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Emergency contraceptive Plan B One Step now on course to be available OTC without any sales restrictions

BY Michael Johnsen

NEW YORK — The emergency contraceptive Plan B (the original two-tablet formulation) can now be sold as an OTC without any sales restrictions as the Obama administration concedes its fight to prevent nonprescription access to younger teenage girls. And soon the newer Plan B One Step (one tablet) will be available without sales restrictions as well.

In a letter to Bonnie Scott Jones, special counsel to the Center for Reproductive Rights, the Food and Drug Administration announced it would comply with a court ruling that the emergency contraceptive Plan B (levonorgestrel) be made available as a nonprescription product without any placement or age restrictions. 

Further, FDA shared that it has invited Teva Pharmaceuticals to submit a supplement to its application for Plan B One Step and has stated it will approve that supplement in short order. "FDA has indicated that the supplement can reference Teva’s supplement submitted for Plan B One Step in February 2011," wrote Janet Woodcock, FDA director, Center for Drug Evaluation and Research. "FDA, in conformance with the court’s order, intends to approve in a timely manner Plan B One Step as a nonprescription product available without point-of-sale or age restrictions." 

After Teva’s supplement is submitted and approved, FDA expects sponsors of the generic versions of Plan B One Step to submit amendments to their abbreviated new drug applications.

However, the government hasn’t necessarily reversed its opposition to OTC availability of levonorgestrel products, noted Washington Post reporter Sarah Kliff in a Wonkblog published Tuesday

Citing an executive-level source within the administration, Kliff suggested the administration realized it would likely lose its appeal on maintaining prescription-only status for the original two-pill formulation of Plan B. "According to the senior official, there was worry about the two-pill product proving too complex for young girls to use it properly," Kliff wrote. "The newer Plan B One-Step, which contains a one-pill dosage of levonorgesterl, is easier to use, which the administration thought made it a safer over-the-counter product."


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Consumer Reports: Robust consumer spending may be on the horizon, just not there yet

BY Michael Johnsen

YONKERS, N.Y. — The Consumer Reports Index, an overall measure of Americans’ personal financial health, shows Americans are reporting significantly fewer financial troubles, Consumer Reports National Research Center announced Tuesday. The Index’s trouble tracker measure fell sharply to 34 from 41.7 a month earlier — the lowest level since the organization first measured it in April 2009.

“The data offer a glimpse that consumers may be starting to see and feel the progress of the economic recovery,” stated Ed Farrell, director of consumer insight at the Consumer Reports National Research Center. "[However,] despite the improvements, consumers are still frigid about robust spending. We are watching closely waiting to see how long it will take them to thaw out from the mindset created by the conditions of the past five years.”     

The level of stress that consumers felt was up slightly to 55.2 from 53.8 last month. The most stressed Americans: women (55.8), those in households earning under $50,000 (57.1), aged 18-34 (56.6), and those in the North East (57.6).

The Consumer Reports trouble tracker has dropped more than 50% from its high-water mark in September 2009, when this measure reached 68.7. The greatest drop in financial difficulties over the past 30 days was among those in households earning less than $50,000, followed by the most affluent in homes earning $100,000 or more. Amidst this general drop in financial difficulties, middle-income Americans experienced a slight rise in financial troubles.

The Consumer Reports index’s employment measure showed that job gains outpaced job losses for the third straight month. The employment measure was little changed this month, rising slightly to 50.6 from 50.3 a month earlier. This uptick was attributable to an increase in the proportion of Americans starting a new job in the past 30 days, and job gains outpaced job losses by a widening margin. The only group that shed more jobs than it gained was among those with a high school education or less.

The Consumer Reports Index’s past 30-day retail measure halted four straight months of decline, ticking upward to 9.2 from 8.7 a month earlier. Among the retail categories the Index tracks, the gain was driven primarily by a large seasonal rise in the major lawn and garden equipment category, and a small uptick in major appliances. The Index also shows that consumers are still not comfortable with robust spending. Planned spending for the next 30 days, reflecting potential June activity, is at 6.0, its lowest level since first measured in April 2009.

The Consumer Reports Index’s trouble tracker measure focuses on both the proportion of consumers that have faced difficulties as well as the number of negative events they have encountered. The negative events include the inability to pay medical bills or afford medication; missed mortgage payment; home foreclosure; interest-rate increase, penalty fees, reduced lines of credit or other changes in credit-card terms; job loss; reduced health-care coverage; and, the denial of personal loans.

The Consumer Reports Index is a monthly telephone and cell phone poll of a nationally representative probability sample of American adults. A total of 1,018 interviews were completed (668 telephone and 350 cell phone) among adults. Interviewing took place between May 30 and June 2.


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Band-Aid, Neosporin celebrate 125 years of the first aid kit

BY Michael Johnsen

SKILLMAN, N.J. — The topical healthcare brands of Johnson & Johnson Consumer Companies, including Band-Aid brand adhesive bandages and Neosporin products, on Tuesday celebrate the 125th anniversary of the first aid kit. In 1888, J&J pioneered the first commercial first aid kits, which were originally designed to help railroad workers care for the wounds and injuries they received from laying railroad track. To commemorate this milestone, the brands have launched a new campaign to help educate consumers about the importance of first aid preparedness.

According to a recent survey with Wakefield Research, as many as 42% of Americans have been unable to care for an injury because they did not have the first aid supplies on hand, J&J noted. Nearly half (46%) of respondents incorrectly believe that an uncovered wound heals faster than a covered wound and nearly a third (31%) of adults do not own a first aid kit. In fact a majority of respondents (62%) say they do not currently have an emergency preparedness plan in place, including an up-to-date first aid kit, emergency meeting place and copies of important documents.

The Everyday Care campaign kicks off with a partnership with Safe Kids Worldwide that leverages the support of Maggie Gyllenhaal on an initiative to prevent childhood injuries by helping educate children and their caretakers about sports safety.

"We are proud to continue our tradition of helping consumers provide comfort and care to their families every day through our partnership with Safe Kids Worldwide," stated Carmen Nestares, marketing director at J&J Consumer Companies. "Now, when consumers create their custom first aid kits, they are not only contributing to a great cause, they are also better preparing themselves and their families with products that fit their specific needs — whether they are getting ready for a summer trip, camp, sporting activities or simply just updating their medicine cabinets."

To help consumers learn more about the importance of first aid and be better prepared for minor injuries, J&J’s Topical Healthcare Brands have created a new microsite that offers important tips as well as coupons for products.

Consumers can support this campaign by creating custom First Aid Kits. When they purchase three or more first aid products they will receive a free first aid bag. For every bag redeemed, the Topical Healthcare Brands will donate to Safe Kids Worldwide.

"With this donation, we will be able to create Sports Safety Clinic Kids’ Zones where children will learn important tips such as how to stay properly hydrated, the importance of warming up, how to handle injuries and how to identify a concussion," commented Kate Carr, president and CEO, Safe Kids Worldwide. 

A complete history of the first aid kit is available on J&J’s Kilmer House blog


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