FDA to Appoint Safety Director

WASHINGTON – Buffeted by criticism, the Food and Drug Administration (search) said Friday that it would appoint a director of drug safety and take other action to assure the safety of medications it approves.

As sick and elderly Americans competed in lotteries for scarce flu vaccine, members of Congress chided the FDA for relying on the word of Chiron Corp (search)., the vaccine's manufacturer, rather than investigating as aggressively as British regulators.

Critics also have charged the FDA ignored risks associated with antidepressants and the blockbuster drug Vioxx, then tolld reporters that a great majority of consultations with drug reviewers easily reach consensus.

Galson called highly publicized disagreements so uncommon they don't merit tweaking the agency's culture to ensure dissenting views are heard.

"It's a rarity. It doesn't represent the culture, so we don't really think there is a need for an overwhelming cultural change," Galson said.

However, Dr. Eric Topol, the Cleveland Clinic cardiologist who pointed to increased cardiovascular risks with Vioxx in 2001, said he's spoken to at least three other FDA researchers who complained the agency minimized their concerns about the drug.

"There has been a climate there ... of suppression of ideas and concerns," Topol said.

Lester M. Crawford, acting FDA commissioner, said the agency's stamp of approval means American drugs are the world's safest. "The measures we are taking are designed to strengthen this quality as well as our consumers' confidence that FDA's processes ensure the highest protection of the public health," he said in a statement.

Galson said the FDA will name a director of the Office of Drug Safety, vacant since October 2003, to oversee the safety of drugs after their approval.

In addition, the agency is asking the Institute of Medicine to study whether improvements are needed to tease out more about a drug's side effects as it comes into more widespread use. The study also will examine whether the agency is too close to the drug industry to regulate it effectively.

The institute is an arm of the National Academy of Science, an independent agency chartered by Congress to provide the government advice on scientific matters.

"We are very proud of our independence," Galson said. "We think most of the charges that have been leveled are just not accurate."

To bridge differences among its scientific reviewers, the agency said it would convene an independent panel to review documents and make recommendations.

Acting commissioner Crawford said the FDA'S clinical reviewers and epidemiologists "evaluate and respond to identified concerns. This is what occurred recently with antidepressants and Vioxx."

Yet, in both cases reviewers told members of Congress they faced resistance within the agency after raising alarms.

This week, the FDA released a report by David Graham, the associate director for science, that said safety concerns about the drug continued to mount after 2000. Besides heightened cardiovascular risks, the drug was linked to "significantly increased" risk of hospitalization for gastrointestinal bleeding.

Also, the editor of the journal The Lancet pointed this week to "lethal weaknesses" in FDA's regulatory oversight. "Too often, the FDA saw and continues to see the pharmaceutical industry as its customer -- a vital source of funding for its activities -- and not as a sector of society in need of strong regulation," Richard Horton wrote in the British medical journal.

The FDA statement did not respond, directly, to The Lancet's allegation.