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CHPA files comments to FDA regarding OTC Drug Review

BY Michael Johnsen

WASHINGTON — The Consumer Healthcare Products Association on Friday filed comments to the Food and Drug Administration in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter Drug Monograph System, also referred to as the OTC Drug Review.

CHPA’s comments underscored its support for the FDA’s re-examination of the system in an effort to complete the OTC Drug Review. CHPA believes this can best be accomplished by utilizing and reforming mechanisms the FDA already has in place.

“The way over-the-counter products are currently regulated has been demonstrably effective for more than 40 years,” said Scott Melville, CHPA president and CEO. “We can improve upon it without undermining a sensible system that has served consumers well.”

In particular, CHPA offered the following suggestions for streamlining the process to promptly resolve the tentative final monographs:

  • Accelerating completion of  the tentative final monographs through clearer communication on what data/information is needed to complete them;
  • Recognizing FDA has ample authority to address emerging safety issues both within and outside of rulemaking, regardless of whether a monograph is final or tentative final;
  • Prioritizing and breaking TFMs into smaller parts to finalize what can be finalized without waiting for the whole; and
  • Accelerating completion of TFMs through a single point leader outside of Office of New Drugs.

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Real Techniques unveils marketing program featuring Pixiwoo YouTube beauty stars

BY Antoinette Alexander

GURNEE, Ill. — Real Techniques, a Paris Presents brand, is calling all beauty lovers to reveal their inner artist through a sponsored marketing program with Allure magazine.  

They can try their hand at recreating a makeup look designed by Pixiwoo YouTube beauty stars Sam and Nic Chapman for a chance to win an in-person makeover by the sisters. The look — a bronze smoky eye — was inspired by the trending colors of the season and created using Real Techniques makeup brushes.  

One participant will win an in-person makeover with the sisters for them and a friend, including a two-night hotel stay. Two runners-up will receive a virtual makeover with the sisters, as well as an assortment of makeup and the full collection of Real Techniques makeup brushes, and 15 will walk away with a prize package of assorted Real Techniques products. Submissions will be accepted through June 30.

Real Techniques makeup brushes are designed with the expertise of the sisters, who together have worked fashion shows, editorials and celebrity shoots as professional makeup artists. Their YouTube how-to beauty channel, Pixiwoo, has 196 million video views and counting.  Each brush features super-soft bristles and an extended aluminum ferrule for light and easy application.  A color-coded system corresponds to the key steps of makeup application so you can create a base (orange), enhanced eyes (purple), and finish (pink) like a pro.

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Study: Flu vaccines prevent hospitalizations in seniors, even when vaccine effectiveness is low

BY Michael Johnsen

ATLANTA — A new study from the Centers for Disease Control and Prevention found that flu vaccines prevent flu-associated hospitalizations in people 65 years and older, even during seasons when vaccine effectiveness is low, the agency stated Friday. The study reinforces CDC’s existing recommendation for annual vaccination of adults 65 years and older who are at high risk for serious flu-related complications and often most-impacted by serious flu disease each year, resulting in hospitalization or death.

The study, published in Clinical Infectious Diseases online on May 6, used statistical modeling to estimate flu-vaccine-prevented hospitalizations in adults aged 65 years and older for estimates of vaccine effectiveness against medically attended influenza illness, ranging from 10% to 70%. Researchers used CDC flu surveillance data collected during the 2011-12 and 2012-13 seasons. The 2011-12 season was considered to be a mild flu season, whereas the 2012-13 season was characterized as moderate to severe. Using data from these two seasons, researchers were able to determine the varying impact that flu vaccination had in terms of hospitalizations prevented. 

Findings showed that during the more severe 2012-13 flu season, a flu vaccine with 10% effectiveness (and 66% coverage) would avert about 13,000 hospitalizations, whereas a vaccine with 40% effectiveness would avert about 60,000 hospitalizations. In contrast, during the more mild 2011-12 season, a flu vaccine with the same two effectiveness estimates would avert about 2,000 and 11,000 hospitalizations, respectively.

CDC estimates for overall vaccine effectiveness against medically attended influenza illness (across all age groups) for 2011-12 are 47% and for 2012-13 are 52%. The estimates for people 65 and older are 43% for 2011-12 and 32% for 2012-13. Vaccine coverage among people 65 years and older during 2011-12 is estimated to be 65% and 66% during 2012-13.

In addition to estimating hospitalizations prevented by vaccination during these two seasons, the study’s authors also analyzed how many people would need to be vaccinated to prevent one hospitalization. For the 2012-13 season, 476 people would need to be vaccinated to prevent one hospitalization, assuming vaccine effectiveness was 40%; whereas, for the 2011-12 season, 2,457 people would need to be vaccinated to prevent one hospitalization.

Therefore, the study showed that flu vaccination provides a greater benefit against hospitalization during moderate to severe seasons compared with milder seasons, and the number of people who need to be vaccinated to prevent hospitalizations is lower during moderate to severe seasons than during milder seasons. The reason for this is that more people are hospitalized during more severe seasons.

Researchers have known for some time that flu vaccine effectiveness generally is lower in the elderly than in younger, healthy adults. However, this research is reassuring that even when flu vaccination is associated with lower vaccine effectiveness, it can still have a measurable and significant impact on preventing hospitalizations in adults 65 years and older, the CDC stated.

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