Weekly Roundup 9-23-11

Very tardy this week with the Weekly Roundup – it has been a very busy week on my end with lots of running around. So please forgive the liberty of being a bit behind…

As if taking a cue from politics, the weather in Washington has been persistent gloom with intermittent periods of rain, humidity and an overall lack of cheerful sunshine.  One finds one’s self looking forward to February….

In the meantime, here is a bit of what happened that appeared noteworthy this week:

  • Judge Raises Questions on FDA Proposed Ciggy Packs – Last June the FDA unveiled its new proposed packaging for cigarettes that portray graphic images meant to discourage smoking.  Tobacco companies have brought suit and in a court room in San Francisco this week, the San Francisco Chronicle reported that a judge had some hard questions about the packaging.  Do the graphic images go beyond warning to advocacy?  The article reports the court may issue a ruling in October.
  • FDA Approves Remicade for Kids Over Six – Janssen Biotech’s Remicade (infliximab) was approved by the agency this week to treat ulcerative colitis in children older than six years old.  ”With the approval of Remicade, children with moderately to severely  active  ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option,” said Donna Griebel, M.D., director Volume Pills of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “However, there are serious risks associated with its use. Patients and their families should always discuss with their physician the risks and benefits of using a medication before deciding to start treatment.”
  • Listeria Outbreak in Multiple States Traced Back – While many in Congress believe that further funding for food safety is unnecessary, an outbreak of Listeria has spread to multiple states.  The outbreak has been traced back to cantaloupes grown at a particular facility in Colorado.  The FDA says that the CDC has confirmed that there have  been 4 deaths and that at least 10 states have seen cases.
  • Guidance on Biosimilars Coming Soon? For those who have been waiting for nearly 10 months for FDA’s DDMAC to come out with the social media guidance that the agency said would likely be available by the end of 2010, there may be a grain of salt involved in the speculation circulating that the FDA will be producing its draft guideline on the regulation of biosimilars.  A Reuters report quotes one source as saying it may be a “matter of days”.

That’s it for me this week folks.  I’m afraid the coming week also looks to be quite busy, but I’ll do my best to keep up.

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