Tuesday Newswire: An FDA Smorgasbord

[This article posted on January 13, 2009. It is posted within the following categories: Pharma & Devices, via Michael Douglas, MD, MBA.]
  • Apparently not much is being done to to force fiduciary relationships between pharma companies and the physicians who study and test devices on their patients as subjects. A report [PDF] commissioned by the HHS Dept. confirms the findings.
  • FT Editorial: Time for a stronger FDA.
  • A parting gift of sorts for Pharma from the outgoing Bush administration? Congressional Democrats decry the FDA guidelines which will allow pharma companies to advise physicians on off-label uses of medications described in the medical literature. Since these guidelines do not represent FDA-approved indications for the drugs, Democrats are calling foul, implying a carte blanche atmosphere for ultimate sanctioned widespread utilization of treatments not appropriately studied and vetted normally.
  • Citing “computer failures”, Indiana-based Wellpoint (the nation’s largest insurer via revenue) tries to explain why it has cut off prescription drug access to its elderly beneficiaries.
  • The FDA has asked pharma company Merck for additional information before approving the HPV vaccine for use in older women.

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