNova and Fleming deals, play a big part in Valeant’s plans.

FDA Will Take GMP Inspections To The Next Level: If supplement firms thought FDA inspectors were tough on GMP compliance last year – they ain’t seen nothing yet. FDA investigators are ready to delve into more complex and technical GMP areas after focusing primarily on “surface level areas of GMP compliance” to date, FDA officials warn.

Supplement Trade Groups A “Unified Choir,” Leaders Say: Supplement trade groups discuss the strengths and strategies of multiple voices representing the industry.

CMP Therapeutics Readies EU Launch With An Eye On The U.S.: CMP Therapeutics talks with large and small pharmas about distributing its micronized nasal spray, branded as Atlantic Secret. EU regulatory approval came seven years after the firm’s launch, but CEO Neil Moray Mackenzie expects much less time before a U.S. launch.

- Dan Schiff (d.schiff@elsevier.com)

"The Tan Sheet" this week looks at adverse event reporting data that may point to a kidney stones risk among consumers taking GlaxoSmithKline's weight-loss drug alli (orlistat). Not exactly opportune timing for Glaxo, which is trying to unload the drug, along with other non-core OTCs.

Our Jan. 16 issue also features stories on a wrongful death lawsuit against Johnson & Johnson relating to its recalled OTC products; Novartis' recalls of Bufferin and Excedrin after quality control issues arose at one of its plants; and Perrigo's forthcoming private-label Mucinex launch.

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"The Tan Sheet," Jan. 16, 2012, Vol. 20, No. 3

Top Stories

FDA Evaluates Alli For Potential Serious Risk Of Kidney Stones: FDA adds kidney stones to the list of potential signals of a serious risk for alli based on AER information gathered between July and October 2011. GSK, which is confident in the safety and efficacy of alli when used correctly, placed the only OTC weight-loss drug on the auction block last April, but needs a buyer.

Perrigo Sets Generic Mucinex Launch After Patent Claim Decision: The private labeler clears a Reckitt Benckiser legal hurdle and will launch generic Mucinex (guaifenesin) by April. Watson has filed ANDAs for three Mucinex products and could be a good strategic partner for Perrigo, an analyst suggests.

J&J Wrongful Death Lawsuit Alleges Recalled Tylenol Link: The Tylenol product was from among the recalled lots, but remained available to “preserve the continuation of their billion dollar revenue stream,” the suit alleges. Serious adverse events did not prompt the recalls, which were announced comprehensively, the firm says.

Novartis Opts For OTC Recall, With J&J/McNeil Lessons Still Fresh: After shuttering its Lincoln, Neb., OTC facility, the firm recalls some lots of Bufferin, Excedrin, Gas-X and NoDoz. FDA found a “pattern of problems” when inspecting the plant in 2011, and Novartis’ actions suggest it seeks to avoid the same scrutiny that Johnson & Johnson’s OTC recalls elicited. 

- Dan Schiff (d.schiff@elsevier.com)

At this week's J.P. Morgan Healthcare Conference in San Francisco, pharma industry execs repeatedly emphasized to Wall Street analysts the importance of their consumer product businesses. Highlights follow.

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1. Abbott Chief Financial Officer and Executive VP Thomas Freyman touted the performance of Abbott Nutrition, noting that PediaSure sales grew 20% in 2011 and the unit's ex-U.S. revenue has doubled over the past five years. Between now and 2017, Abbott Nutrition plans nearly 40 product launches across 30 countries, worth about $2 billion in incremental sales, Freyman said. The company also expects the operating margin for nutritionals to increase from the low teens today to more than 20% in that same time period.

With Abbott spinning off its research-based branded pharma business this year, nutritionals are expected to increase in importance for the Abbott Park, Ill., firm, as we reported here.

2. Merck & Co. President and CEO Ken Frazier echoed the common refrain that Merck Consumer Care -- rather than being a candidate for divestment, as analysts have suggested -- creates value because it is "complementary and synergistic with our human health business." The consumer business allows Merck a platform for likely Rx-to-OTC switch candidates including the antihistamine Clarinex, corticosteroid Nasonex and cholesterol drug Zetia, as "The Tan Sheet" reported here. 

Frazier also touted the 3% increase in consumer business sales in the first nine months of 2011 and noted its "attractive operating margins, as well as strong underlying market trends."

3. Perrigo President and CEO Joseph Papa commented on his firm's potential benefit from the latest major branded OTC recall -- this time from Novartis, which recalled certain Bufferin, Excedrin, Gas-X and NoDoz products, as we reported here this week in "Health News Daily." Papa said Novartis' recall and temporary plant shutdown could represent a $70 million to $100 million opportunity for store brands as a full-year event. "There are some opportunities for us to get some incremental commitments from the retailers for additional product," he added.

4. Sanofi CEO Chris Viehbacher played up the benefits of an international OTC business, which the French firm continued adding to in 2011 with the acquisition of an Indian nutraceutical business from Universal Medicare, as we noted here. "When you look at the economic crisis, you want to be careful about how much business you have in government reimbursement, and the consumer isn't affected by this," he said.

Viehbacher also called Sanofi's U.S. launch of the switched OTC antihistamine Allegra last year "a fantastic success."

- Dan Schiff (d.schiff@elsevier.com)

Although actual snow flurries have been scarce in the nation's capitol this winter, 2012 has started with a flurry of activity. First, the U.S. military bans sales of the stimulant DMAA on its bases after two soldiers died and regulators in Canada and New Zealand restrict acess.

Elsewhere in the supplement realm, industry champions Sens. Orrin Hatch and Tom Harkin call on FDA to withdraw the new dietary ingredient draft guidance, citing its conflict with Congress's intent in the Dietary Supplement Health and Education Act.

Finally, FDA posts comments on its self-selection draft guidance, this one from Merck, which mined its studies on the unsuccessful switch of the statin Mevacor to rebut FDA's argument that purchase decisions are "an unreliable surrogate" for self-selection. 

Stay up-to-date on all OTC and nutritional industry news and analysis, from flurries to blizzards, with "The Tan Sheet." For information on a free 30-day trial subscription, click here. No credit card required. Also, follow "The Tan Sheet" on Twitter and Facebook.

Dietary Supplements 

U.S. Military Investigates Supplement Ingredient DMAA, Bans Sales - DoD suspends DMAA sales at military stores after regulators in Canada and New Zealand restricted access and as some U.S. firms change how they market and label the ingredient. These moves and the potential for an FDA review could lead to enforcement against DMAA similar to the 2004 ban against ephedra’s use in supplements. 

Food Groups Petition FDA To Withdraw User Fee Notice - Food industry groups request revocation of the food safety fees notice because FDA determined the amount of fees to be collected “in a manner contrary to the method specified by” FSMA. While other supplement groups also question the fees, CRN “didn’t have any concerns with it.” 

New Products In Brief - Vitamin Shoppe’s True Athlete line enters the sports nutrition ring; Metagenics makes “smart multi”; antacid supplement features ProDigestive enzymes; Wellesse targets bariatric surgery patients; C3* drink tackles stress; more New Products In Brief. 

Regulatory

Nanotech Is “More Than Just Tiny,” Requires FDA Regulation – Lawsuit- Environmental advocacy groups ask FDA to regulate the use of nano-sized particles, particularly in sunscreens and other personal care products, according to a lawsuit seeking an agency response to their 2006 citizen petition that made the same request. 

Park Doctrine Influence Could Wane In Upcoming Cases, Attorney Argues -  As penalties increase under the responsible corporate officer doctrine, attorney Allison Burroughs says to expect increased scrutiny. A DoJ Consumer Protection Branch official says pharma execs will be held responsible because of the role the industry plays in consumers’ daily lives. 

FDA’s Office Of Regulatory Affairs Scrutinizes Recalls Process - ORA sets a 2012 priority of improving the efficiency of the recall process to help reach its overall enforcement and compliance goal of preventing public health emergencies. 

OTCs

N.J. Lawmakers To Consider Age Restriction For DXM - The state legislature’s Law and Public Safety Committee in November unanimously passed the bill to require photo identification for purchases of products containing dextromethorphan and impose a fine of up to $750 on employees and retail establishments for violations. 

People

People In Brief - Bristol-Myers exec to head Teva; GSK’s Witty now Sir Andrew; ISPE names Berg president; more People In Brief. 

News in Brief

In Brief - FDA proposes amending ANDA-blocking petition reg; Sara Lee snaps up Tea Forté; testing by FDA, CDC find no bacteria in Enfamil formula powder; USP offers draft probiotics standards; more news In Brief. 

On The Hill

Hatch, Harkin Call For Withdrawal of NDI Draft Guidance - Sens. Hatch and Harkin ask FDA to craft a new document to replace the current NDI notification draft guidance, recommending the agency “provide needed clarification” on what constitutes an NDI. 

Appropriations Negotiators Allow NIH Translational Science Center Launch- NIH receives more than $500 million to finance the National Center for Advancing Translational Science, created in the consolidated fiscal 2012 appropriations bill. Members of Congress cautioned that NCATS’ work to speed up drug development should not inhibit private efforts in the same arena.

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

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1. Psychiatric researchers at Columbia University say their investigation into omega-3 fish oil and clinical depression has determined that only certain formulations are helpful as a depression treatment adjunct. Dr. Elizabeth Sublette advises dividing the amount of a fish oil capsule's EPA by its combined EPA+DHA amount; a result of 0.60 or greater suggests the product has an optimal ratio. More on Sublette's omega-3 research can be found at http://www.moodstudies.org/ and in the December issue of the Journal of Clinical Psychiatry.  

2. The U.S. Pharmacopeial Convention proposes draft standards for probiotics for inclusion in the Food Chemicals Codex. According to a Jan. 3 announcement, USP includes quality specifications for probiotics strains, such as identification and microbe count, in addition to intended uses in food, in the FCC appendix titled "Microbial Food Cultures Including Probiotics." USP also may begin developing more detailed compendial monograph standards for specific strains, the standards-setting organization says. Health Canada already regulates probiotics products via monograph, as we noted here in October.

3. On Jan. 1, California became the first state to limit sales of dextromethorphan to consumers 18 and older, as the San Francisco Chronicle reports here and "The Tan Sheet" noted in September. The Chronicle says reports of abuse of DXM, found in OTCs such as Mucinex-DM and Robitussin-DM, have increased tenfold in the state since 2003. We reported last month that, according to the National Institute on Drug Abuse's Monitoring the Future survey, cough syrup abuse fell a significant amount among 12th graders but held relatively steady among 8th graders in 2011.

- Dan Schiff (d.schiff@elsevier.com)

The New Year starts with a bang as FDA reveals new enforcement against an ingredient banned from use in supplements and as several companies embrace new brands and strategies in an attempt to start 2012 on the right foot.

Just in time for New Year’s diet resolutions, FDA announces the seizure of products adulterated with ephedrine alkaloids – a move that sends a strong deterrence message. An agency official acknowledges other products likely contain the illegal and undeclared diet aid and that FDA will seek these as part of its enforcement against spiked supplements.

Meanwhile, ProPhase Labs’ CEO Ted Karkus discusses the firm’s plans for 2012 and beyond, including several line extensions for Cold-EEZE and new products that use the state-of-the-art delivery technology available to ProPhase through a joint venture with the Australian delivery technology firm Phosphagenics Ltd. Prestige Brands also hopes to expand its offerings in 2012 by closing the acquisition of 17 brands from GlaxoSmithKline, including BC and Goody’s brands.

Finally, we also take a look back at the most read topics of 2011, including how Johnson & Johnson handled quality control problems, the mystery of Pfizer’s consumer division’s future and the future of Rx-to-OTC switches.

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Rx-to-OTC Switch
Somaxon Could Seek Buyer For Silenor Sleep Aid, OTC Marketing Rights – Somaxon reconsiders its options and might sell the sleep aid Silenor, despite a “clear path” to switch OTC, after the firm’s stock fell from $10.60 per share to 42 cents per share. Procter & Gamble would have first crack at exclusive OTC marketing rights if Somaxon sells Silenor.

Dietary Supplements
Ephedra Back On Regulatory Radar As Supplement Adulterant – FDA acknowledges that enforcement activity on ephedra has been a lower priority than other adulterants since the agency banned ephedrine alkaloids in supplements in 2004. “The presumption was that it was banned and people were abiding by the law,” says FDA supplement official Daniel Fabricant.

Supplement Industry Waits For “Friendlier” MedWatch Form – FDA changes MedWatch form 3500A to accommodate medical device firms’ needs, but will not make changes to facilitate reporting AERs for drug, supplement or food products. The agency and supplement industry stakeholders agree 3500A is not ideal for supplement AERs.

Regulatory
MedWatch Plus Stalled As FDA Prioritizes Food, Animal Drug AER System – FDA is delaying work on the web-based MedWatch Plus system for receiving drug, dietary supplement and medical device adverse event reports to focus on improving a portal for adverse events linked to human and animal food and veterinary drugs. The Food Safety Modernization Act required improvements to the agency’s Safety Reporting Portal, which was implemented in May 2010, according to FDA officials.

Enforcement News In Brief – FDA warns Nenningers Naturals based on Twitter flu prevention claim; Global Sweet Polyols earns warning due in part to dog in facility; Yogi Tea warned for insufficient QC review documentation; more Enforcement In Brief.

OTCs
CEO Karkus Talks Cold-EEZE Turnaround At “Lean, Mean” ProPhase Labs – In an interview, ProPhase Labs CEO Ted Karkus talks about the ongoing turnaround of Cold-EEZE zinc lozenges, ProPhase’s flagship brand, as well as efforts to launch new products and restore relationships with retailers.

Prestige Acquires 17 Glaxo OTC Brands, Enters Analgesics Market – Prestige Brands acquires GlaxoSmithKline’s BC and Goody’s analgesic brands as part of $660 million deal for 17 North American OTC lines, also including Beano gas treatment, FiberChoice supplement and Sominex sleep aid.

Court Rules Studies Don’t Support Cirrhosis – Acetaminophen Link – A few observational case studies are not enough to prove prolonged therapeutic use of Tylenol (acetaminophen) was sufficient to cause a plaintiff’s liver damage, a New York state court ruled in a case brought against McNeil Consumer Healthcare. The appellate division of New York’s Supreme Court ruled the Supreme Court properly determined that the Johnson & Johnson division “met its burden by demonstrating that there was no evidence linking acetaminophen to cirrhosis,” Judge John Leventhal wrote in the unanimous Nov. 22 opinion.

Research & Development
Research & Development In Brief – PPIs linked to community-acquired pneumonia; Vitamin D deficiency linked to heart health; Lacidofil provides multiple benefits; more Research & Development In Brief.

Business & Finance

J&J’s Problems, Pfizer’s Options And Switch Outlook Top “The Tan Sheet” Topics In 2011– Readers of “The Tan Sheet” in 2011 showed the most interest in stories about Johnson & Johnson’s OTC quality issues, Pfizer’s consumer business maneuvers and Rx-to-OTC switch outlooks. Other hot topics included omega-3 drug development, supplement GMP strategies and state pseudoephedrine laws.

In Brief – Shareholder suit against Johnson & Johnson, including CFO Caruso, may proceed; Novartis pauses OTC production at Nebraska plant; Mead Johnson finds Enfamil powder clear of bacteria after stores pull the product; John Gay leaves NPA after two years as executive director and CEO; more news In Brief.

-- Elizabeth Crawford (e.crawford@elsevier.com)

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.

"The Tan Sheet," Dec. 19, 2011, Vol. 19, No. 51

Top Stories 

Updated Plan B Lawsuit Could Expand EC Switch Targets: The Center for Reproductive Rights plans to revise its 2005 complaint against FDA seeking OTC access to emergency contraceptives. In addition to adding HHS Secretary Sebelius as a defendant, CRR likely will ask for OTC sales of second-generation Plan B One-Step since the original product is available only as generics.

Trade Groups Should Encourage Supplement NDI Compliance – Fabricant: NDI compliance is “taking a back seat to how people feel about the guidance,” FDA official Daniel Fabricant says. Industry leaders ask what more they can do to encourage NDI notification compliance, but also reiterate concerns about FDA’s draft guidance.

Glaxo Subsidiary Stiefel’s Former CEO Faces Securities Fraud Charges: The Securities and Exchange Commission alleges Charles Stiefel, former chairman and CEO of family-owned Stiefel Labs, did not disclose to employee-shareholders material information on the value of the firm’s shares as the firm bought back shares before being acquired by GlaxoSmithKline.

Campaign Targets Unsupervised Pediatric Drug Ingestion: The Consumer Healthcare Products Association, the Centers for Disease Control and Prevention and a public-private safe-medication initiative launch the “Up and Away and Out of Sight” campaign to educate caregivers about how to stop curious children from consuming drugs without supervision.

Chart: FDA Warning Letters Finger Inadequate GMP Inspection Responses: Supplement manufacturers can respond to FDA observations detailed in a Form 483 following a good manufacturing practices inspection. However, recent GMP warning letters the agency posted show that many firms miss the opportunity to detail fully their corrective action plans and forestall an official warning from FDA.

- Dan Schiff (d.schiff@elsevier.com)

McNeil Consumer Healthcare’s voluntary recall of 12 million bottles of its Motrin product marks the third consecutive year the Johnson & Johnson business ended the year recalling an OTC drug product.

In a Dec. 21 statement on the Motrin website, McNeil said it is recalling from retailers 59 lots of Motrin IB coated caplets and tablets in 24-count containers and coated caplets in 24+6-count packages -- each product contains 200 mg ibuprofen. The firm said testing of samples showed some caplets may not dissolve as quickly as intended when the products near their expiration date. The lots are being recalled "since there is a chance they could experience a similar problem as they approach expiration,” the J&J business said.

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McNeil said there is no safety concern if the products are used in accordance with the label, but there may be a delay in experiencing relief. Consumers do not need to dispose of or return the products, which  were distributed in the U.S., Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.

McNeil manufactured the Motrin products at its facility in Las Piedras, Puerto Rico, the same plant that was the source of multiple McNeil OTC brands recalled in late 2009 aand 2010 after consumers reported an odor that was linked to packaging contaminated by a chemical residue from wooden pallets another firm supplied.

In late 2010, McNeil recalled 118 lots of Rolaids softchews – about 13 million packages – distributed in the U.S., after receiving consumer complaints about foreign substances in the antacids, including wood and metal fragments. The affected Rolaids were manufactured at a third-party facility, as “The Tan Sheet” reported here.

The Las Piedras plant is one of three manufacturing facilities subject to a consent decree J&J entered in March with FDA and the Department of Justice, requiring independent audits for five years at the plants and authorizing FDA to extend the requirement. The decree followed an investigation prompted by a string of recalls of OTC products in the Tylenol, Motrin, Zyrtec and Benadryl lines in 2009 and 2010, as we reported here.

McNeil's Fort Washington, Pa., manufacturing facility will remain closed until after an independent expert conducts an audit and FDA determines the site is compliant with good manufacturing practices regulations, according to the decree. Along with the Las Piedras, facility, the Lancaster, Pa., plant is allowed to continue operating while being audited.

A McNeil spokeswoman today said the latest recall of the Motrin products will not affect the terms of the decree.

Meanwhile, a federal judge ruled Dec. 21 that a lawsuit claiming J&J misled investors about quality control-failures at those manufacturing plants will proceed, though the judge dismissed claims against CEO William Weldon and McNeil Consumer President Peter Lutherof, Bloomberg reported here

"The Tan Sheet" reported here that, in response to the investors' lawsuit J&J appointed a committee of board members to prepare a report on the OTC quality-control problems. The committee found root causes for the problems, but absolved the firm's executives of any blame.

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