Weekly Roundup 5-3-13

The grass is not greener on my side, mainly because it is mostly not there.  The lawn, if you want to call it that, looks like it needs a lot of attention – probably more than I have to give it.  Still, that did not stop me from mowing what was there this week for the first time this season as the old mower really did (miraculously) start up for another year.  I am happy to say that many weeds met their end, pulled out by the root after a good, soaking rain….

It was a busy week on many friends, particularly for those of us with our eye on FDA. Here are a few of the things that I wanted to bring to your attention in case it got by you:

  • FDA Approves Plan B for Wider Age Range OTC – This was certainly one of the more interesting developments that transpired this week and a lot happened here. First, prior to this week, a court ordered that age restrictions for access to OTC Plan B contraceptive be removed.  Then – this week, FDA announced it was approving Plan B for use by women without a prescription if they were age 15 years or older.  Then, it was reported that the Justice Department announced that it would be appealing that court decision.  This has been a long, long saga. Obviously, it will get longer.
  • EMA Opens up Public Comment Period for Guideline on Biosimilars – This week EMA posted their Guideline on Similar Biological Medical Products on line to invite public comment.  The comment period opened May 2 and will run until October 31.
  • FDA Approves Procysbi for Rare Genetic Condition – Procysbi (cysteamine bitartrate), marketed by Raptor Pharmaceuticals, was approved this week by FDA for the treatment of nephropathic cystinosis in children and adults.  This is a rare genetic condition that only affects an estimated 500 patients in the U.S. and 3000 worldwide which causes a protein building block (cystine) to build up in every cell of the body which in turn, causes kidney problems and lead to small growth and stature, among other things.
  • FDA Investigating Added Caffeine – The agency announced this week that in the face of a growing trend where caffeine is being added to a wider span of food and beverage products there will be a higher level of scrutiny on the part of FDA. Caffeine was approved nearly 60 years ago for use in the manufacturing of cola beverages, but the agency says that existing rules never anticipated the current proliferation of products.  The Q&A supplied by FDA however did not provide much detail into the process the agency will be using to conduct its investigation into existing caffeine in products and what to do about it.

Speaking of caffeine, I think I’m going to take a break here.  I hope you all have a wonderful weekend and are enjoying Spring.

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