Robert R. Fenichel

Professional Activities

FDA-related

Working at FDA from 1988 to 2000 was formative for me.  Some FDA-related material is here.

Consulting

  From the time I left FDA (mid-2000) through 2016 or so, I made my living as a consultant.  A few of my clients were academic institutions, a few were lawyers suing or defending pharmaceutical companies, but most were pharmaceutical or medical-device companies who wanted help in dealing with the FDA.  A few clients were based in Canada, a few more in Europe, and all the rest were based in the United States.

My unvarying approach was to say that the FDA was interested in good science, exemplified in well-designed and candidly-interpreted randomized trials.  Companies approaching the FDA with this awareness could enter as colleagues, not adversaries.

My consulting activity had dwindled as I aged, and I became uncomfortable whenever I visited Donald Trump's USA.  I considered myself to be semi-retired, but I was still willing to undertake the occasional interesting project.  My threshold was high: too many projects began well ("Tell us what you think we should do"), but then degenerated ("Tell us what you think we can get away with").

Now (2025) the FDA and the Department of Health & Human Services have been turned over to quacks and charlatans.  I don't know how to give advice to anyone trying to deal with them.

Medical topics

At one time, much of my consulting had to do with drug-induced changes in ventricular repolarization.  That topic is described here.

I used to think that having too many events in a RCT was like being too rich or too thin, but it isn't.

Describing Patients

Starting in 2002, I was a volunteer mentor for second-year Georgetown Medical School students during their first experiences of interviewing and examining hospitalized patients.  The students wrote up their findings, I annotated their reports, and we discussed the issues that arose.  Some of the same problems occurred from year to year, and I started assembling my old annotations into handouts.  Georgetown Medical School did not make things easy for an irregular faculty member like me, and I stopped working with their students in 2004.  The last version of the collected handouts is here.

 curriculum vitae

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Page revised: 10/03/2025 12:04