FDA chief lays out plans for healing the agency

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CORRECTION

A story in the Business section Friday mischaracterized FDA Commissioner Andrew von Eschenbach's position on the agency's role in tobacco oversight. He said the FDA "clearly has a role" in addressing the public health problem of tobacco. Congress is considering legislation that would require the agency to regulate tobacco, but the FDA "does not have the infrastructure in place" or the technical expertise, Eschenbach said.

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The Food and Drug Administration has increasingly come under fire for not doing its job.

In the past four years, the agency that regulates about 20 percent of the U.S. economy has been criticized for exposing patients to medicines that do more harm than good, letting contaminated imports get into the country and failing to protect the food supply.

Dr. Andrew von Eschenbach, an oncologist and cancer survivor who was appointed head of the FDA in 2006, was in the Triangle on Thursday to talk about initiatives started on his watch to treat the ills of the agency.

During a conference that brought about 200 health-care executives to the SAS campus in Cary and included a visit to The News & Observer, Eschenbach said the FDA is in the middle of fundamentally changing how it operates, expanding its traditional role as a gatekeeper. Switching from paper to electronic data is a big part of the change, which Eschenbach sees continuing after the next president appoints a new FDA commissioner following the election in November.

"These are endemic shifts that will carry on regardless of who's at the head of the agency," he said. Here are some highlights of other issues he discussed:

* DRUG SAFETY:

It's difficult to track side effects of drugs that are already on the market, and the pharmaceutical industry and physicians haven't done a very good job reporting problems. To better allow patients to report bad reactions to drugs they're taking, the FDA is revamping its Web site.

Reports from physicians and others will be combined with information regulators hope to get from health insurers, which for years have gathered data on prescription-drug use and medical claims. Eschenbach said the two initiatives should alert regulators to early warning signs, allowing them to step in and request warnings on the packaging information or ask that a drug be withdrawn from the market.

Regulators also are working more closely with university researchers, the pharmaceutical industry and colleagues within the FDA. To keep up with medical discoveries, the position of FDA chief scientist was created. Dr. Frank Torti, director of the cancer center at Wake Forest University in Winston-Salem, was appointed this month to fill the position.

* ELECTRONIC DATA:

The FDA is investing more than $200 million to upgrade its 20-year-old data management system. A new data center will be operational in about a year. The goal of the overhaul is to replace paper filings with electronic data capture and storage.

* CONTROLLING DRUG PRICES:

The FDA doesn't have the power to set the prices of products it regulates. But the agency can "make the regulatory pathway more effective and efficient," which should help reduce the cost of drugs and medical devices. The FDA also is trying to get more generic drugs on the market, reducing costs for consumers.

* INFORMATION ACCESS:

One of the biggest challenges for the FDA is to make sure that personal medical information remains confidential while consumers gain better access to data collected to participate more in decisions related to their health.

* TOBACCO REGULATION:

The FDA "clearly has a role" in addressing the public health problem of tobacco. Congress is considering having the agency regulate tobacco, but the FDA "does not have the infrastructure in place" or the technical expertise, Eschenbach said. Such authority would require a bigger budget and more resources.