VMS industry requests FDA dedicate greater resources to regulating industry
WASHINGTON – Six associations representing the dietary supplement industry last week requested that the Division of Dietary Supplement Programs be elevated to an “Office” within the Food and Drug Administration.
“We believe that the elevation of DDSP to an 'office' would provide appropriate regulatory attention to the growing industry and increase FDA’s enforcement activities and priorities,” the trade associations said. “In addition, we believe such a reorganization would enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency.”
The trade associations also expressed their concern over “blatant” criminal activity in the supplement industry. “We believe that elevating DDSP’s status to an Office would help increase FDA’s abilities to take more aggressive enforcement action; raise the visibility and attention for dietary supplement safety and compliance measures at FDA; and better utilize CFSAN’s enforcement resources.”
The six associations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.
Over-the-counter home conception kit proven efficacious
PITTSBURGH — A clinical study demonstrates that The Stork OTC is more effective at delivering sperm to the cervix than natural intercourse when trying to get pregnant. The peer-reviewed, post-coital sperm assessment study was performed over a 10-month period by study author Michael Pelekanos, and is published in the Surgical Technology International.
The Stork OTC, the only FDA-cleared, over-the-counter home conception kit using cervical cap insemination, is clinically shown to deliver a higher concentration of sperm directly to the cervix compared to natural intercourse.
The study was an efficacy study designed to compare the number of sperm in the cervical mucus both with the use of The Stork OTC home conception kit and natural intercourse. Post-coital test data was collected after participants used both the Stork OTC home conception kit and the natural intercourse method to evaluate concentrations of sperm in the cervical mucus.
The results are promising for the one-in-six U.S. couples having difficulty conceiving with intercourse alone. “We were very excited to see the study results confirm that The Stork OTC delivers a significantly higher sperm concentration to the cervix,” said Stephen Bollinger, president and CEO of Rinovum Women’s Health. “With the new data demonstrating the efficacy of the Stork OTC in aiding conception compared to natural intercourse, couples trying to get pregnant now have a safe, clinically validated option to optimize their chances with the Stork OTC.”
In 85% of study subjects, the Stork OTC delivered a 3.23x higher value of sperm concentration at the cervix compared to the value of sperm concentration with natural intercourse.
The remaining 15% of study subjects saw no change in sperm concentration between The Stork OTC and natural intercourse.
The kit provides a way for the user to collect, insert and deliver the sperm directly at the opening of the cervix, and keeps it at the cervix for longer, giving sperm the opportunity to enter into the uterus. Considering most sperm never make it through the vaginal tract, the Stork OTC’s applicator provides a simple and safe way for the user to bypass the normally unfavorable vaginal environment, to deliver the sperm. Cervical cap insemination has documented success rates between 10% and 20%, similar to in-clinic intrauterine insemination success rates (16%-21%).
17th Annual DSN Industry Issues Summit again delivers premium insights
NEW YORK — Attendees of the 17th Annual DSN Industry Issues Summit were treated both to critical insights into how to better succeed in the retail pharmacy space and real talk on the challenges and opportunities facing health and wellness merchants. The importance behind creating a personalized patient experience, employing technology to enable more interventions between pharmacist provider and patients and the value within localized product assortments were just a few of the insights trending througout the day.
Attendance at the event — presented by Drug Store News — reached record levels, with 40 retailers and more than 240 supplier participants. Each of the all-star panels featured many of the top minds in pharmacy retailing as they candidly discussed the ins and outs of what's shaping the business and midway through Gary Vaynerchuk, CEO of VaynerMedia, gave a colorful, no-holds-barred assessment of how companies are not optimizing their advertising spends through topically-relevant venues like social media.
The all-day event was held at Manhattan’s historic New York Athletic Club, located directly across the street from Central Park.
“Thank you for making this event one of the most successful ones to date,” Wayne Bennett, group publisher of the Drug Store News Group, told attendees in closing the day's events. “Echoing some of the comments from the panel, why is this event successful? It's successful because most everyone in this room is very passionate about the industry and what they do," he said. "And it's the intellectual capacity [of everyone here] to want to learn more.”
The day started with the Health, Wellness and Technology panel discussion moderated by Chris Dimos of McKesson. Personalization of the consumer experience and investing in streamlining workflow were two hot topics for the morning. Retailer panelists included:
- Josh Flum, CVS Health;
- Tim Weippert, Thrifty White Pharmacy;
- Craig Norman, HEB;
- Rick Gates, Walgreens;
- Brandon Worth, Walmart;
- Frank Maione, Perceptimed;
- Jocelyn Konrad, Rite Aid;
- Philecia Avery, Kroger;
- Kahn Siddiqui, Higi; and
- Jeff Key, Pioneer Rx.
“What are the largest operational challenges that you're trying to solve for today?” asked Dimos.
Retailers are facing an ever-changing regulatory environment, an evolving health consumer dynamic and a heightened expectation of service all under the pressure of tighter margins, one panelist noted. Improving adherence and establishing an appointment-based pharmacy model, vs. transactional, represent opportunities going forward, another panelist noted.
The second panel, this year renamed Chronic Care & Retail Health Retailers in recognition of the fact that retail pharmacy helps manage a number of medical conditions beyond diabetes, was moderated by Dave Wendland of Hamacher Resource Group. Panelists included:
- John DeJames, Giant Eagle;
- Alissa Lynch, Johnson & Johnson;
- Dan Miller, Rite Aid;
- Paul Murphy, Menasha;
- Darren Singer, Shopko;
- Michael Wolf, Walgreens;
- Matt Rutledge, MD Labs;
- Michael Mastromonica, Costco;
- Rachelle Landry, BD Medical;
- Leon Nevers, HEB;
- Tony Willoughby, Health Mart/McKesson; and
- Michael LaMotta, Novo Nordisk.
“What is the magnitude of the task to manage chronic disease states?” asked Wendland.
"It's a daunting task that gets harder every year because of our aging population and diseases that haven't been mitigated," noted one panelist. "The industry needs to figure out a way to connect dots, because that's what our patients need and want. That's what I try to do everyday with great pharmacists, great opticians, great technicians."
And moderator Dan Mack of Elevation Forum wrapped up the panel discussions and capped off the day with the power-packed Industry Issues Summit. During this discussion, retailers discussed what they look for in supplier partners, and the ways in which suppliers can drive mutual value to that partnership. Retailer panelists included:
- Robert Tompkins, Walgreens;
- Maryann Herskowitz, Family Dollar;
- Chris Skyers, Wakefern;
- George Coleman, CVS Health;
- Annie Walker, Walmart;
- Bill Bergin, Rite Aid; and
- Doug Stukenborg, Target.
“The three things that block higher-level growth, is you're not picking the right partners,” said Mack, kicking off the discussion. “[You're] not building a culture that's very distinct [and] you're not hiring people with a growth mindset.”
Mack and his panel addressed several questions on how to maximize growth potential at retail, including balancing boomers with millennial merchandising strategies, optimizing value and premium product solutions and addressing localization challenges.
Sponsors of the event included: AccentHealth, Ateb, BD Medical, Boehringer Ingelheim, Catalina, Emerson Group, GlaxoSmithKline, higi, Hyland's, i-Health, Johnson & Johnson, MD Labs, Menasha, Novo Nordisk, Perceptimed, Pfizer Consumer Healthcare, Pharmavite, Pioneer Rx, Takeda, Unilever, USNutrition and Workplace Impact.
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