FDA raises generic drug user fees for 2014
WASHINGTON — The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.
According to the Federal Register, the daily journal of the U.S. government, the FDA announced new rates for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program.
The new fee for an ANDA is now set at $63,860, up approximately 24% from the current $51,520. The PAS will similarly be raised by 24%, to $31,930. The FDF fee increased to $220,152, a jump of 25%. The largest percent increase hit the DMF fee, which rose nearly 48% to $31,460. However, the API fee was lowered to $34,515.
FDA now refunds 75% of the original filing fee in all instances of refuse-to-receive with the exception of failure to pay fees. Therefore, an application that is refused on the first attempt, amended, refiled and accepted for review would pay a total of $78,825, or 125% of the standard amount. - Penina Mezei Americare
Cardinal Health highlights independent pharmacy Best Practices at Retail Business Conference 2013
SEATTLE — At its annual Retail Business Conference for independent pharmacies, Cardinal Health presented its special publication Independent Pharmacy Best Practices Guide: Innovating Independents. This report highlights 14 unique programs, implemented by independent pharmacists from across the United States, that improve patient care and drive business results.
Cardinal Health provides pharmaceutical distribution and a vast array of business support services to more than 7,500 independent pharmacies from across the United States. The company invited its independent pharmacy sales force to nominate successful best practices from their customers. Retail pharmacy experts from Cardinal Health then selected 14 stories to be highlighted in this issue of Independent Pharmacy Best Practices, and invited members of its Retail Advisory Boards, which are comprised of leading independent pharmacists from across the country, to select three finalists.
At RBC 2013’s Industry General Session, event attendees viewed videos highlighting the three finalists and were invited to ‘text to vote’ for the most innovative best practice. The winners of the text-to-vote competition were Kasey Woods and Amy Brian of Midtown Pharmacy in Whitsett, N.C., and Cardinal Health will donate $7,000 to the Medical University of South Carolina College of Pharmacy in their honor.
The company will also donate $2,000 to Southwestern Oklahoma State University’s College of Pharmacy in honor of second-place winner Amy Carothers of Daniel’s Drug and Wellness Pharmacy, in Guthrie, Okla.; and $1,000 to Drake University’s College of Pharmacy in honor of third place finalists Sam and Samantha Zoske of Medicap Pharmacy 8004 in Marshalltown, Iowa.
The three independent pharmacies that were recognized as finalists at Cardinal Health’s Best Practices Text-to-Vote competition at RBC 2013 are:
- Diabetes University – Kasey Woods and Amy Brian, Midtown Pharmacy, Whitsett, N.C. – Several years ago, Midtown Pharmacy recognized the need for education to help persons with diabetes and their caregivers improve their quality of life. The store uses a series of educational presentations and resources, developed by Cardinal Health, to offer once monthly classes for diabetes education and support. Amy Brian, a pharmacist at Midtown Pharmacy and a certified diabetes educator (CDE), coordinates the program. Although many participants are not initially Midtown customers, Brian says they often transfer their prescriptions to Midtown after participating, as a result of their confidence in the pharmacy’s knowledge and outstanding level of care. This program also boosts sales of diabetic supplies and increases patient compliance with their medications. Four weeks after a patient completes the program, the store conducts follow-ups by phone, as well as a 4-6 month follow up to check patient progress toward goals set during instruction. “It’s important that we don’t just grab these patients, educate them for a few hours and then turn them loose. We want to provide them ongoing education so that they are constantly learning. Ultimately, this builds loyalty to our store and keeps them coming back,” says Brian. Midtown Pharmacy has successfully marketed the program, the cost of which is covered 100 percent by Medicare and Medicaid, by connecting with doctor’s offices for referrals, via their website and through word-of-mouth advocacy.
- Hormone Testing and Treatment Program – Amy Carothers, Daniel’s Drug and Wellness Pharmacy, Guthrie, Okla. –Daniel’s Drug and Wellness Pharmacy began compounding specific hormone therapies for patients to meet their community’s growing need for customized medication. They coupled this new service with monthly seminars for women, giving them more information about hormone therapies and choices as well as in-home and video educational counseling. Store owner and pharmacist Amy Carothers says, “We are health advocates for our patients. After my own personal struggle with infertility, I wanted to help women understand their bodies and hormones. I believe that patients need to take charge of their own lives. They need to educate themselves on their health and their medication options.” Daniel’s Drug and Wellness went from filling 20-30 compounded prescriptions per month to 200-300 per month by offering hormone education to customers, dramatically increasing profits.
- Prescription Auto Fill Program – Sam & Samantha Zoske of Medicap Pharmacy 8004, Marshalltown, Iowa – Medicap Pharmacy 8004 faced low margins and tight cash flow issues in its small town. To address these challenges, the store used Cardinal Health’s Inventory Manager to analyze their dispensed medications and develop a prescription auto fill program. Store owner Sam Zoske says the program eliminates patients’ wait time for prescriptions and helps increase the likelihood that they’re medication compliant. The program has also successfully reduced inventory by 40 percent and decreased inventory cost by nearly $140,000 in the last year. After a patient is signed up, a pharmacist simply notifies the patient when a prescription is ready via email, phone or text, based on preference. The store currently has 40-50 percent of its patient base signed up for this program and markets it to all potential new patients.
“The independent pharmacists we serve are always striving to provide high-quality, personalized care to patients while positioning their businesses to succeed,” said Steve Lawrence, senior vice president of independent sales for Cardinal Health. “We’re delighted to honor this year’s winner and finalists by sharing their best practices at RBC 2013, and we congratulate them for their commitment to community pharmacy excellence.”
Hard copies of Independent Pharmacy Best Practices 2013, Innovating Independents, are available to all attendees of RBC 2013 and online.
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Bartell Drugs announces 10th annual drive for school supplies
SEATTLE — Bartell Drugs announced today its “School Tools for Kids in Need” drive — a helping hand for teachers assisting local students with school supplies, running now through Aug. 31.
Bartell Drugs is welcoming donations of school supplies for its 10th annual “School Tools for Kids in Need” at 59 Bartell Drugs locations. The drive supports students in King, Pierce and Snohomish counties through World Vision’s Teacher Resource Center in Fife.
Donated school supplies will help re-stock the Teacher Resource Center, where teachers — whose students qualify for free or reduced-price lunch programs — “shop” free of charge for school supplies to help meet students’ needs.
According to Federal Way-based World Vision, a globally-known charitable organization, as many as 58,000 local students could begin the school year without some basic school supplies.
“With so many area children lacking basic school supplies, there’s never been a more important time to support this drive. Over the past eight years we’ve appreciated the support by our customers and the public for their donations,” said Bartell Drugs chairman and CEO George D. Bartell.
Mead, Avery, Kimberly Clark and Bic have teamed up with Bartells to support this year’s “School Tools for Kids in Need” drive. A “Basic Needs” list of suggested donation items found in Bartell’s “School Aisles” include:
- #2 Pencils – 10 Count;
- Bic Cristal or Stic Round Ink Pens – 10 pack of blue or black;
- Elmer’s Glue – School Glue/4 oz. bottles;
- Scotch Kids’ Scissors – pointed or blunt;
- Avery Glue Stic – Acid-free, photo-safe, permanent and washable;
- Avery Poly Binders –1” size Crayola Crayons – 16 count;
- Avery Hi-Liter Markers – Yellow or Pink;
- A&W Zipper Pencil Pouch;
- Mead Index Cards;
- Crayola Colored Pencils – 12 count.
Founded in Seattle in 1890, Bartell Drugs owns and operates locations in King, Snohomish and Pierce counties. Family-owned and operated, it is the nation’s oldest drug store chain.
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