The nation has been served up a whole dish of bad theater from Washington this week. The play is bad. The actors are bad. And at least one of the leads can’t keep his chorus in line, however, if the role calls for weeping, then there will be no problem. Worst of all, there seems to be no script. One wonders if we could not just have a Congressional shut down and let the government keep going?
The Food and Drug Administration uttered no guidance as of this writing on the impact of a government shutdown on the agency. The Federal Trade Commission was more transparent and user friendly however, and issued a statement about how the shutdown would affect that agency. Well, one thing we know for sure. A government shut down will mean a delay in the issuance of a draft guidance by FDA’s DDMAC on social media and the Internet, right?
In the meantime, here is a bit of what else happened in our corner of the world:
- FDA Approves New Thyroid Cancer Treatment – The agency this week approved vandetanib to treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. According to the FDA release, there are approximately 44,600 new thyroid cancer cases were diagnosed in the United States during 2010, and about 1,690 people died from the disease, according to the National Cancer Institute. Medullary thyroid cancer is estimated to represent 3 to 5 percent of all thyroid cancer; its estimated incidence in the United States for 2010 is about 1,300 to 2,200 patients, making it one of the rarer forms of thyroid cancer. The drug is called vandetanib is marketed by AstraZeneca. The release further stated that there is no trade name established for this drug at this time. I found that curious as I was under the impression that the trade name was part of a drug’s labeling and was always agreed upon before approval. I guess I was wrong!
- FDA Approves New Device to Treat Brain Aneurysms – Another approval from this week – the agency approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery. To implant the device, the Pipeline is attached to the end of a catheter, which is inserted into an artery in the leg. The catheter is threaded into the carotid artery and into position at the aneurysm where the Pipeline is expanded against the walls of the artery and across the neck of the aneurysm, cutting off blood flow to the aneurysm. The blood remaining in the blocked-off aneurysm forms a clot which reduces the likelihood the aneurysm will grow bigger or rupture. Aneurysms successfully treated with the Pipeline will often shrink over time. According to FDA, the Pipeline should not be used in patients with an active infection or patients who cannot take antiplatelet therapy (medication that interferes with blood clotting), such as aspirin. Patients should receive adequate antiplatelet therapy prior to surgery to place the Pipeline. The Pipeline device should not be used to treat an aneurysm with a stent previously placed across its neck. The Pipeline Embolization Device is manufactured by ev3 of Menlo Park, California.
- New Twitter List of Healthcare Beat Reporters – I created a new list on the EyeonFDA Twitter feed that contains the feeds only of top tier healthcare beat reporters, including Adam Feuerstein, Matt Herper, Susan Heavey, Lisa Richwine, Rita Rubin and many more. If you want to check out just what these reporters are tweeting about without having to sift through other tweets about a myriad of subjects, you might want to check it out.
- FDA Begins Unveiling Aspects of Food Safety Modernization Act – There has been a lack of clarity about the parts of the Food Safety Modernization Act (FSMA) will get put into place if there are no appropriations to support it. Nevertheless, the FDA this week posted three videos to their YouTube Channel that outline various aspects of the law. Here are links to the videos – one on Preventive Controls; one on Compliance; and one on Imports.
That’s it for me this week folks. Have a good weekend, with or without a running government.
