PDUFA reauthorization goals draw support from NACDS
ALEXANDRIA, Va. — A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country’s main chain retail pharmacy lobby.
The National Association of Chain Drug Stores submitted written testimony Tuesday ahead of a congressional hearing on the reauthorization of PDUFA, originally enacted in 1992.
Specifically, the group endorsed its goals to have the Food and Drug Administration review drug applications for similarity in drug brand names that could result in medication errors and integrate REMS programs into the healthcare delivery system. The testimony also highlighted such policies as medication therapy management and cracking down on illegal sales of drugs on the Internet.
"We believe that REMS should be subject to review by pharmacies and other relevant healthcare providers, such as by a representative panel of expert reviewers to include pharmacists who practice in pharmacy settings affected by the REMS," the testimony read. "Although pharmacies are not directly responsible to FDA for the design, implementation and success of REMS, pharmacies are subject to the elements of REMS in order to meet the needs of their patients."
New hire at Walgreens underscores ‘real opportunity’
DEERFIELD, Ill. — Viewed through an Express Scripts lens, Walgreens’ new hire announcement — naming Robyn Peters to group VP managed market sales — may appear timely. The drug store chain is approaching an aggressive marketing overture behind its entire lineup of healthcare proficiency during the first pharmacy benefit manager selling season that it is no longer part of the Express Scripts pharmacy network.
Walgreens’ definitely has its timing down, but this has less to do with Express Scripts and more to do with the fact that Walgreens in the past year has streamlined all of its healthcare functionality under one umbrella so that they can proposition one cohesive retail healthcare offering to employers and payers, Walgreens executives told Drug Store News.
"As our healthcare strategy has been evolving … and the healthcare landscape has gotten more complex, we have been thinking long and hard about fully integrating our approach to the payer community, whether that be employers large and small, PBMs — large, medium and small — the health plans segment, the government segment, the health systems segment," said Jeff Berkowitz, Walgreens SVP pharmaceutical development and market access, in an interview following yesterday’s announcement. "We have an extraordinary value proposition to put a selling effort behind," he added. That selling proposition is everything from Walgreens’ entire "Well" experience — representing the integration of the front-end into that experience across Walgreens’ new store designs — to the retailer’s multichannel approach (think iPhone, Facebook, etc.). Behind the bench, in addition to a typical retail pharmacy experience (e.g., medication therapy management, healthcare counseling), Walgreens has 90-days-at-retail, a specialty pharmacy model and home infusion capability in several markets. There’s also Walgreens’ Take Care Health retail clinics and worksite clinics, along with Walgreens’ commitment to offering immunization services.
"What this integrated model allows us to do is go to the payer community and not just focus on the 10% or 8% that is the drug spend, but really partner with and focus with them on their entire medical spend and how to lower that," Berkowitz said. "That’s the real opportunity here."
FDA approves Vertex’s Kalydeco for cystic fibrosis
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.
The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.
CF is a serious disorder that leads to an early death by causing thick mucus to build up in the lungs, digestive tract and other parts of the body, eventually leading to respiratory and digestive problems and such complications as infections and diabetes. Of the 30,000 people in the United States with the disease, about 1,200 are estimated to have the G551D mutation.
"Kalydeco is an excellent example of the promise of personalized medicine — targeted drugs that treat patients with a specific genetic makeup," FDA commissioner Margaret Hamburg said.