So what does your office do?
The Office of New Drugs is probably best known for
the work we do on deciding what drugs get approved
for marketing in the United States, so that's
the work that most people are aware of.
Awesome responsibility.
It is a very big responsibility, one that
we take very seriously, obviously.
We have other responsibilities as well,
related to overseeing all the clinical
investigations of new drugs,
meaning the studies in humans.
We make sure that those studies are safe for the
participants and that the studies are accomplishing
effective outcomes so that they're useful in the drug
development program.
We're also responsible for monitoring drugs after
they've been approved for new information that may
become available about new uses or safety concerns
that need to be addressed.
I think that's a pretty important part of this
because once the FDA approves a new drug, the
investigation continues.
The monitoring continues.
It's very important for people to understand that
we don't know everything about new drugs at the
time we approve them.
That's kind of built into the system because if we
waited until we knew everything you could
possibly know, then the wait would be too long,
and patients would be denied access to important
new treatments.
So, there's always a balance that has to be
made between how much certainty you have about
the drug at the time of approval and how much
uncertainty; what you don't know and that's why
we have to have a very active program after
approval to look for new information.
How long have you been doing this?
I've been at FDA almost 18 years now.
I've been the director of the Office of New Drugs
for eight years.
How have you seen things change?
I think there's much more of an expectation for FDA
to be more actively involved in how the drugs
are used after we approve them.
When I came to the agency in 1992, the agency was
expected to do our work before approval and make
those decisions about what drugs went into the
marketplace and then the rest was left essentially
to the practice of medicine.
And I think over time, as things have gotten more
complex, health care has evolved, and there have
been some safety concerns about the growing use of
drugs, the expectations are that we will play a
much more active role in communicating what we know
about drugs to the prescriber, to the doctor
and the patient so that they can make
well-informed decisions on how to use those drugs
most appropriately.
So you've talked about what it used to be like
and what it's like now.
How do you envision the future?
I think there's going to be continuing expectation
that we play a more active role in helping the health
care system to most effectively and safely
utilize drugs.
And we have several initiatives underway where
we're trying to leverage the information we know
and the expertise we have in house and work with
partners outside the agency to have that
actually show up and have an impact on public health
outcomes -- outcomes for individual patients but
also public health in general.
And that's why those of us who work here, work here,
because we want to have an impact on patients and
public health.
And some of those initiatives are?
Well, there's one called the Safe Use Campaign,
which we rolled out a few months ago, which is
really intended to do exactly what I said.
It's to leverage our resources and the
resources of other stakeholders such as
professional groups like doctor groups, patient
stakeholder groups and others to get the message
out and multiply the message and make it real.
For so long, FDA communicated to the public
about how to use drugs through the labeling.
And the labeling, while it's a very important
scientific, technical document, it's not a very
good communication vehicle.
So we need to work to find better ways with the
prescribers, with the patients, with the
pharmacists to get the information out in a
useable form.
And in today's environment, with the
explosion of electronic systems and medical record
systems that are electronic, it opens up
whole new avenues that we never had to explore
before.
Safe uses, the goal there is to cut down on what?
Number one is to improve the decision making about
the use of drugs in individual patients.
Because at the end of the day, a doctor and patient
have to make an informed decision about what drug
is right for them and what are the consequences or
risks associated with that drug.
It's also intended to, from a population basis,
decrease on the adverse consequences of either
inappropriate use of a drug or just making people
aware of risk of drugs.
And from your position and also the position of a
patient and the health care provider, you never
have all of the information that you would
like to have to make that risk based decision, which
you just do the best you can.
Well, we do the best we can.
We have standards for how much information we
require before a drug is approved.
And those are pretty high standards.
We're viewed as the gold standard for the world, I
think, by most people, our drug approval decisions
and how we go about doing our work.
But it's important that we transfer and work with the
healthcare system to transfer that knowledge
into effective use of those drugs, safe use of
those drugs.
Doctors are very busy.
They're expected to see a lot of patients in a short
amount of time.
There's been an explosion of new drugs available
over the past couple of decades, so there's a lot
to keep up with.
So I think we need to leverage new systems to
help doctors to have that information so they can
make those well informed decisions.
So you've been on the front lines of the whole
debate or the whole discussion, about drugs
are not approved fast enough and on the other
side, drugs are approved too quickly.
Right, right.
We usually get those complaints
at the same time.
The reality is, we don't make systematic decisions
that we're going to speed up or slow down our
decision making on drugs.
We look at each application for marketing
the drug on its own merits and independent of any
perceived FDA is speeding up, FDA is slowing down.
You go where the science leads?
The science gives you the information, but the
science doesn't always give you the answers.
At the end of the day, we have to make judgment
calls about whether we think on a population
basis; the drugs' benefits outweigh its risks.
But people need to understand we're making
that on a population basis of the people who are
expected to use the drug for the use that we're
approving it for.
That needs to then be translated into the
individual patient by a doctor and a patient,
making a well informed decision.
Because what we may decide on a population level
makes sense, that the benefits exceed the risks,
for an individual patient, the benefits don't exceed
the risks in certain cases, and those are the
decisions that need to be made.
Thank you.