Wednesday, July 02, 2008

FDA Intern vs. Inebriated Advisory Committee Antagonist

Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even FDA commish Andy von Eschenbach!

FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!


For the "Fans of Emily, PhRMA Intern" who have missed her adventures, I am pleased to announce that she has moved over to take on the job of FDA Intern, which is a switch from the usual career development path from public service to private sector. But, Emily is just an Intern and is wise to learn the ways of FDA. Besides, PhRMA gave her the boot and FDA lately has been desperate to fill vacancies.

No sooner was FDA Intern ensconced in her diminutive, windowless office than she came upon an article published in The RPM Report about new security measures being imposed at public advisory committee meetings.

"If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic," said an FDA spokesperson, "we may have additional security procedures."

As reported in The RPM Report, those procedures include:

  1. Creating a physical barrier by roping off the committee from the public. The intent, [FDA spokesperson] said, is "to put some separation between those who might become agitated in the audience and committee members." (For taxpayers, it carries another benefit—preventing the public from sneaking pastries off the committee’s breakfast tray.)
  2. Increasing the presence of security guards in the committee room—both in uniform and street clothes.
  3. Reading a statement at the start of the meeting about "good rules of behavior."
Immediately thinking that her services were needed, mild-manner Emily Jameson quickly assumes her alto ego -- FDA Intern!

Minutes later, traveling faster than an FDA warning letter to a drug company CEO, FDA Intern arrives at the advisory meeting in progress at an adjacent building. Bursting through the door, she immediately confronts Joe public asking embarrassing questions.

Yes, FDA Intern foils another attempt at disrupting the lawful activities of the FDA in carrying out its duty to efficiently approve drugs for marketing.

We will assuredly report in this forum the further adventures of FDA Intern as she tackles even more evil and insidious enemies of FDA who are also after the doughnuts and refuse to stand behind the ropes!

Meanwhile, if you hear of any of FDA Intern's exploits that should be reported on here, please contact this reporter at johnmack@virsci.com.

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