Wednesday, June 29, 2005

HELP WANTED: Director of Drug Safety

The FDA Office of Drug Safety has a HELP WANTED sign in its window:

New Leadership for Safer Drugs

The Office of Drug Safety announced a nationwide search for a new director of drug safety (DDS) with the Food and Drug Administration.

[Acting FDA Commish Lester Crawford was heard commenting: "A director of drug safety has got to be found somewhere. Any DDS's under the desk? Nope, no DDS's there!"]
The DDS will be in the center of a whirlwind of special interests with huge financial stakes at risk in the safe and appropriate use of medications. These interests will make mincemeat out of this grade 15 federal bureaucrat with a salary somewhat higher than an average drug rep and whose impact on the future of public health is dubious at best.

The DDS office, a fortified subterranean bunker, is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in Rockville, Maryland.

Duties of the position include:
  • leadership of the agency's drug post-marketing risk assessment operations. In this capacity you will be supervising about 2.5 FTEs.
  • working closely with stakeholders inside and outside the Federal government. You'll hobnob with the likes of Billy Tauzin, president of PhRMA. He's pretty familiar with Washington and will introduce you to all the right people. You will also work with the Drug Safety Oversight Board. But don't worry, the vast majority of Board members are fellow bureaucrats form the FDA. There won't be any citizen representatives on the Board to give you a hard time. Oh yes, you'll also work with members of Congress who are really are a pain in the butt, but what can we do?
  • developing and maintaining international and national contacts with regulators. The UK regulators are really a fun group although they have a tendency to upstage the US and withdraw dangerous drugs at the drop of a pin, if you know what I mean.
  • implementing policies and initiatives related to adverse drug events and the Medwatch program. You are not to touch this voluntary system and try to make it more effective in any way! We don't care that HHS Secretary Mike Leavitt suggested using the emerging technology of the National Health Information Exchange to track drug adverse events (see article "HHS: Drug safety reporting system could be prototype for health data exchange" and his speech at a recent Health Information and Management Systems Society Conference). A knowledge of computers and the Internet is NOT a pre-requisite for this job.
  • representing FDA and CDER in scientific and regulatory matters related to drug safety. Yeah, you'll be the guy sitting on the hot seat before congressional committees like that pesky Health, Education, Labor, and Pensions Committee.

"The position requires a medical doctor..."
[I think they mean the candidate has to be a medical doctor, not that the DDS will need a doctor after being on the job for a day or two; a Doctor of Osteopathy is also OK, even from a school in Canada where all those dangerous drugs are being imported from, although I hear the Canadians will soon put a stop to that nonsense! (See "Canada to ban bulk drug sales to U.S."). If so, and if the drug industry is right about the danger of importing drugs from Canada, your job should be much easier and you will hardly need to work at all for the "103,947.00 - 180,100.00 USD per year" that the FDA will pay you.]
Just to be on the safe side and satisfy our legal department, you will also need advanced knowledge of epidemiology, public health issues related to drug safety, and risk management.

FDA officials worked with the US Office of Personnel Management on a rigorous job analysis and to develop the selection process for this high-profile position.

Those interested can find more details and an
online application at the USAJobs Web site.

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