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Plan B heads toward family-planning aisle

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration last month announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (levonorgestrel) for use without a prescription by women 15 years of age and older. That approval moved Plan B One-Step from behind the pharmacy counter into the family planning section of the pharmacy.

It has been a long process to get Plan B One-Step sold beyond the pharmacy counter with only an age restriction on the sale. Sales for Plan B One-Step totaled $95.4 million for the 52 weeks ended April 21, down 13.4% from the year-ago period, according to IRI sales data across total U.S. multi-outlets. That represents an approximate 53% of the dollar share for the category, which was tracking down 16.1% to $179.6 million in that period.

But the controversy associated with ready access to emergency contraception is not over.

The day following Memorial Day weekend, the FDA was scheduled to plead its case to reverse a district court decision that mandated all levonorgestrel products be placed in OTC sets without any age restrictions at all.

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Bayer extends antacid line with fruit chews

BY Michael Johnsen

There can’t be too many tried-and-true, immediate-action calcium carbonate formulations among heartburn remedies, no matter how many proton-pump inhibitors dot that shelf’s landscape. At least that’s what Bayer Consumer is counting on with its line extension of Alka Seltzer Fruit Chews.

And it’s not a bad bet. GlaxoSmithKline’s Tums brand recently won accolades for its latest line extension; Tums Freshers was named 2013 Product of the Year in the OTC Relief category as part of a survey of more than 50,000 people conducted by global research firm TNS. The brand also was voted the most innovative OTC product launch in the past year as part of DSN’s 2012 Innovies awards.

Tums represents the No. 2 brand in the heartburn category, behind Prilosec OTC. Further, Tums continues to grow at a 4.1% clip, even as the category is down 1.6% across total U.S. multi-outlets for the 12 weeks ended April 21, according to IRI. In fact, sales of all PPIs have been trending down for that 12-week period.

Bayer and GSK may have another PPI switch to contend with in the near future. Pfizer has been shepherding Nexium through the Rx-to-OTC switch process since it bought OTC sales rights to the brand in August.

The article above is part of the DSN Category Review Series. For the complete Digestives Sell-Through Report, including extensive charts, data and more analysis, click here.

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Liability of harmful side effects questioned

BY Alaric DeArment

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

The case, Mutual Pharmaceutical v. Bartlett, involves Karen Bartlett, who took Mutual’s sulindac, a generic version of Merck’s Clinoril. After taking the drug, Bartlett developed and suffered near-blindness, esophageal burns and lung damage, as well as the skin disorders Stevens-Johnson syndrome and toxic epidermal necrolysis. A jury awarded Bartlett $21 million for her injuries, and the Supreme Court heard the case in mid-March.

The issue is, while Bartlett suffered the injuries after taking Mutual’s drug, under federal regulations governing generic drugs, a generic drug company typically does not have to conduct clinical trials — only demonstrate that its product is identical to the branded drug. It relies on the safety and efficacy data collected by the developer of the original branded drug.

"The previous court suggested that the manufacturer in this case, Mutual Pharmaceutical, could comply with the law by simply halting production of the Food and Drug Administration-approved drug in question, sulindac," Generic Pharmaceutical Association president and CEO Ralph Neas said. "This pain drug has been available since 1979, has been dispensed more than 300 million times from 2007 to 2012, and has exhibited a typical safety profile. We cannot confer to unqualified juries the power to undermine FDA rulings and potentially deprive millions of patients the medicines they need. Decisions about the safety and efficacy of drugs belong in the capable hands of the FDA."

In PLIVA v. Mensing, a 2011 case cited by Mutual, the Supreme Court determined that because generic drugs and their labeling are required to be identical to their branded counterparts, generic drug companies cannot be responsible for inadequate labeling.

The case closely follows a ruling by the Alabama state Supreme Court in January in a similar case. The Alabama court ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports. According to the New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer’s acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis make generic versions. Weeks had originally filed the suit in federal court, but the court asked the Alabama Supreme Court to determine if Weeks could sue the branded drug makers.

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