Remarks as Prepared at the Sentinel Press Conference

Good afternoon and welcome. It’s a pleasure to be here today. I am very excited to talk to you about a new, proactive surveillance capability we are building at the FDA. It’s called Sentinel, and as the name suggests, it will tremendously increase the FDA’s capacity to monitor the use of medical products on the market.

Today marks a major milestone in that effort, as a new Medicare regulation now gives CMS and FDA the tools needed to launch a collaborative pilot project that will get Sentinel off and running.

This collaboration also enables government and stakeholders to know more about the value and efficacy of the drugs we’re using. That’s an important component of the value-driven health-care system I’ve spoken to many of you about before.

Here with me today are two people who deserve much of the credit for the launch of this pilot: FDA Commissioner Andy von Eschenbach and CMS Administrator Kerry Weems.

Andy and his team have been the chief architects of our Sentinel initiative. They have done great work in building strong partnerships in the public and private sectors to advance it. And Kerry and his team have played an instrumental role in working with the FDA on using Medicare claims data to power the Sentinel system.

In a moment, I’ll have each of them tell you more of the specifics of this effort. But first, I’d like to say a few words about its significance.

As you all know, the FDA works hard to ensure that we understand the safety profile of new medical products before they are approved for use. FDA approvals are based on scientifically valid tests, typically including anywhere from a few hundred to a few thousand subjects. FDA approval is trusted by scientists around the world.

But often a product’s side effects appear only over time, among a small subset of patients. They won’t be noticed until well after the product reaches the market, when many more people are using the product, under conditions that the pre-market trials can’t create.

When side effects are noticed, a doctor, nurse, or patient may suspect a new product to be the cause. They may also report their suspicions to the FDA. But they may not.

Even when they do, it often takes many cases before someone detects a pattern worth reporting. So getting enough reports to raise a red flag can take time.

Then there’s the challenge of establishing whether the product actually causes the suspected side effect. FDA can query many sources of information. But there is no system in place to do this rapidly using the massive electronic datasets maintained by the federal government and the private sector.

That is where Sentinel comes in.

Before Sentinel, tracking drug safety was like looking at the stars from your backyard with the naked eye. You could only see what was over your own head from far away.

After Sentinel, you have been given the strongest telescope on the market, which lets you see precise details from great distances. Plus, your new telescope shows that the stars have been trying to send you messages by pulsing and shining brighter. At times, some stars shine brighter and patterns begin to take shape — but you couldn’t see that until now because you didn’t have the right tools.

There are such exciting possibilities created by this new capability. With Sentinel, the FDA will be able to query databases of tens of millions of patients almost simultaneously. It will no longer have to wait for reports to trickle in from the field. It will be able to proactively identify specific adverse effects among particular types of patient populations. And it will be able to get this information to health-care providers much faster, so they can contact their patients.

Sentinel will start with a database of more than 25 million people enrolled in Medicare’s Part D prescription drug benefit. Later it will add private databases through partnerships with private firms. This will help establish the safety of products not often used by the Medicare population.

FDA will not receive information identifying individual patients, so patient privacy will remain protected.

This is a very important step we are taking today. We are moving from reactive dependence on voluntary reporting of safety concerns — to proactive surveillance of medical products on the market. The result will be much improved safety protections for all Americans.

Now, before I begin answering your questions, I’d like Andy and Kerry to tell you a little more about Sentinel and its Medicare pilot project.

Last revised: August 29, 2008