OverTheCounterToday

FDA Rolls Out Latest AER Label Guidance For OTCs, Supplements

FDA is holding to its existing stance on label requirements for manufacturers of OTC drugs and dietary supplements -- a full domestic mailing address or phone number, along with a clarifying statement, should be printed to facilitate the reporting of serious adverse events.

The OTC drug guidance is available here and the supplement guidance is found here. The documents, officially available Sept. 1, have been revised slightly since the agency last published its current thinking on the topic in December 2008. However, the changes reflect even more information that firms might consider adding to their labels, not verbiage they can omit.

Both guidances now state manufacturers can include an e-mail address or Web site URL on the product labels, in addition to the address or phone number already recommended. FDA also says labels could include a statement advising consumers to call a doctor about any serious AEs.

Plan B Takes One-Step Forward

As Teva's single-pill version of its emergency contraceptive, Plan B One-Step, hits shelves behind pharmacy counters and generics of the original two-dose version become available, Newsweek tries to unravel the rules of when the morning-after pill is available to whom and whether and when consumers need a prescription. This exercise is only slightly less complicated than tracing the regulatory history of the infamously controversial Rx-to-OTC switch.

The launch marks a shift to a more convenient dose, a new period of exclusivity against generics and an expansion of availability. In line with a court ruling earlier this year, the One-Step approval allows OTC sale to 17-year olds, lowering the restriction by a year (See "The Tan Sheet's" July story on the approval here).

One quibble with Newsweek's coverage: The article says, "Complying with the New York court's recommendations has nothing to do with eliminating age restrictions altogether." Not quite true, because the court ordered the agency to reconsider its Plan B decision. The Tan Sheet digs into that issue here.

But as Newsweek correctly states, the product has had a long road to the market. The product's Web site hints at that journey: It states that Plan B One-Step is a trademark of Women's Capital Corp, a subsidiary of Duramed,  a subsidiary of Barr pharmaceuticals, (which of course was bought by Teva in 2008). For more about One-Step, and links to "TheTan Sheet's" vast archive of Plan B stories, start here (Or get a free trial here).

FDA Reviewing Orlistat Safety

FDA's announcement it is investigating a possible risk of liver injury related to orlistat -- the active ingredient in Roche Pharmaceuticals' prescription weight-loss drug Xenical and GlaxoSmithKline's OTC alli –- could threaten future sales.

Despite FDA's encouragement that consumers and patients continue to use orlistat as directed, the announcement of the ongoing safety review could taint public perception of the drug.

The agency said in an Aug. 24 "early communication" letter that it received 32 reports of serious liver injury in patients taking orlistat –- between 1999, when it first approved Xenical (120 mg), and 2008. FDA approved alli (60 mg) in 2007.

Even though FDA emphasizes there is "no definite association between liver injury and orlistat," a spokeswoman said the agency announced the safety review now because "orlistat is a widely used drug, and we wanted to give consumers and health care professionals as much information as possible."

P&G Unloads Rx Business As Tide Turns In Favor Of Consumer Health

Procter & Gamble washes its hands of pharma to focus on growing its portfolio of consumer brands. The company today announced it is selling its Rx assets to Warner Chilcott for $3.1 billion.

In a call to discuss the deal, Chief Financial Officer Jon Moeller highlighted P&G's preference for OTC health products, oral care and beauty over pharmaceuticals, which, despite Actonel sales of more than $1 billion, never truly took off the way the firm had hoped.

"What this really gives us the ability to do is to allocate both financial and human resources to a business that is a better fit with our core competence as a company," he said. "And with that focus, we expect over time higher growth rates from that endeavor."

FDA Gets A Makeover

FDA Commissioner Margaret Hamburg says the realignment of four deputy-level offices in the Office of the Commissioner will streamline "common activities" and strengthen science and food safety.

The agency reorganized the deputy-level offices with oversight of science, administration and policy and elevated the Office of Foods to the same tier, reporting directly to the commissioner's office, according to an Aug. 18 Federal Register notice.

The Office of Foods, headed by a newly created deputy commissioner post, will report directly to the commissioner under the reorganization, whereas before it was part of the Office of Operations, which is renamed the Office of Administration.

FDA's notice also details the duties of the newly established Center for Tobacco Products, mandated by the Family Smoking Prevention and Tobacco Control Act.

Some Resveratrol Marketers Selling A Grape Big Lie

With evidence from animal studies suggesting anti-aging benefits, resveratrol has garnered excitement as a supplement product and for potential Rx applications. Even Oprah sings the praises of the red wine-based substance.

But as the New York Times reports Aug. 17, the market for resveratrol supplements is proving to be full of unsubstantiated claims and unscrupulous salespeople offering a "fountain of youth" in a pill.

The Times points to Hollywood, Fla.-based FWM Labs, which has elicited more than 3,000 consumer complaints to the Better Business Bureau of Southeast Florida thanks to "grossly misleading" advertising and false celebrity "endorsements."

As a result, Bill Sardi of Resveratrol Partners says in the article, his firm's Longevinex supplements cannot keep up with competition that does not play by the rules. "The Tan Sheet" noted the Las Vegas company's recent launch of Longevinex Advantage, combining hyaluronan and antioxidants with the original reseveratrol formulation, in a new product brief here.

FDA Reorganizes, Will Name Tobacco Chief

 

In the same week FDA makes official the reorganization plans Commissioner Margaret Hamburg floated in June, the agency will announce the first director for its tobacco center.

Hamburg also says the agency is conducting a nationwide search for its first deputy commissioner for food, a post assigned to the commissioner's office in the reorganization announced in a notice in the Aug. 18 Federal Register.

The notice makes official the reorganization plans Hamburg identified in a June 29 memo to Department of Health and Human Services Secretary Kathleen Sebelius.

OTC And Nutritionals Business News Roundup, Part 2

In today's roundup...

Matrixx Looks To Transition Customers: The Zicam maker looks to the cold season as the "real test" for its oral delivery products, after incurring heavy costs from the recall of its intranasal remedies.

OTC Cases In The ER: A CDC study points to the prevalence of unintentional pediatric poisonings linked to OTC products in emergency room visits. The industry continues working on dosing devices to prevent overdosing and misuse.

Efficacy Is More Than Skin Deep: A meta-analysis of studies on salicylate-containing topical pain remedies comes up with mixed results. Sports creams show little benefit for sports injuries over placebo, though medicated lotions do appear to have an effect on chronic pain.

OTC And Nutritionals Business News Round Up

A quick wrap-up of stories from "The Tan Sheet" and elsewhere …

Zinc Supplements Ease Diarrhea: Zinc's ability to stop diarrhea offers supplement and ingredient manufacturers a potentially attractive business opportunity as aid organizations and governments begin to distribute the mineral to villages in Bangladesh, India, Mali and Pakistan, according to a TIME article. According to the article, 20 mg of zinc daily for two weeks appears to halt diarrhea, which kills 1.6 million children under 5 years annually. In 2007, Save the Children U.S. spent a whopping $680,000 on zinc supplements for a "handful of villages," in South Mali – a fraction of the potential market. Several African governments are looking at zinc programs, and Ethiopia and Tanzania launched zinc-treatment pilots earlier this year, according to the TIME article. Manufacturers interested in tapping the market, would join about 20 firms that already began making zinc to treat diarrhea in the last few years.

Quesnelle Makes Switch From GSK To Consulting Arena

George Quesnelle, the man behind the Rx-to-OTC switches of smoking cessation products Nicorette and Nicoderm CQ and weight-loss drug alli, left GlaxoSmithKline in May after 30 years in pharmaceuticals. He began as a senior strategic advisor at PinneyAssociates Aug. 1.

In an interview with "The Tan Sheet," Quesnelle reveals that he took on the role of senior VP for global switch and strategic growth at GSK in May 2008 to switch alli in the European Union and then transition into retirement. "The Tan Sheet" reported on GSK's creation of that position and Quesnelle's appointment here and here.