FDA Press Releases – What They Say

Keeping my eye on FDA, and being most interested in communications, AND having a penchant for looking at patterns through databases, I started categorizing FDA press releases to see what they talked about and in what way.  I only started as of January 1, 2013 and tracked them by category.  What was the subject matter – an approval? A legal action? Rule making? Then I looked at what sector was affected – Drug, Device, Food/Beverage?  Some of the releases are in Spanish, so we tracked that too. Lastly we tracked the product area/use/indication affected and the product name, if there was one involved. In this way, I can look solely at approvals, or approvals in a particular treatment area.

A little of what i found. I counted 165 press releases for 2013 with 49 of them being co-produced in Spanish. What you find in many respects is what you might expect – the largest category was related to approvals. But there are some unexpected things as well – the second largest category was about FDA enforcement actions. About half of all press releases were about product approvals, which one might expect. However, the number of bilingual releases varies considerably by category. In the end, while each press release is important, it is also good to get perspective about the body of communications issued by the agency. A piece of pie is great, but one should appreciate the whole as well.

And here is a breakout as the releases affected different sectors:

Approvals (81)

  • 61 Drug Approvals
  • 19 Device Approvals
  • 1 Tobacco-related Approval
  • 26 of these were also produced in Spanish

Alerts (9)

  • 6 Regarding Drugs
  • 2 Regarding Food and Beverage
  • 1 Device
  • 3 of these were also produced in Spanish

Legal Actions (26)

  • 10 related to Drugs
  • 10 related to Food and Beverage
  • 5 related to a Supplement
  • 1 realted to Devices
  • 3 of these were also produced in Spanish

Recalls (12)

  • 10 Drug recalls
  • 1 Device recall
  • 1 Pet food recall
  • 1 of these was also produced in Spanish

Rule Making (23)

  • 7 related to Drugs
  • 7 related to Devices
  • 7 related to Food/Beverage
  • 1 related to Soap
  • 1 related to Tobacco
  • 12 of these were also produced in Spanish

Grant Making (3)

  • 1 related to Drugs
  • 2 related to Devices
  • None of these were also produced in Spanish

The balance fell into a category I called General Announcements which was a collecting place for miscellaneous releases.

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