We have arrived at mid-April – significant for so many things. One – we avoided a government shut-down this week. That’s good. This month we saw the anniversaries of the start of the Civil War and the end of the Civil War. Today is the date that President Lincoln died on 10th Street here in Washington, D.C. Normally it would be tax filing deadline day, but that has been extended this year until April 18 because of Emancipation Day here in the District, which is also today.
And here is a bit of what happened in our world this week:
- FDA Approves New Treatment for Large Brain Aneurysms – That is the way the FDA press release ran the headline, but I actually don’t think they were meaning to suggest aneurysms in large brains, but rather large aneurysms. The treatment is called cPAX Aneurysm Treatment System and it is utilized for surgery on brain aneurysms that are difficult to manage because of their size and shape. The cPAX Aneurysm Treatment System is manufactured by Neurovasx Inc., Maple Grove, Minnesota.
- FDA and the Device Approval Process - A lot was said this week by a lot of people about the need for the FDA to modify the approach to device approvals. Some of it was said at a Senate hearing before the Special Committee on Aging and you can watch the entire hearing if you like. The GAO, for example, reporting on progress since its 2009 report on the same topic, submitted testimony stating that the agency was allowing too many approvals without necessary scrutiny to enter the market, among other things. Also testifying before the committee was William Maisel, M.D., Deputy Center Director for Science, CDRH, where he cited progress on the part of the agency in regulating devices. Congresswoman Rosa DeLauro on the same day of the hearing issued a letter to FDA calling for an improved regulatory process.
- FDA’s Screening Efforts at the Border – On the very same day, across the Hill, Commissioner Hamburg was also visiting Congress offering her remarks before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce about the FDA’s screening efforts at the U.S. borders. She stated some stark facts about the reality of where the things we swallow – food or medicine – come from. Here they are: ”It is estimated that 15 to 20 percent of all food now consumed in the United States originates outside our borders. In fact, over 70 percent of seafood and about 35 percent of fresh produce consumed in the United States comes from foreign countries. Further, up to 40 percent of the drugs Americans take are manufactured outside our borders, and up to 80 percent of the active pharmaceutical ingredients in those drugs comes from foreign sources. Imported medical devices are another rapidly growing area.” To this she added another stark reality – “In addition to the sheer volume of imports and foreign facilities producing FDA-regulated commodities, there has been an increase in the variety and complexity of imported medical products.” The task is not enviable and in my mind, one has to ask even if it is doable and sustainable. It is a particularly valid question given the reluctance of many conservatives in Congress who don’t want to fund the recently passed Food Safety Modernization Act.
- CDER to Hold Webinar on the “Bad Ad” Program – I have always thought this program odious, to say the least. But CDER is still pushing it and to that end they are holding a Webinar on April 28 and 12 noon.
That’s it for me this week. Have a good weekend and if you haven’t done your taxes yet, get cracking.