Transcript of How Regulatory Science Benefits Patients

[ON SCREEN TEXT] How Regulatory Science Benefits Patients with Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER)

JANET WOODCOCK: To better understand the role that regulatory science plays in drug development and drug regulation, I think it's useful to look at an example. An example I'd like to use is called "open flow microperfusion."

Now, for a long time, we've had trouble with topical generic drugs, figuring out whether they were bioequivalent to the brand drug—to the reference drug. And why is this? It's because not enough is absorbed into the body to measure blood concentrations and determine their equivalent, and that's what we do with oral drugs.

So CDER, with other international researchers, has worked on, pioneered, and developed a technique called open flow microperfusion. The details involve inserting little tubes under the skin—into the skin—and being able to figure out how much drug is absorbed through that layer of skin by testing. This has been tested and validated by CDER, and we think it is very promising as a technique to use in the future for bioequivalence of topical therapies.

What does this mean? Big picture? It means perhaps that applicants won't have to do clinical trials that compare the generic drug to the reference drug to get onto the market. They may be able to use this microperfusion technique, which is straightforward, simple, and would give us the answer in a much shorter amount of time.