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    Urologist, former regulator shares FDA insights

    Philip M. Hanno, MD, MPH Daniel Shames, MD

    Urologist Daniel Shames, MD, has had a unique and varied career, with stops in clinical practice, the FDA, and his current role as a consultant to the pharmaceutical industry. Dr. Shames’ wide-ranging experience brings an insightful perspective on the topics he discusses in this interview: what goes into FDA drug approvals, quality of life endpoints, and the Sunshine Act. The interview was conducted by Urology Times Editorial Consultant Philip M. Hanno, MD, MPH, professor of urology at the University of Pennsylvania, Philadelphia.

    Please give a brief overview of the various roles you’ve had throughout your career.

    After I finished my residency at the University of Pennsylvania, I entered service in the Army and then set up a clinical practice in Columbia, South Carolina, working with two other urologists. I did that for about 18 to 20 years and then decided I wanted to get out of clinical medicine and move back to the Northeast.

    I applied for non-clinical positions and got a job at the FDA in 1996. My career at the FDA lasted 12 years. Six of these were spent as the director of the FDA’s Division of Reproductive and Urologic Products. Eventually, if you reach a certain level at the FDA, you are sought after as a consultant to the pharmaceutical industry or recruited to work for a pharmaceutical company. I left the FDA in 2008 to set up a consulting practice, where I currently work with most of the top 25 bio pharma companies as well as medium and start-up firms, helping them with clinical trial design and interactions with the FDA. Additionally, I perform due diligence for investors seeking to purchase a drug company or a particular drug, and consult with law firms regarding litigation that involves FDA drug issues. (Also see, “For this urologist, three careers have been gratifying")


    You were far ahead of the curve as a medical officer in the FDA when you championed the use of quality of life indices and subjective results as primary and secondary outcomes in pharmaceutical trials. How did you engineer this change, and do you think this has turned out to be a good thing?

    I think it became obvious to me that these changes needed to happen. This was a time when we were receiving a lot of submissions related to sexual dysfunction—both male and female—incontinence, and menopausal symptoms (the division regulated both urologic and gynecologic drugs), among others. We also had to deal with conditions such as interstitial cystitis and nocturia. For these conditions, merely counting episodes of intercourse, incontinence, or hot flushes etc. may not wholly support the benefit of a drug. In order to support the benefit of drugs of this type, one needs to know what the patient perceives as a clinical benefit. That’s how it became natural to me that we needed to become more active in terms of patient-reported quality of life.

    At the same time, there was a movement in the FDA to go in that direction. I became part of the Patient-Reported Outcome (PRO) Committee, and ultimately guidance was developed on how to do these things. It’s become more important. At the time, we did have some meetings with the industry regarding these issues to get them stimulated in that direction.


    Philip M. Hanno, MD, MPH
    Philip M. Hanno, a Urology Times editorial consultant, is professor of urology at the University of Pennsylvania, Philadelphia.


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