FDA approves Genzyme’s Cerdelga
SILVER SPRING, Md. — The Food and Drug Administration has approved Cerdelga (eliglustat) for the treatment of adult patients with the Type 1 form of Gaucher disease
The disorder — which affects about 6,000 people in the United States, according to the agency — occurs in people who don't produce enough glucocerebrosidase enzyme. This deficiency causes fatty materials to collect in the spleen, liver and bone marrow. Major symptoms of the disease include liver and spleen enlargement, anemia, low blood platelet counts and bone problems. Cerdelga works by slowing down the development of fatty materials by inhibiting the metabolic activity that forms them.
“Today’s approval offers another important treatment option for patients with Type 1 Gaucher disease,” said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “In addition, Cerdelga received orphan drug designation from the FDA, reflecting the agency’s focus and commitment to the development of treatments for rare diseases.”
Cerdelga is manufactured by Genzyme.
Appreciating pharmacy’s advancement
One of the greatest frustrations that one can encounter is the sense of not being heard or understood. So, understandably, pharmacy was extremely frustrated in past years.
For a long time, pharmacy was performing a vital role in patient care, but without a corresponding level of appreciation from the government and from the healthcare community.
When I started as president and CEO of the National Association of Chain Drug Stores in 2007, I often heard from NACDS members and allies that the profession and the industry had to stop “talking to itself” and “preaching to the choir,” and had to be more proactive in communicating pharmacy’s value externally.
Studies validated that point. In 2007, NACDS conducted opinion research among policy-makers, opinion leaders and other influential audiences. It showed that respondents really liked their pharmacies, but had not thought much about pharmacies as part of healthcare delivery. Unfortunately, the treatment — or mistreatment — of pharmacy in public policy reflected that sentiment.
A lot has happened since then. Some of it has flowed from external forces, and much of it has flowed from pharmacy’s proactive stance. Here are just a few examples:
- Any discussion of pharmacy advancement starts with pharmacies themselves. NACDS members have transformed their stores into healthcare destinations and expanded the services they offer;
- Pharmacies proved their accessibility, capacity and capability — particularly in the minds of public health officials — when they emerged as strategic vaccination partners in the face of influenza outbreaks, including H1N1;
- The healthcare reform debate created a venue for pharmacy to make its pitch for the value that it provides. In addition, it became clear that the rollout of the Affordable Care Act required assistance from pharmacies, who are considered by patients to be "go-to” information sources;
- NACDS launched and sustained its communications and advocacy theme: “Pharmacies. The face of neighborhood healthcare”;
- The pipeline of research has yielded proof of what pharmacy has been saying for years. Research regarding benefits of medication adherence — and pharmacy’s ability to foster it — is appearing consistently in peer-reviewed journals, and in policy statements of the Centers for Medicare and Medicaid Services and the Congressional Budget Office;
- The mainstream media have increased their reporting of new pharmacy services, particularly in the face of mounting healthcare access challenges; and
- Pharmacies have become more engaged in grassroots advocacy. NACDS members hosted 118 pharmacy tours and other events for members of Congress in 2013, and have already hosted 103 events in 2014.
We’ve come a long way. Legislation was introduced this year in the U.S. House of Representatives to designate pharmacists as healthcare providers under Medicare Part B, to assist underserved communities. The legislation would enable pharmacists to provide vaccinations, diabetes screenings and self-management education, cardiovascular screenings and more to Medicare patients — as allowed by state laws. An online survey in July of likely voters who are informed and engaged when it comes to current events found that 79% of respondents favor the legislation. The survey, conducted by Public Opinion Strategies and commissioned by NACDS, also found bipartisan support with 85% of Democrats and 76% of Republicans backing it. This reflects the bill’s current co-sponsorship, with 50 Democrats and 44 Republicans cosponsoring it in the House.
Looking back over how far we have come, one could argue that it is time for pharmacy to focus on internal communications again. However, instead of “preaching to the choir,” the message would be one of thanks — for the industry’s great work that has elevated pharmacy’s status and appreciation.
Much work lies ahead to achieve pharmacy’s potential. However, doing that work will be much more rewarding than enduring past frustrations. It also will be much more productive for the patients whom this amazing industry serves.
Steve Anderson, IOM, CAE, is president and CEO of the National Association of Chain Drug Stores.
Retailers take advantage of iBeacon
iBeacon technology, the Apple iOS 7 feature that helps mobile devices track their position relative to stationary beacons by using low-frequency Bluetooth transmissions, is getting quite a bit of attention from retailers.
Grabbing their interest is not only that devices can obtain individualized information from beacons, but also that beacons can obtain individualized information from mobile devices.
Placed in stores, iBeacons also can tell retailers quite a bit about who is shopping and what they are looking for. Here are five retail chains who have taken advantage of iBeacon with pilots and rollouts so far in 2014.
In May, Duane Reade placed iBeacon in its Duane Reade mobile app and launched a 10-store pilot in the New York market. The iBeacon technology pilot is part of an in-store mobile coupon initiative at Duane Reade that enables shoppers to digitally clip coupons and redeem them via a bar code on a smartphone.
The inclusion of this technology to the Duane Reade app adds such features as lock screen notifications when initially approaching a select Duane Reade store location, coupon offers based on historical data and product reviews for timely content at the point of decision. Other features include scanner options that allow for instant product scans revealing detailed item information; mobile coupon clipping for immediate redemption at POS, facilitating a seamless value-added experience via Balance Rewards; and instant Instagram 4-by-4-in. prints directly to a Duane Reade location.
Safeway and Giant Eagle
The Safeway and Giant Eagle grocery chains are both rolling out the inMarket Mobile to Mortar iBeacon location-sensing platform at more than 150 grocery stores in Seattle, San Francisco, and Cleveland, with additional retailers and markets launching in the coming months. As inMarket rolls out its iBeacon network, it will provide shoppers with features including custom coupons, loyalty rewards and grocery list reminders. For example, shoppers who opt-in can be reminded of items a spouse just placed on their shared list, earn loyalty rewards or be directed to a custom special offer.
American Eagle Outfitters is launching the ShopKick ShopBeacon iBeacon solution in 100 top-performing American Eagle Outfitters and Aerie stores across the country. ShopBeacon is an Apple iBeacon-based presence signal for retailers that offers customers rewards, in a currency called “kicks,” for a variety of actions they take as they go about shopping.
As shoppers enter an American Eagle Outfitters store, ShopBeacon will welcome and show them location-specific rewards, deals, discounts and product recommendations without them even having to remember to open the app. It also can tie at-home browsing behavior to in-store benefits; if the customer “likes” a specific product online, if they so choose, ShopBeacon can remind them where in the American Eagle Outfitters store that product is sold.
Chico’s FAS is reportedly building a mobile shopping app for the iOS and Android platforms. According to the Wall Street Journal, the app will integrate with iBeacon location sensors on shelves.
This app, in pilot testing as of February 2014, would reportedly use iBeacons to notify customers who have opted in when they are near items that fit their purchase history. Associates would then use iPads to update the customer’s history.