FDA submits recommendations for Generic Drug User Fee Act
WASHINGTON — The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.
GDUFA calls for the generic industry to pay $299 million per year for five years, in addition to what Congress gives the FDA. The money would come in the form of user fees for companies that submit regulatory approval applications to the agency for review.
Over the years, the agency has racked up a backlog of more than 1,000 generic drug approval applications and, according to the Generic Pharmaceutical Association, it takes 31 months for the FDA to review an application submitted electronically. Supporters, such as the GPhA, hope that GDUFA will help reduce the wait time to 10 months and eliminate the backlog by the end of fiscal year 2017.
"This is an important landmark that could not have been achieved without the extraordinary efforts of the FDA, my colleagues in the generic industry and all other stakeholders," GPhA president and CEO Ralph Neas said. "We now look forward to working with members of Congress in the weeks and months ahead to ensure that the final program is one that expedites access to low-cost, high-quality generic drugs for Americans and further safeguards the quality and accessibility of our nation’s drug supply."
Walgreens taps out a little bit of sunshine in last week’s meetings
WHAT IT MEANS AND WHY IT’S IMPORTANT — It couldn’t have been choreographed better if Bob Fosse himself had orchestrated Walgreens’ annual shareholders’ meeting. It started on Monday, Jan. 9, when Walgreens’ executive team entertained reporters to unveil the latest flagship location on State and Randolph. That evening, Illinois governor Pat Quinn and Chicago mayor Rahm Emanuel stood with flagship architect Joe Magnacca and officially christened the new store before Tuesday’s grand opening. And after, shareholders had an opportunity to taste the new Walgreens fare for themselves, the week’s affairs ended with a state-of-the-pharmacy address from Greg Wasson on Wednesday that focused more on Walgreens’ future and less on Walgreens’ future without Express Scripts.
(THE NEWS: Walgreens outlines five key strategies to change the pharmacy retail industry. For the full story, click here. To check out DSN‘s comprehensive pictorial store tour of the latest flagship, click here.)
Walgreens has set the stage for a new kind of pharmacy. Last year Wasson stated that one of Walgreens’ objectives was to own "well." And this year, Walgreens is delivering that "well experience," in part through what Wasson described as a "cutting edge design with improved product assortment" combination.
But Walgreens’ showstopper can be found in those flagship stores, indeed across all of its "well experience" stores, as the pharmacy operator attempts to advance the role community pharmacy plays in the delivery and application of overall healthcare by bringing out America’s most-trusted healthcare professional permanently from behind the pharmacy counter to be center stage with the patient.
And so far, it’s working. "Never in my 31 years with this company have I ever seen customer satisfaction jump like it does in these [well] experience stores," Wasson told shareholders.
But even with all the new store format fanfare last week, Express Scripts still loomed across the backdrop as Walgreens’ top officials defended its decision to walk away from that PBM’s pharmacy network. "It was the right decision for you our shareholders [and] our employees I can assure you," Wasson said.
What was not said was as important as to what was said, however. There were no apologies — no Mary Sunshine or any of that jazz. Walgreens’ executives unabashedly told shareholders — yes, the loss of any Express Scripts prescriptions will hurt this chain’s bottom line in the short term. But Walgreens is committed to the long term, and the future of Walgreens, indeed the future of the "well experience" is as bright and sunny as ever without the need for any rose-colored glasses.
Walgreens, Career Step partner to provide externships
PROVO, Utah — Pharmacy technician students at an online school will be able to perform externships with a major retail pharmacy chain, under a partnership the two companies announced.
Career Step said it would partner with Walgreens to allow students to work at local Walgreens stores after gaining a solid foundation of pharmacy technician knowledge in the program. Externship will typically consist of 180 practical hours.
"These externships are a phenomenal opportunity for our students," Career Step pharmacy technician instructor Rebekah Hutchins said. "The Career Step pharmacy technician training program already incorporates a variety of teaching methods — including video, simulations and interactive exercises — and now these externships are adding hands-on experience in the real world for our students to thoroughly learn the material and prepare for certification and employment."