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GPhA speaks out on generics labeling, access

BY David Salazar

WASHINGTON  — This week, the Generic Pharmaceutical Association released statements related to the current state of generics, specifically proposed changes to rules regulating labels on generic drugs from the Food and Drug Administration, as well as steps it believe lawmakers should take to ensure affordable medication access for Americans. 
 
When it comes to accessibility, the organization recommended that lawmakers should encourage the FDA to review the approximately 3,800 generic drug applications awaiting action in a timely manner. GPhA also recommended wider use of generics among low-income Medicare beneficiaries, which it estimates could save $17.7 billion over the course of 10 years.
 
The organization also recommended passing the FAST Generics Act, which it says will keep drug companies from using Risk Evaluation and Mitigation Strategies to keep generics from hitting the market, and called for a repeal of a Medicaid rebate increase for generic drugs included in this year’s budget agreement. 
 
The organization’s president and CEO, Chip Davis, discussed regulations concerning labeling of generics, as the organization says currently, branded and generic drugs have the same label, but a proposed change to generic labeling requirements would require manufacturers to update labels without first getting FDA approval. As a result, GPhA has proposed the Expedited Agency Review (EAR), which relies on the FDA to review new safety information and take action on label changes. 
 
“The FDA is the only entity with all of the data needed to recommend a safety information change,” David said. “Instead, the EAR suggests time parameters for the FDA to take action and encourages the adoption of e-labeling for real time information sharing rather than continuing the reliance on paper label changes that take months or years to adopt. The EAR also takes important steps to make sure that multiple different labels do not exist for products with the same active ingredients, safety and efficacy.”
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New HDMA report snapshots state of specialty pharmacy distribution

BY David Salazar

ARLINGTON, Va. — The seventh edition of HDMA’s report on specialty pharmacy distribution, compiled by its Center for Healthcare Supply Chain Research. The 2015 edition of “Specialty Pharmaceutical Distribution: Facts, Figures and Trends is sponsored by CuraScript Specialty Distribution, Genentech and Pharmacy first, and contains insights on the state of specialty, which IMS Health valued at $124 billion in the United States in 2014.

“The Center is pleased to add the latest edition of this publication to its growing body of research on this unique pharmaceutical segment,” said Karen J. Ribler, Executive Vice President and COO of the Center for Healthcare Supply Chain Research. “As noted in this new edition, specialty distributors continued to provide extraordinary service levels to their manufacturer and dispenser trading partners, creating overall supply chain efficiencies.”

According to the report, from 2009 to 2014, branded and generic specialty sales in the United States grew at an annual compound growth rate of 12%. And the dominant force in the specialty category continues to be oncology medication, which made up 46,.3% of sales volume for distributors in 2014. Sales to physician-owned and –operated clinics went up 70% in 2014, with sales to hospitals and hospital-owned clinics dropping to 17% and 4%, respectively.

In terms of supply chain, the typical HDMA member distributor picked an average of 12,000 lines in a business day at a fill rate of 99.4%. In an average of 17 hours, the distributors ship to 27,000 unique points, with about 1.1% of selling unites being returned. Respondents who are distributors noted contracts with more than 150 manufacturers. 

The full report can be purchased through the website for the Center for Healthcare Supply Chain Research. 

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Report predicts $1.5 billion global photo kiosk market by 2019

BY David Salazar

PUNE, India — Despite the shift to digital photography over film, there’s still hope for stores with photo kiosks, as a new report on the photo kiosk market predicts that it will reach $1.5 billion globally, with retail stores composing 51% of the market share. Additionally, stores like Rite Aid, Costco, Target, Walgreens and Walmart will be key players in the market. 
 
The report, from ReportsnReports, highlights the role that consumer interest in instant services provided by photo kiosks as being a key driver in the market. Being able to send kiosks a photo from their phone and receiving an instant print is preferable to waiting for film to be developed, the report says. Additionally, customized gift printing, including greeting cards, calendars and photo albums that kiosks can produce, is driving market growth. 
 
In terms of geography, the report suggests that market share will be focused in the Americas, due in part to an increased demand for kiosks in retail, entertainment, travel and healthcare industries. 
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