[MUSIC] [JANET WOODCOCK, MD]
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. So that’s an example of how regulatory
science could really streamline drug development, improve the field, and
improve access for patients. So overall, regulatory science involves efforts
to better understand how to evaluate the performance of medicines, make sure they’re safe
and effective and of high quality, and really deliver on our promise to Americans that
they’ll have access to high-quality, affordable, and safe and effective drugs. [MUSIC]

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