Senate votes down Durbin supplement regulation by almost 4 to 1
WASHINGTON — Dietary supplement industry champion Sen. Orrin Hatch, R-Utah, last week led efforts to strike down an amendment that would have dramatically overregulated the dietary supplement industry.
The Senate voted 77-20 to table an amendment to the pending FDA Safety and Innovation Act that was proposed by Dick Durbin, D-Ill. The amendment would have expanded the current registration requirements for anyone involved with the manufacturing, processing, packaging or storage of dietary supplements to register with the Food and Drug Administration. The Durbin Amendment also would have required that all registered facilities would need to submit to the FDA a list of all ingredients for each of the products they sell as well as a copy of every label.
Speaking on the Senate Floor in advance of a vote on the Durbin Amendment, Hatch said the Amendment “is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products.” Hatch added that instead of allowing the FDA to utilize the resources it already has under DSHEA, the Durbin Amendment “serves to punish all responsible companies with its overreaching mandates.”
Mylan launches generic Lipitor
PITTSBURGH — Mylan on Tuesday announced that its subsidiary has received final approval from the Food and Drug Administration for its abbreviated new drug application for atorvastatin calcium tablets, a generic version of Pfizer’s Lipitor.
The drug maker said Mylan Labs (formerly Matrix Labs) received the go-ahead to market the drug in the 10-mg, 20-mg, 40-mg and 80-mg strengths. Lipitor had U.S. sales of $8.1 billion for the 12 months ended in March, according to IMS Health.
"We are very pleased to have received final approval for our ANDA for generic Lipitor, the most widely prescribed drug in U.S. history," Mylan CEO Heather Bresch said. "Through Mylan’s launch of atorvastatin calcium Tablets, we look forward to be able to offer our customers, the American consumer and the U.S. government significant savings and expanded access to this important product."
NCPA to hold annual convention and trade expo this fall in San Diego
ALEXANDRIA, Va. — The National Community Pharmacists Association is slated to host its 114th annual convention and trade exposition this fall in San Diego.
Held Oct. 13 to 17 at the San Diego Convention Center, NCPA said its annual meeting will present the latest in pharmacy education, case studies and real world, business-impacting information for the independent community pharmacy industry and will tout the theme of "Meet. Learn. Succeed.," which reflects the top goals of the meeting for the representatives of more than 3,000 community pharmacies who attend each year. The show also will feature nearly 20 hours of continuing education credits on such topics as marketing, adherence, technology and pharmacy-sustaining niches, including long-term care, immunizations, compounding and more. New this year will be daily non-CE business basics with NCPA senior director of sales and marketing Gabe Trahan, who will lead business breakfast discussions and identify the top five products of the day on the tradeshow floor and help attendees learn how to merchandise them back home in their pharmacies.
The NCPA also said the event’s keynote speaker will be former congressman Joe Scarborough, R-Fla., host of MSNBC’s "Morning Joe."
"We are excited as always to bring practical business and advocacy solutions to community pharmacists, with experts and content to help improve the bottom line," NCPA president and Oklahoma City pharmacy owner Lonny Wilson said. "Our convention programming reflects those values."