Weekly Roundup – 01/12/07

J0407411My apologies for the lack of postings this week.  The new year has gotten off to a quite busy start and I was on the road, but unable to access Typepad so that I could post.  I hope to make up for my lapse in the coming days!  Meanwhile, it was not only busy for me, but lots of others too as there have been many developments:

  • The 100 Hours and Medicare Part D – True to their word, Democrats moved quickly during the "100 Hours" – an effort on the part of Democrats to recreate the public relations impact of the Republican "Contract with America" when they took over the congress – and managed passage with a vote of 255-170 in the House of H.R. 4, a measure that would allow the government negotiating power on prices paid by Medicare for Part D drug coverage, which the President has stated he will veto.  If you want to see how people voted, go to this nifty page by GovTrack.  Remember, you can track legislation using GovTrack by clicking the link in the right column. 
  • FDA Proposes A Ban on Some Types of Cattle Feed – Coincidentally, I am right now reading a book called The Family That Couldn’t Sleep by D.T. Max (which I highly recommend) that delves into the history of research of prion related diseases.  This week, the FDA is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy or BSE.  The proposed rule would cover drugs (prescription, over-the-counter, and homeopathic), biologics (such as vaccines) and medical devices intended for use in humans as well as drugs intended for use in ruminant animals like cattle and sheep.
  • FDA Proposes New PDUFA Funding Levels – As noted here earlier, the FDA is seeking to add new funding to the coffers from PDUFA fees for the purpose of increasing the ability of the agency to review of television drug advertising.  If accepted,  that annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current base line.
  • Viagra without a Prescription?  – According to reports, there is consideration being given to taking the first erectile dysfunction treatment to Over-the-Counter status.  Having worked a great deal on issues related to OTC conversions, I can say that the challenges faced by such a switch are considerable.  The inherent requisites for a switch – that a patient can self diagnose and use the product safely without the intervention of a physician – and the fact that an emergency birth control is now available OTC, will create grounds for an interesting debate on the topic. 

That’s it for this week.  It is a holiday weekend and there will be no posting on Monday.  Have a good weekend. 

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