GPhA responds to potential OGD funding cuts; announces exit of Gordon Johnston
WASHINGTON — The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.
Republicans in Congress have sought to reduce government spending by making large cuts to various domestic programs and agencies, including the FDA, which critics of the plan said could jeopardize food and drug safety.
In a letter to Republican House speaker John Boehner, Democratic Senate majority leader Harry Reid, and Office of Management and Budget director Jack Lew, the Generic Pharmaceutical Association wrote that the OGD has a backlog of more than 2,000 generic drug applications, including up to 365 first-to-file applications — a backlog that results in consumers and the government having to pay more than $200 for branded drugs because the generic versions remain unavailable.
“While we understand the difficult budget environment in which Congress is operating, the timely approval of additional generics would generate federal savings that far exceed the cost of fully funding the generic drug program,” the GPhA said.
In other news, the GPhA said Monday that VP regulatory sciences Gordon Johnston would resign and serve as senior adviser for regulatory sciences starting in April. Johnston took the VP regulatory sciences position in 2003. He has worked in the drug industry for more than 25 years and retired from the FDA in 1999 to serve as an industry consultant.
“Gordon’s commitment and contributions to the generic pharmaceutical industry over the years cannot be overstated,” GPhA chairman and Watson Pharmaceuticals president and CEO Paul Bisaro said. “He has helped increase communication and interaction with the FDA, implemented many programs that have helped our association play a critical role in quality and has been instrumental in preparing [the] GPhA to participate in the upcoming generic user fee negotiations. It’s impossible to adequately express our thanks for his tireless support of the generic industry and his outstanding service — not only for the association but also during the years he served in the FDA Office of Generic Drugs.”
Kerr Drug boosts free delivery program with new website
RALEIGH, N.C. — Customers looking to take advantage of Kerr Drug’s free delivery service now can visit a new website developed by the chain.
By logging on to KerrDrugDelivers.com, customers can find the nearest Kerr Drug pharmacy to request free delivery. The service allows customers to find the nearest Kerr Drug pharmacy and phone number to call and order their prescriptions, along with anything else in the store they may need.
“Free delivery became a popular service as soon as we started the program, and our new Web locator makes the service even easier to use,” said Tony Civello, president and CEO of Kerr Drug. “There are circumstances when customers can’t get to the pharmacy, and providing free delivery is another way to better serve the community, which is what the concept of community pharmacy is all about.”
Kerr Drug launched the free delivery service in September 2010, and extended the program last December.
Report: Mylan looks to block Ranbaxy from making generic Lipitor
NEW YORK — Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.
Bloomberg reported that Mylan said in a complaint filed in federal court in Washington that because of past manufacturing violations at two of Ranbaxy’s factories in India, other companies should be able to launch versions of Lipitor (atorvastatin) once Pfizer’s patent expires in June. The FDA restricted certain imports from Ranbaxy’s plants in India in 2008 and 2009 after an inspection of plants in Dewas and Paonta Sahib turned up current good manufacturing practice violations there. The FDA also had found cGMP violations at the Paonta Sahib plant in 2006.
Ranbaxy, mostly owned by Japanese drug maker Daiichi Sankyo, has been slated to launch a generic version of Lipitor this year since 2008, under an agreement with Pfizer. Under FDA regulations, Ranbaxy would be entitled to six months in which to compete directly with Pfizer, after which the atorvastatin molecule would become fair game for any generic manufacturer. But Mylan is hoping to use Ranbaxy’s past cGMP violations to expedite the process.
A victory for Mylan would be a major loss for Ranbaxy given Lipitor’s status as the world’s top-selling drug, with annual sales of more than $7 billion in the United States alone, according to IMS Health.
In other news, Bloomberg reported that the Supreme Court rejected Mylan’s challenge to Daiichi Sankyo’s patent on the hypertension drugs Benicar (olmesartan) and Azor (olmesartan and amlodipine).