Weekly Roundup

J0399271A New and Regular Feature – I’ve decided to use Friday’s as a time to round up the small news, stuff you might not have been able to notice, or if you did, to think about much. 

  • New Appointment at FDA for CDER – The FDA issued a press release announcing an appointment in a newly created position.  The person is Dr. Paul Seligman.  The position is – get this title – the Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research (CDER).  Hope they give him a big card.  In the press release, Dr. Galson, Director of CDER, stated that "The appointment of Dr. Seligman represents our efforts to consolidate responsibility for developing Center-wide drug safety policy as well as coordinating our efforts in the area of risk communication.  We anticipate that his step will help provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the healthcare community and the public."  I hope that isn’t his job description.  That said, the press release offered no insight as to what Dr. Seligman will actually do or how the industry can work with him on issues related to drug safety.  Stay tuned. 
  • Bloody Bad Guys Nabbed – On a more interesting note, the FDA announced convictions in an illegal blood diversion scheme.  According to the FDA press release, the bad guys were involved in illegal activities of various natures that bought and sold illegally obtained blood derivative products to the tune of defrauding Medicaid and Medicare programs of more than $45,000,000.  Physicians received kickbacks for writing fake prescriptions that were then reimbursed and resold.  It may not be the stuff that crime shows are made of, but represents good work on the part of the Office of Criminal Investigations by the FDA. 
  • Hot Topics Page Created – on the Bausch and Lomb contact lens situation.  For the latest, click here
  • Annual Generic Drug Forum Speech – If you are interested in the weedy details of FDA approval of generics, Dr. Gottlieb gave a speech on it at the Annual Generic Drug Forum  on April 7 that was just posted this week.  Make sure you have coffee. 
  • FDA Sends Approvable Letter to GSK for OTC XenicalReportedly the letter does not demand new studies. 
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