HEALTH

Instead announces new patent grant for its showerhead Amphora applicator

BY Michael Johnsen

LA JOLLA, Calif. Instead, developer of over-the-counter women’s reproductive health products, on Wednesday announced it has been granted a new patent protecting its new reusable “showerhead” vaginal applicator, which it plans to distribute with its FDA-cleared personal vaginal lubricant and candidate microbicide, Amphora, in 2008.

“What sets this applicator apart are its comfort and more effective distribution,” stated Joe Pike, Instead president. “Its unique design not only minimizes potential irritation to vaginal tissue, but it also promotes an even distribution of lubricant internally.”

Designed to be more comfortable and safer for women than currently available options, the new applicator provides better distribution via its rounded “showerhead” tip. It features a standard plunger to distribute up to 4cc of product and a domed tip with multiple pores for better distribution of the gel and easier insertion.

The applicator may have use beyond the Amphora lubricant, Pike added. “We have designed this applicator so it can be used with other products, such as yeast infection creams, spermicides and microbicides,” Pike said.

Instead’s FDA-cleared lubricant, Amphora, is an all-natural, long-lasting formulation that promises to enhance vaginal health and intimacy. It is water-based and safe to use with all condoms.

Instead’s new applicator will be available for purchase at the company’s online store this fall at www.softcup.com, and will retail for approximately $2.95.

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HEALTH

Trio of Democrats sponsors bill giving FDA new authority

BY Michael Johnsen

WASHINGTON If you can’t beat the rules, then change ‘em.

At least that seems to be the thinking behind the introduction of the Non-Prescription Drug Modernization Act on Tuesday, which would give both the Food and Drug Administration and the Secretary of Health and Human Services broad new authorities to quickly amend or appeal OTC drug monographs without being required to pursue notice and comment rulemaking as currently required under the Administrative Procedures Act.

The bill was introduced today by Reps. Henry Waxman, D-Calif., Tom Allen, D-Maine, and Sen. Ted Kennedy, D-Mass. Waxman recently criticized the FDA and industry for not immediately acting upon an FDA advisory committee panel recommendation that cough and cold products should not be marketed for children under the age of six.

Without the cooperation of industry, the FDA would need to pursue a lengthy rulemaking process to make any amendments to the monographs governing kids cough and cold medicines. That process could take years, FDA has reported. This piece of legislation would eliminate that process.

The bill also would add OTC drug advertising to FDA’s purview, moving it from the jurisdiction of the Federal Trade Commission.

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Vicks Comfort CAREvan tours country, gives out hot chocolate and tea

BY Michael Johnsen

CINCINNATI Procter & Gamble on Monday announced that its Vicks Comfort CAREvan will be hitting the road this month and next to help promote Vicks.

Academy Award-winning actress Marcia Gay Harden (Pollock and Mystic River) is teaming up with Vicks on the tour. “My role as wife and mother is my proudest achievement and providing the best care possible to my family is my top priority,” Harden stated. “With the Vicks family of products, I am comforted knowing that I have a range of options to soothe or treat symptoms this cold season.”

At the Vicks Comfort CAREvan, visitors will be treated to complimentary hot chocolate and tea, chair massages, Vicks product samples and be able to take and bring home with them a family portrait for free. Visitors will also be encouraged to video tape a Caring Tribute story, on-site at the Comfort CAREvan, about a person who has cared and comforted them when they needed it most. By sharing their video story, they will have an opportunity to win a $10,000 travel package.

As part of the road tour, P&G will also donate a total of $10,000 to HELP USA, a non-profit organization which helps the homeless and others in need become and remain self-reliant.

The Vicks Comfort CAREvan will be traveling to the following cities:

Nov. 10—New YorkNov. 16-18—CincinnatiNov. 23—IndianapolisDec. 1—AtlantaDec. 7—PhoenixDec. 14-16—DenverDec. 22—Washington

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