Weekly Roundup 4/24/09

J0149000 I have not had a case of blog-fade, I am merely incredibly busy of late, which has made posting a challenge.  Many mornings lately have involved 4:30 AM wakeups.  You know how it is.  There is comfort in unusually beautiful weather here in Washington, D.C. with lots and lots of blossoms in gardens not my own.  My neighbor's wysteria, for example, is running amok in purple, while mine is merely evergreen.  And a lot has happend this week, and here is just a bit of what I thought interesting:

  • The Morning After the Morning After – This week there was an announcement from the FDA that recalls one of the most credibility-busting episodes from the past eight years involving the agency putting politics over principles.   The FDA issued the following nearly Twitter-sized statement yesterday:  On March 29, 2009, a federal court issued an order directing the FDA, withiin 30 days, to permit the Plan B dtug sponsor to permit Plan B available to women 17 and older without a prescription.  The government will not appeal this decision.  In accordance with the court's order, and consistent with the scientific findings made in 2005 by the Centers for Drug Research and Evaluation, FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B to women 17 years of age and older.   Plan B is manufactured by Duramed Research, Inc. of Bala Cynwyd, Pa.  The more interesting parts are what the judge had to say.  
  • Swine Flu Outbreak is Fast and Furious – Concerns about a U.S. flu outbreak in the Southwest of Swine flu have been fanned by news that the outbreak is even greater in Mexico, reportedly causing several deaths.  The BBC and others report that the virus appears to be a virus not previously characterized in human beings.  The World Health Organization reports that 5 cases were reported in California and 2 in Texas, but that there is a potential that it has caused many more deaths in Mexico.  
  • Device Division at FDA Under Scrutiny – The New York Times reported this week that the FDA held a rare internal meeting to consider strategic matters related to criticism leveled at the agency about the way that it approves devices.   It is one more indication of the serious credibility issues facing the agency and the fact that resolution of those issues, piled up for so many years on so many fronts, is not going to soon go away.

  Have a beautiful weekend everyone.


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