FDA seizes drugs from Beehive Botanicals
SILVER SPRING, Md. Federal government officials seized “dozens” of products from a company they said had been warned about misstating its medical benefits.
The Food and Drug Administration announced Monday that U.S. Marshals seized products including creams, capsules, tablets, gum, throat spray and shampoos from Haywood, Wis.-based Beehive Botanicals.
According to the FDA, the company misbranded the products by promoting them on its Web site as capable of preventing and curing diseases such as asthma, dermatitis, ulcers, cancer and others. The agency said that the claims meant the products were drugs and were thus subject to FDA regulation, but that Beehive had continued marketing them as medically beneficial despite not subjecting them to clinical trials.
“This seizure shows that the FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness,” FDA acting associate commissioner for regulatory affairs Michael Chappell said in a statement.
The FDA originally warned Beehive in March 2007 not to make drug claims on its Web site and products, and the company originally complied, but during inspections in September and October 2009, the agency said it found the company still was making inaccurate drug claims.
Increased drug sales may yield overall economy’s comeback
WHAT IT MEANS AND WHY IT’S IMPORTANT The uptick in prescription drug sales growth may or may not be yet another indicator of improvement in the U.S. economy, but it is, without a doubt, indicative of a return to growth for the prescription drug market and, by extension, an indicator of growth among retail pharmacies.
(THE NEWS: U.S. drug sales saw growth in 2009, IMS Health says. For the full story, click here)
When IMS Health reported that prescription drug sales had $300.3 billion in sales in 2009, a 5.1% increase over 2008, the figure included every distribution channel. But the bulk of those sales, $164 billion, were through retail channels, including retail pharmacy chains, independents and supermarket pharmacies.
The biggest increase between 2008 and 2009 was in chain stores, which saw a 3.6% increase in prescription drug sales, from $101.8 billion to $105.5 billion. Sales in supermarkets increased by 1.4%, from $20.9 billion to $21.2 billion. Meanwhile, independents had a 2.1% decrease, from $38.1 billion to $37.3 billion. A similar trend appears when figures for dispensed prescriptions are broken down by distribution channel, with a large increase in chain stores, a smaller increase in supermarkets and a decrease in independents.
Sales of specialty drugs went up as well. With $8 billion in sales, compared with $7.5 billion in 2008, monoclonal antibodies for treating cancer rank sixth in IMS’ list of the top 15 therapeutic classes, compared with their seventh-place ranking last year. Biotech drugs for treating arthritis and inflammatory diseases rank eighth and fourteenth, respectively, though erythropoietins, for treating anemia, had a $900 million decrease in sales.
IMS doesn’t have a specific category for the specialty channel, but it does have them for mail service and home health care, two channels used extensively by specialty pharmacies. Though drug sales through the home healthcare channel had a slight decrease, from $2.6 billion in 2008 to $2.5 billion in 2009, mail-service sales increased from $46 billion to $51.5 billion, placing the channel in second place, below retail pharmacy chains, even though it ranked last when measured by U.S. dispensed prescriptions, which also decreased slightly, from 238.4 million in 2008 to 237.5 million in 2009.
Strong efforts by retail pharmacy to boost offerings pay off
WHAT IT MEANS AND WHY IT’S IMPORTANT Serving as yet another indicator of the important role that retail pharmacists play in the U.S. healthcare system is the data conducted by Wolters Kluwer revealing that vaccinations jumped by double-digits this flu season.
(THE NEWS: Flu shot distribution by retail pharmacy increases 36%. For the full story, click here)
As the article states, seasonal flu shots administered by pharmacists grew 36% this flu season, capturing about 10% of the total administered nationwide, according to Wolters Kluwer data.
There are several drivers fueling the growth. First, there’s the fact that retail pharmacy — and the retail health clinics they may have in-store — offers patients a convenient solution for immunizations via an expansive network of immunizing pharmacists, nurse practitioners and physician assistants. And not only do many retail pharmacies set up and promote flu clinics, but several retail-based clinic operators have heavily promoted their services.
As previously reported by Drug Store News, both MinuteClinic, which is owned by CVS Caremark, and Take Care Health Systems, which is owned by rival Walgreens, broke new ground in the second half of 2008 with major ad campaigns promoting their service offerings and convenience.
In September 2008, CVS Caremark kicked off its "Flu Shots Made Simple" campaign to bolster awareness of the company’s integrated flu vaccination offering via MinuteClinic locations, pharmacist-administered shots and scheduled flu shot clinics within select stores.
Take Care Health Systems then announced in mid-October of that year the launch of a new multimedia brand and advertising program dubbed "Life Diagnosis." Similar to MinuteClinic’s campaign, the Take Care campaign had a specific focus on cough-cold-flu and coincided with the official start of cold and flu season, and all Take Care clinics beginning to offer flu vaccines.
Clearly, these efforts have helped shore up foot traffic at community pharmacy and retail-based health clinics.