HEALTH

WSJ: FDA to discuss updating monograph system

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration will host a public meeting in March to discuss updating the OTC monograph system, the Wall Street Journal reported Friday

According to the report, the FDA will consider improving the agency’s ability to initiate label changes quickly, allowing for faster innovation from manufacturers and imposing new pediatric dosing limits based on the most recent science. 

"We want to get the word out that we’re looking for creative ideas about how to improve the process," Janet Woodcock, director of the FDA’s center for drug evaluation, told WSJ.

The meeting will take place March 25 and 26.

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CDC: Working-age Americans hit hard by flu, only 1-in-3 getting flu shot

BY Michael Johnsen

ATLANTA — Only one-third of adults between the ages of 18 and 64 have gotten their flu shot this season, which is a contributing factor to why this year’s flu activity has hit young adults particularly hard, according to Tom Frieden, director of the Centers for Disease Control and Prevention. 

"This year, flu activity has predominantly been H1N1. That’s the same strand of influenza that caused the pandemic in 2009, and it has not mutated substantially," he told reporters during a press conference Thursday. "It’s back this year, and it’s hitting working-age adults hard. One of the reasons it’s hitting younger people hard is that the vaccination rate for young adults 18 to 64 is too low. … And we see this particularly in people who are 18 to 64 who have underlying medical conditions, such as lung disease, asthma, diabetes and obesity." 

By contrast, the vaccination rate for seniors is more than 60% and the vaccination rate for young children is more than 50%.

"We think that children probably were more likely to have both natural immunity and vaccine-induced immunity than the middle-aged adults, and that the seniors both have a high likelihood of being vaccinated but also probably have that long-standing immunity [against H1N1]," commented Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases, explaining why middle-age adults are being hit particularly hard this year by the flu. "[Middle-age adults are] less likely to have natural immunity and less likely to be vaccinated. We believe that’s what is likely going on right now."

A combination of awareness driven by the 2009 H1N1 pandemic along with an increase in convenient access has contributed to driving vaccination rates higher, particularly among children, suggested Schuchat. "We think parents got a wake-up call in 2009, and we’ve seen tremendous progress in pediatric influenza vaccination coverage since the severe disease that was prevalent in 2009 during the pandemic," she said. "Vaccination is now available at workplaces, at pharmacies, shopping centers, as well as of course in the doctor’s office and clinics. And we really are keen … to make it very easy for people to be vaccinated and for them to know how much they can benefit."

And though in some years the vaccination does not match up well with the predominant flu strain, that’s not the case this year. "This season’s vaccines did their job, providing solid protection to people across all age groups," reported Schuchat. "That means if you were vaccinated, you are quite likely to be protected from the flu viruses that have been circulating this season," she said. "This year’s vaccine gave significant protection to all age groups. Vaccine effectiveness point estimates range from 52% for people 65 and older to 67% for children 6 months to 17 years of age."

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Ferndale Healthcare partners with Colon Cancer Alliance

BY Michael Johnsen

FERNDALE, Mich. — Ferndale Healthcare recently announced a three-year partnership on behalf of its RectiCare (lidocaine 5%) Anorectal Cream brand and the Colon Cancer Alliance. This nonprofit corporation is the nation’s leading patient advocacy organization dedicated to increasing colon cancer screening rates and survivorship.

Through this partnership, RectiCare hopes to further the mission of the Colon Cancer Alliance by generating awareness and educating consumers. And over the next three years, RectiCare will be providing financial support to benefit the programs of the Colon Cancer Alliance. Plans to add the Colon Cancer Alliance logo to the RectiCare website Recticare.com, product packaging and collateral materials are currently in the works, Ferndale reported. 

"Consumers experiencing such symptoms as bleeding, soreness and pain are often tempted to self-treat using a variety of over-the-counter preparations. They believe they have hemorrhoids, fissures or other very common anal-rectal maladies,” stated Katherine Gunn, product manager for RectiCare. “We believe it is … our responsibility to encourage consumers to see their physicians to rule out a serious underlying disease, such as colon cancer.”

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