TH E   N I H    C A T A L Y S T     S E P T E M B E R  –  O C T O B E R   2008


Demystifying the FDA with Two- to Six-week On-site Rotations

Christopher Wanjek

To many an outsider, the Food and Drug Administration comes across as a regulatory octopus responsible for the safety of billions of dollars worth of consumer goods, from most food items, to drugs and medical devices, to cosmetics and even animal feed. The FDA estimates that it oversees items accounting for 25 cents of every dollar spent by consumers.

And somewhere within this fantastic machinery—amongst green onion recalls and approval of the latest LASIK technique—lies your future, an Investigational New Drug (IND) application, the culmination of years of basic research you want to take to the bedside. Understanding the FDA could substantially increase your odds of trouble-free application process.

The FDA, of course, is our partner in a common mission to improve the health of all Americans. To this end, the NIH and FDA have teamed up to offer short-term rotations at the Center for Drug Evaluation and Research (CDER) that include tutorials on how to prepare for an IND and on therapeutic area-specific drug-development guidelines. The rotation spins both ways, with FDA scientists spending time at the NIH to understand how we work.

The new program, over two years in the making, was spearheaded by Juan Lertora, director of the Clinical Pharmacology Program at the NIH Clinical Center. The program is open to all scientists and is perfect for trainees and junior investigators, Lertora said. NIH participants would benefit from access to various closed-door meetings and the chance to see and participate in reviews of preclinical and clinical data on investigational drugs. Participants would make valuable contacts at the FDA, as well. The program is flexible but advanced planning is required; the rotation can start anytime and last for about two to six weeks.

Four FDA scientists have completed a rotation with clinical research teams at NCI and NIAID, but so far only one NIH scientist has gone to the FDA. Although the program officially started in 2007, it was not until this year that the FDA could work through its own administrative roadblocks to allow outsiders such unprecedented access. NIH scientists need to sign a confidentiality agreement, for example.

"We finally got the green light this year," said Lertora, who hopes the program will take off as more scientists learn about it. "Now there is a mechanism."

Lertora is the point of contact for NIH scientists interested in the program, and he can be reached at The rotations take place in CDER's Office of Clinical Pharmacology, led by Larry Lesko. Lertora requests that those interested should obtain approval from their fellowship Program Director at the Clinical Center and contemplate a therapeutic area of interest and proposed timeframe for the FDA rotation. Lertora would then help identify mentors at the FDA.


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This page last updated on October 1, 2008, by Christopher Wanjek