Health

FDA pledges better communication on drug safety: AMNews interviews Andrew von Eschenbach, MD

■ The commissioner outlines ways in which physicians can expect to see change.

By Susan J. Landers — Posted April 7, 2008

WITH THIS STORY:
» Andrew von Eschenbach, MD
» New two-pronged safety plan for FDA
» Correction
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Washington -- Muscle provided by Congress last fall was intended to allow the Food and Drug Administration to police drugs already on the market. Findings from this effort could enhance physicians' understanding of a medication's potential for harm or their ability to identify patients at risk for adverse events.

Now the issue is how to get word of these findings to physicians quickly. Current methods, such as the FDA's "Dear Doctor" letters, don't always reach physicians. Figuring out which new communication approaches and technologies will work is one of the challenges the agency faces.

The FDA Amendments Act of 2007 provided more funds to monitor drugs through their life cycles as well as authority to require warnings or studies when risks are first suspected.

In the lead-up to this change, the agency's reputation as drug safety watchdog took major hits when drugs such as the pain reliever Vioxx and the diabetes drug Avandia were pulled from the market. (See correction)

FDA Commissioner Andrew von Eschenbach, MD, has vowed to improve the agency's record.

AMNews: Should doctors be looking for more messages from the FDA?

Dr. von Eschenbach: We feel strongly communications need to be timely. It is something we have to look at from both sides of the equation.

We have to be careful about saturation and overload. We don't want to be Chicken Little, but we want doctors and care providers to know what we know as early as we know it and then participate in it. But we want to put it in context. We'll tell you when it is something that demands your attention and immediate action, and we'll tell you when it is something we are concerned about but are still gathering information on. And we hope you will help us with that. It will take a little time to get there.

AMNews: How will you do this?

Dr. von Eschenbach: What the FDA wants to do is collaborate and cooperate with the AMA, with nurses, with pharmacists, with the media disseminating information and with the pharmaceutical and biotech industry that also disseminates information. What we want to do is to try to get it right.

We all grew up with the Physicians' Desk Reference, which is a great tool, but in the 21st century it is not the appropriate tool. We are going to move to communications that are not paper-based but electronic-based. It won't depend on one thing, but it will depend on our ability to put in place a variety of strategies, and we will have to do it in collaboration with those who are partnering with us so they know what we know when we know it, in real time.

AMNews: Are physicians reporting their observations on drug effects to the FDA?

Dr. von Eschenbach: No. We don't have all the tools in place yet for them to do this. One of the most effective communication tools today is the Web, and the FDA is doing a complete revision of its Web site. We started a year ago revising it for consumers. It is now far more user-friendly than it was before. It is written in styles appropriate to patients and to physicians, who will have a separate entry portal.

AMNews:MedWatch is already in place. Isn't that effective?

Dr. von Eschenbach: MedWatch isn't going away. We are trying to enhance it.

AMNews:What kind of feedback will you want from physicians?

Dr. von Eschenbach: It's a spectrum. First of all, I think it's important for them to feed back to us whether the information we are providing to them -- whether it's a patient label, medication guide or a public health advisory -- is effective, useful and whether it is accessible in a way that is helping them in their practices.

We have to engage in a dialogue that respects the fact we have to make regulatory decisions about these products. We have to determine whether products should or should not be on the market and whether the way they are being utilized is being framed properly by the label. And we can't do that without physicians telling us what is happening, because they are on the front lines.

We need to ask them to share medical information and data. I know as a physician it is a burden in a very busy practice, in time, energy and effort. And I know, for many, it is a burden financially to put their practice information on an electronic medical record database. But that's what has to be done. It's not just so it's more efficient for them in office management, but so they can use and process that information in a way they can learn from the experience. And if they can share that information with us and contribute to a larger pool, we will know so much more.

AMNews: What about the solo physician in a rural practice?

Dr. von Eschenbach: They may not have the scale and scope, but they do have the experience. On a case-by-case basis, their experience may be more insightful than others' experiences. Sometimes, even in a small practice, encountering a very unusual outcome may lead to discoveries you can't even imagine.

AMNews:When you were in practice six years ago, did you find it difficult to keep up with FDA information?

Dr. von Eschenbach: It's a problem across the board for physicians trying to keep up. You go from reading every journal article, to reading every abstract, to the abstracts in your area of interest. You have to hone down.

Also a challenge was how other people are using information. Patients would come in with information they had gotten off the Web. It's not an absence of information but an abundance of information, and you need to define good information. For patients, that's confusing.

A challenge for both the AMA and the FDA is to be seen as the source of accurate and reliable information. We want the physicians and the consumer to see us as the source of the most accurate, most insightful and most complete information about medical products, drugs, biologics and devices. Because we are at the epicenter, we know more about those products than anyone else, including the person who discovered it or is making it, because we are gathering information across the spectrum.

AMNews:Does the FDA have enough money to do its job?

Dr. von Eschenbach: We've seen increases in 2007 and 2008, and we hope to see increases in 2009. But to do more, we need more. I hope the American people, through their representatives, will see this as a crucial and absolutely worthwhile investment.

ADDITIONAL INFORMATION

Andrew von Eschenbach, MD

Position: Commissioner, Food and Drug Administration

Medical school: Georgetown University School of Medicine, Washington, D.C.

Age: 66

Family: Married with four children

Noteworthy

Sworn in Dec. 13, 2006, as the 20th FDA commissioner
Director, National Institutes of Health National Cancer Institute, 2001-06
President-elect, American Cancer Society, at the time of NCI appointment
Prior to joining NCI, he held several positions at the University of Texas M.D. Anderson Cancer Center in Houston

New two-pronged safety plan for FDA

Food and Drug Administration Commissioner Andrew von Eschenbach, MD, oversees the development of new risk communication strategies from what he has described as the 40,000-foot level. Meanwhile, agency staff are at work on the ground crafting a nuts-and-bolts plan to improve the oversight of drugs after they reach the market.

One new initiative, Safety First/Safe Use, is intended to help sharpen the agency's focus on pharmaceuticals throughout their lifespan. Now in its earliest phases of development, the initiative will build on new authority granted to the agency by Congress last fall as part of the FDA Amendments Act of 2007.

The Safety First portion of the two-pronged effort sets out the responsibilities of the various FDA offices in managing safety issues, wrote Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a staff memo. The new authority "bolsters our ability to manage safety throughout the life cycle of pharmaceutical products."

The second part of the effort, Safe Use, which is the less-developed portion, will likely hold the most interest for physicians, said Deborah Henderson, director of the Office of Executive Programs at the FDA's Center for Drug Evaluation and Research. It will focus the same close management attention on the safe postmarket use of drugs as the agency has placed on the premarket phase that leads to approval, she said.

The agency has always seen its role as primarily one of "getting the label right," said Henderson. "We don't want to become regulators of doctors. But with all the medical errors and the misuse, the underuse and overuse of drugs on the market now, we feel we need to step up to the plate and be active, full partners with the health care community."

Exactly what new tools will be developed or which old tools reshaped remains to be determined, Henderson said. "I think you will see more of an effort to partner with organizations like the AMA, the pharmacists and the nurses to figure out how we can work with the health care community to give you all this wonderful information we have."

Correction

This story incorrectly referred to the diabetes drug Avandia as having been withdrawn from the market. The drug remains on the market, but its label carries a black-box warning. American Medical News regrets the error.