FDA approves exocrine pancreatic insufficiency treatment
ABBOTT PARK, Ill. The Food and Drug Administration has granted an additional approval to a pancreatic enzyme drug made by Abbott, the drug maker said Monday.
The FDA approved Creon (pancrelipase) delayed-release capsules for limited production of pancreatic enzymes due to chronic pancreatitis and removal of the organ. Limited production of pancreatic enzymes prevents proper digestion of food. The drug was already approved in May 2009 for patients with exocrine pancreatic insufficiency due to cystic fibrosis.
“Without proper dosing guidance, some patients have previously attempted to control EPI symptoms by modifying their diets and limiting fat intake,” National Pancreas Foundation executive director Orelle Jackson said in a statement on behalf of Abbott. “However, this approach has yielded limited treatment success.”
Avanir addresses the FDA’s concerns over Zenvia
ALISO VIEJO, Calif. Drug maker Avanir Pharmaceuticals has responded to the Food and Drug Administration’s concerns over a drug for treating a disease that causes bouts of laughter and crying in patients, Avanir said Friday.
Avanir said it issued a complete response to the FDA’s approvable letter from October 2006 for the drug Zenvia (dextromethorphan and quinidine), a treatment for pseudobulbar affect. “Approvable letter” is the former name for what the FDA began calling a “complete response letter” in 2008. A complete response letter means that the FDA has finished reviewing a drug company’s approval application, but questions remain that preclude final approval.
The company said it expected the FDA to grant it a review period of six months, allowing the approval of Zenvia in fourth quarter 2010.
NACDS Annual underscores value of pharmacy
WHAT IT MEANS AND WHY IT’S IMPORTANT The idyllic Palm Beach setting is splendid. The weather usually is sunny and sublime. And the service, food and amenities served up by The Breakers nearly always are flawless.
(THE NEWS: Time to assert pharmacy’s role, new NACDS chairman urges. For the full story, click here)
Ditto for the smoothly run meeting itself, which is a testament to NACDS’ unparalleled organizational abilities and highly competent staff. NACDS always makes running this massive, four-day event look easy – when in fact it must resemble, behind the scenes, the logistical challenges of a full-scale military operation.
All told, there are certainly far less pleasant settings in which to gather the industry’s top decision-makers for a rare chance to meet top-to-top, share ideas, iron out problems and mull the biggest challenges confronting retail pharmacy. But the work of Annual and the issues the attendees grapple with at The Breakers are no stroll on the beach.
In his first address as newly elected NACDS chairman, CVS/pharmacy president Larry Merlo reminded industry leaders why they really made the trek to Palm Beach. In an era of unprecedented challenges to the healthcare system, unsustainable growth in health costs and the uncertainties of a shiny new health-reform law, he said, “the time is now to examine the trends in the delivery of health care and the role of community pharmacy, not just today but into the future as well.”
For the leaders who heard Merlo’s speech, taking a hard look at “the role of community pharmacy” isn’t just an exercise in professional turf-building or some blue-sky theorizing about the future of the profession. As policymakers, patients and publicly and privately funded health plan payers search desperately for ways to deliver more effective, locally based patient care and disease management at lower costs, the role of the community pharmacist is a critical question. It goes to the heart of the retail pharmacy industry and its ability to survive.
Merlo’s address summed up the serious purpose that lay behind the annual Palm Beach gathering. “Most important of all,” he reminded NACDS members, “we must ensure that the value of the pharmacy industry and its pharmacists are recognized by payer reimbursement policies: not just for the products we sell, but for the services we provide.”
The meeting was also a chance for the industry to honor some of the best among its own ranks. This year’s choices for the Robert B. Begley Award and the Sheldon W. Fantle Lifetime Achievement Award didn’t disappoint: both awards went to individuals who represent the best qualities of people-oriented leadership in retail pharmacy and health-and-wellness product sales.
When Merlo announced that Charlie Burnett and Stanley Barshay had been chosen as this year’s recipients, both men and their wives ascended the stage to thunderous applause. Barshay, honored with the Begley Award, was recognized for his distinguished career at Schering-Plough and American Home Products, his ability to grow business for both the companies he represented and the retail chains he helped supply, and, not least, for his personal warmth and integrity.
Burnett, the only individual to be honored with both the Fantle Award and the NACDS Harold W. Pratt Award for his efforts on behalf of pharmacy, was a clear favorite for the night’s retail honor. A former U.S. Navy corpsman, he has been integral to pharmacy retailing since the 1950s.
When Costco founder and CEO Jim Sinegal lured Burnett to his company in 1986 to develop the warehouse club giant’s fledgling pharmacy business, Burnett brought a wealth of big-box retail pharmacy experience from his years with FedMart and Save Mart Supermarkets.
Sinegal gave a touching speech in a surprise appearance on stage at the awards ceremony Tuesday night, telling well over a thousand NACDS attendees that Burnett’s devotion and leadership were the reason Costco was a success in U.S. pharmacy retailing. “I knew Charlie was the right man to grow our pharmacy business,” he said.