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David A. Kessler, M.D. - HIMA

Remarks by
David A. Kessler, M.D.
Commissioner of Food and Drugs

HIMA
March 29, 1993
West Palm Beach, Florida

Good afternoon.

I'm here today to talk about some important matters that
will occupy all of us in the coming months and years.

Events of the last couple of years have made it absolutely
clear that we must strengthen our medical device program.

I know some of you see that statement as a red flag. But
let's remember that the industry and FDA share some common goals.
And I believe that the effort to strengthen our program can build
on those shared interests.

The fact is that both the industry and the FDA want the
medical devices that reach the American people to be safe and
effective. That's in everybody's interest.

And both the industry and the FDA recognize the importance
of getting new technologies out to American consumers as quickly
as possible--especially when the device represents a major
breakthrough in patient care.

Doing those things right is what strengthening our device
program is all about.

What you as representatives of regulated industry and we at
FDA must do, is roll up our sleeves and get on with that task.

I know that a lot is at stake for you in this process. I
hear your concerns.

I appreciate your concern about review times. You are a
relatively young industry. For many of you, the time it takes to
review an application can literally make or break you.

I also hear you when you talk about maintaining your
international competitiveness.

You are one of the few U.S. industries with a positive trade
balance and you want to keep it.

I understand that. I don't disagree.

I also understand that there are a host of unanswered
scientific questions about some of your products--about
biomaterials, about testing implantable products. How we proceed
on that front to get the safety and efficacy information we need
is of great concern to both you and us.

But let me also tell you what else I hear from other
quarters.

First of all, when a device on the market is found to be
unsafe, I hear from everyone. Consumers want to know that when
FDA approves a product for marketing -- when we say to them: "Go
ahead, it's all right"--that it is all right. They want to know
that we have settled the safety and efficacy questions as best we
can prior to marketing.

Given some of our experiences over the last few years-- with
the Shiley heart valve, breast implants, and Orcolan, their
concern is that perhaps we aren't vigilant enough.

Consumers also want to know if FDA is being vigilant about
monitoring products once they are marketed. I'm asked: "Are
manufacturers reporting problems to FDA? Is FDA following up?"

They want us to enforce the law and protect the consumer.
They want to make sure that we are looking at things from the
patient's point of view. And I also hear from our own CDRH.
What is CDRH saying?

Quite simply, they are under a lot of stress. Congress has
given them new responsibilities, but not the resources to do the
job. I'm talking about CLIA, about mammography legislation,
about SMDA.

The number of applications is growing enormously. But it's
not just the numbers. It's also the complexity of the
applications we are now receiving.

I hear all of this--from you, from the public and the
policymakers, from my FDA colleagues. A lot of different
perspectives to consider. But perhaps we're not all so far
apart.

A couple of weeks ago, I sat down with Alan Magazine for a
serious talk. We discussed a range of issues. And I can tell
you, that I think there was more agreement than disagreement. On
many matters, we are probably closer together than you might
think.

Let me get specific. Let's run through a few examples.

First, leadership.

When Jim Benson, my good friend and colleague, decided to
move on, I knew I had to put another strong leader in charge of
CDRH. That's what I did when I named Bruce Burlington to the
post.

I know your industry had some questions about the choice--
about putting an M.D. in charge, especially one who had recently
been working within the Center for Drugs.

But go beyond that initial concern and look at what Bruce
brings to this job. Bruce has an exceptional history as a
successful manager. He deserves much of the credit for turning
around our generic drug program.

Before that, he ran a division within our Center for
Biologics devoted entirely to IND applications. And most
recently, he's been involved in international harmonization
efforts. So he's a hands-on manager.

I think it is also a real asset that he continues to see
patients. He uses the products you produce. He sees their
importance in medical practice. And he recognizes the importance
of small start-up companies in this field.

First rate management skills, real world experience--these
are qualities that we all want in the person who will lead the
Center through a challenging time.

A second area of substantial agreement is the importance of
addressing the review time for new applications.

We can agree that we need to reintroduce an important
element--predictability. Both in terms of how long a review is
likely to take and in making clear what data we need to complete
the review process.

As much as possible we all need to know what to expect,
what's coming down the pike. There needs to be better
communication between FDA and the sponsor during the review
process.

We need to be talking to you at the earliest stages of
device development. We need to communicate early on what we
expect in clinical trials.

As Alan Magazine has agreed, the problem is not that we need
to ratchet up the science in some applications. There is no
question: we need to do that. You've probably all seen the
Temple Report. The issue is that we need to be clear in advance
about just what kind of studies, what kind of data, we will
require to evaluate a product's safety and efficacy.

I can't emphasize enough that resolving problems early on is
a very important way to expedite the review process.

I mentioned earlier that the Center has enormous
responsibilities and insufficient resources. Sometimes we simply
have no choice but to rob Peter to pay Paul. One of Bruce's
challenges will be to find a way to carry out the Center's other
responsibilities-- enforcement, post-market surveillance,
regulatory research, while strengthening the review process.
That's a real challenge.

Over the past couple of years, additional resources for CDRH
has been number one on my request list through the normal
appropriations budgeting channels. And I will continue to make
that case. I understand that HIMA is against user fees for
devices, but you also need to understand that this Center is
under stress, and somehow we have to come to grips with that.

And that brings me to a third area: priorities.

We received more than 18,000 submissions last year, more
than half of them we considered major submissions And the number
keeps growing. Not all devices are equal. In the end, we must
give priority to devices that offer substantial benefits to
patients. Those come first.

I think Alan Magazine understands this.

Now, you may each think that your product is THE most
important one--and we may differ on that. But as a general
matter, I think we can agree that given the workload, we have to
set priorities, we have to do some triaging.

Another area where Alan and I found some common ground is
international harmonization. We at FDA have to work with the EC,
with Japan and Canada, to try to make the requirements for your
industry as similar---or compatible---as possible. We're doing
that with GMPs now.

This is in the interest of the public health, and it is also
in this country's economic interest

Finally, let me suggest one more point that I think Alan and
I agree on: it makes no sense to beat up on each other. There
simply is no payoff in that.

You have a creative industry that is critical to the
well-being of the American people. It has to flourish. But FDA
also had a critical job to do. And we have to do it right.

I've listed several areas where I believe there is more
agreement than disagreement. But let's be frank. I would have
no credibility if I stood up here and told you that we are in
full agreement on everything. I'm not going to pretend that
important problems don't remain between the FDA and your
industry.

Later in this conference you will hear from some of the CDRH
leadership: Bruce Burlington, Alan Andersen, and Ron Johnson.
I'm sorry to report that Alan Anderson has informed me that he
will be leaving the Agency as of April 30. He has done an
outstanding job under difficult circumstances and filling his
shoes will be one more difficult challenge for us. Bruce, Alan,
and Ron will be talking to you about some of the specific issues
we face as CDRH enters a new phase.

One of the most important things I have done in my tenure as
Commissioner of Food and Drugs is to make sure that there is
strong leadership in place at critical positions throughout the
Agency. Certainly CDRH is one of those. Leadership that can
bring about an even stronger, even more effective medical devices
program.

Now it's time for all of us to roll up our sleeves and work
with Bruce and his staff to make that happen.