For those who are superstitious it is Friday the 13th. Lately, for some, it seems that characterizes every day as it has been an active week on the bad news front for many. Here in the Beltway, Congress is back in session and took the FDA to task yesterday over the agency’s response to the pet food problem. Meanwhile, I try to figure out how to get my plants off my dining table and into the garden in between Spring snow squalls. And here is what else happened this week.
- FDA Approves First Biologic to Prevent Hepatitis B Reinfection in Transplant Patients - The agency announced the approval of HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant
patients. HepaGam B is the first product of its kind (an immune globulin product)
approved for this purpose. According to the press release "HepaGam B works by providing an immediate immune response to the virus. This
immunity protects patients previously exposed to HBV. Patients must receive
injections at the time of their liver transplant and throughout their lives.
This product is manufactured from human plasma collected at U.S. licensed plasma
centers from healthy donors. HepaGam B is manufactured by Cangene Corp. of Winnipeg, Canada.
- FDA Provides Web Page on Post-Approval Device Studies -The agency set up a new Web page
that will keep the public informed about the status of post-approval patient
studies for certain recently approved medical devices. A link has been provided in the column to the left on the blog entitled FDA Links.
- Pet Food Recall Expands Yet Again and Tainted Food May Still be on Shelves – The FDA announced that its inspectors have found some of the food that was to have been recalled still on the shelves. I commend them for looking for this stuff, it can’t be easy – but still the news is disturbing and the parameters of this recall are ever expanding.
- FDA to Hold Hearings on MedGuide Program - Medication Guides are a risk management tool often handed out with prescriptions to give the patient further insight into the use of the product. The FDA is going to hold a hearing on MedGuides with a goal of improving risk communication. I think this is an interesting first-step, but really a longer meeting, or a series of meetings need to be held about risk management in general. I don’t think the agency truly knows the efficacy of a Black Box Warning in risk management, but continues to slap them onto products. I think there needs to be a thorough review of risk management practices – what works, what doesn’t and what can be done to make interventions more effective. But in the meantime, if you are interested in attending this session, here are the details.
That’s it folks. Look for another podcast on Monday, this one planned on reimbursement issues. In the meantime, have a wonderful weekend.