Biogen Idec hopes treatment will be first advance in hemophilia B treatment in 15 years
WESTON, Mass. — Biogen Idec is seeking Food and Drug Administration approval for a hemophilia drug that it called the first of its kind.
The drug maker announced that it had submitted a regulatory application for recombinant factor IX Fc fusion protein, or rFIXFc, which it called the first long-lasting factor IX therapy for hemophilia B.
"The submission to FDA of rFIXFc is an important milestone towards the introduction of a long-lasting factor IX therapy, which is the first major treatment advance for the hemophilia B community in 15 years," Biogen Idec SVP global medical affairs and chief medical officer for the company’s hemophilia therapeutic area Glenn Pierce said. "Our Fc fusion technology uses a natural pathway in the body to keep factor in circulation longer."
NCPA and others will need to bring freshman Congress class up to speed in record time
The National Community Pharmacists Association last week noted that language in the "fiscal cliff" legislation that averted the worst of potential tax consequences for individuals nonetheless had a chance to negatively impact diabetics who buy their supplies from their local community pharmacy.
So while Wall Street was rocking and rolling last week on the news that the economy wouldn’t be hurdling down the same road traveled by Thelma & Louise, at least not yet, the news brought to light another issue — the new Congress, with its freshman class of 97 legislators, will be addressing plenty of mature problems — such as the consequences of not exempting independent pharmacies from competitive bidding when it comes to durable medical equipment and diabetes supplies.
So here’s a quick refresher, courtesy of the Office of Inspector General. It’s a document released on Nov. 7, 2012 that "appears to reinforce three things about mail order health care: 1) it’s not for everyone; 2) it results in wasteful “auto-shipping” of medical products; and 3) it’s more expensive than advertised," according to an article published in NCPA’s The Dose.
In a nutshell, the OIG found that the use of non-mail order sources for diabetic testing supplies increased by 33% when competitive bidding was implemented. Why? Well, 10% switched because they didn’t like mail, according to the report in The Dose, and 5% switched because mail order sent them supplies they never really needed in the first place.
In the event that you are a show-me person, and would like to see what kind of waste of diabetes supplies can accumulate via mail order, check out this YouTube video posted by Oklahoma pharmacist Todd Pendergraft of Broken Arrow Family Drug.
Lobbying groups like NCPA and others are going to have their work cut out for them this year as they bring all the freshman Congress leaders up to speed on pertinent health delivery issues. And time is of the essence, with states and employers preparing for the implementation of the lion’s share of healthcare reform less than one year from now.
What are your key issues? When targeting the 2013 freshman class, what should NCPA’s government relations team be focusing on?
FDA approves new delivery method for MS drug
NEW YORK — The Food and Drug Administration has approved a new means of administration for a multiple sclerosis drug, the manufacturers said.
Pfizer and EMD Serono announced the approval of Rebif Rebidose (interferon beta-1a), a single-use auto-injector for self-administering Rebif, used to treat relapsing forms of MS. EMD Serono is the U.S. division of German drug maker Merck KGaA, so-named to avoid confusion with U.S.-based Merck & Co.
"We are pleased to announce the FDA has approved Rebif Rebidose, which provides people living with relapsing MS another option to meet their injection needs," EMD Serono president James Hoyes said. "The introduction of Rebif Rebidose underscores our commitment to the MS community and to our investment in the development of delivery devices to assist with ease of use and support those living with MS."