Reports: GDUFA implementation may hit delays
NEW YORK — The generic drug user fee program may have hit a speed bump due to budget problems in Congress, according to published reports.
Bloomberg reported that implementation of the law may be delayed because Congress must first pass legislation authorizing the Food and Drug Administration to collect money from generic drug companies, but the problem is that members of Congress will leave Washington this week, not to return until after the Nov. 6 elections.
The Generic Drug User Fee Amendments, part of the renewal of PDUFA that president Barack Obama signed in July, will collect $299 million per year in user fees from generic drug companies over the next five years starting on Oct. 1. This, drug makers and agency officials hope, will help the FDA reduce a backlog of more than 2,000 generic drug approval applications and ensure faster review of future applications.
Valeant buys eye drug for $112.5 million
MONTREAL — Valeant Pharmaceuticals International has acquired rights to a drug used to treat a symptom of age-related macular degeneration, the drug maker said.
Valeant announced that it acquired the injected drug Visudyne (verteporfin) from QLT, a company based in Vancouver, Canada.
Valeant said it paid $62.5 million upfront for all U.S. rights and available inventories for the drug, which had U.S. sales of about $21 million in 2011, and another $50 million upfront for rights to non-U.S. sales, which were about $14 million.
Kroger’s Giving Hope a Hand campaign commits $3 million toward breast cancer awareness
CINCINNATI — For the sixth consecutive year, Kroger has committed $3 million in donations for local breast cancer initiatives across the country to support National Breast Cancer Awareness month in October as part of its Giving Hope a Hand initiative.
Kroger received a 2012 Gold HALO award from the Cause Marketing Forum for the company’s annual Giving Hope a Hand campaign. The effort kicked off in stores on Sept. 23 and features 48 Kroger associates who are breast cancer survivors on marketing materials and custom packages of national and Kroger corporate brand products. These women share their survivor stories on the packaging of select items sold exclusively in Kroger’s family of stores. Kroger associate Janie Weber, who works as a front end/floral clerk for Dillons Division in Newton, Kansas, is featured this year on Kroger bottled water.
"The Kroger family applauds the willingness of our associates to share their personal stories as breast cancer survivors," stated David Dillon, Kroger’s chairman and CEO. "Their participation in this unique campaign inspires, educates and offers courage to our customers and other associates who are affected by this disease."
At the end of this year, Kroger will have donated more than $21 million to support breast cancer research, education and services since Giving Hope a Hand began in 2006.
Kroger’s campaign features a storewide sales promotion of popular items, many of which will feature exclusive, specially marked pink packaging. This year, 1,600 items — including Kroger’s own products and popular items from Kroger partners, such as Energizer, Freschetta, General Mills, Greenlite, Kellogg’s, Kimberly Clark, Kraft, Pepsi, Purina, Sargento and SC Johnson — will be marked with special shelf tags to highlight participation. The full list of partners can be viewed at SharingCourage.com/Our-Partners.aspx.