Princeton university is having a problem with meningitis B.
They wanted to use a vaccine to help stop the spread. The one they found is not licensed for use in the United States yet but is licensed in Canada and Europe.
Princeton asked our licensing agency, the Food and Drug Administration for permission to use the foreign vaccine. The FDA gave permission.
What does that say about our licensing procedure?
We deserve better
Brutus
Maybe it says more about the way big pharm companies go about licensing drugs in various companies. Did they seek approval of the drug in the US? If not, how can the government approve a drug that has not been submitted? Here is info from the CDC website:
“Novartis, the company that makes the serogroup B meningococcal vaccine, has completed phase II clinical studies in the United States. After careful review of requirements for licensure, existing vaccination schedules, and feedback from public health experts, the company has decided to advance a meningococcal vaccine that helps protect against five serogroups (A, B, C, Y, and W) into late stage development. Such a vaccine would cover the most common serogroups that cause meningococcal disease circulating in the United States. The exact timeline for approval in the United States depends on many factors. The serogroup B meningococcal vaccine is approved in Europe, Canada, and Australia. Approvals in additional countries are expected soon. Questions regarding Novartis’ plans to seek licensure in the United States should be directed to them.”
link: http://www.cdc.gov/meningococcal/vaccine-serogroupB.html#vaccine-approval
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That should read “…various countries…” not companies…
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The need for the many outweighs the “red tape” need by a Big Government…..
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