Weekly Roundup – 12-9-11

The last of the leaves are being picked up.  The trees are nearly bare.  The Thanksgiving leftovers are long gone and there are the cards to address and send and the shopping to be done and the next set of diet busting menus to plan.  And even though winter has not started yet, many of us are ready to see it end.

In the meantime, here is a bit of what happened this week in our corner of the world:

  • FDA to Propose User Fee Structure for Biosimilars - This week the FDA served notice of a public meeting to discuss recommendations for a user fee program for biosimilars, which were also published in the Federal Register notice of the meeting.  The meeting will be held at the FDA White Oak campus on Friday, December 16 at 9 am and registration is supposed to occur by the 14th.  This meeting is occurring after a period of consultation with the public on a range of matters related to the structure of the program.
  • Seizure of Dietary Supplements Containing Banned EphedrineIn 2004, the FDA issued a regulation banning ephedrine from dietary supplements.  However this week the agency announced a seizure of imported material by U.S. Marshals at the request of the agency of supplements from a California facility.  The release noted that the ephedrine was discovered in raw material that contained the substance despite the fact that it was on the label.
  • FDA Revises REMS on Two Drugs - The agency announced this week that HGH the risk strategy programs (REMS) for two treatments for low platelet counts – Nplate and Promacta – were eased by the agency this week.  Prior healthcare professionals associated with the prescribing and dispensing of the drugs as well as patients receiving the drugs had to enroll in education programs.
  • FDA and FTC Seek Removal of HCG Weight Loss Products – Seven companies received Warning Letters this week for marketing over-the-counter human chorionic gonadotropin (HCG)  products labels “homeopathic” for the purpose of weight loss.  HCG is an FDA approved prescription product.  For this product, consumers were instructed to take the product with a very low calorie diet.  The agencies warned the companies that they were selling drugs that have not been approved and for making unsupported claims regarding their use.  It was also an example of the agency using a multi-media release, which contained two videos.
  • FDA’s Approach for Artificial Pancreas – This is news from last week when there was no Weekly Roundup, but covers an important issue and so is included this week.  On December 1, the agency announced that it was issuing a draft guidance that would facilitate development of an artificial pancreas device to treat diabetes type 1.  The agency said the guidance provided flexibility and a streamlined process for design and testing the device – which is actually a combination of two medical devices – an insulin pump and a continuous glucose monitor.

That’s it for me this week.  I hope you all have a wonderful weekend.

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