Former FDA Heads See An Agency In Trouble

WASHINGTON — Four former commissioners of the Food and Drug Administration agreed Wednesday that distracting controversies and political interference with scientific decisions have damaged the agency's ability to ensure drug safety.

"We can't be left for long in the position we're in now," said Donald Kennedy, who headed the FDA in the Carter administration. "The agency has lost credibility, because too much has happened too fast, and there has been a lack of consistently credible leadership."

Kennedy appeared at a symposium sponsored by George Washington University here.

The other three were Frank Young, who served under President Reagan; David Kessler, who was appointed by President George H.W. Bush and reappointed by President Clinton, and Jane Henney, who also served under Clinton.

All cited controversies about the safety of licensed drugs and widespread reports of political interference in FDA decisions — especially over-the-counter sales of a "morning after" birth control pill — as symptoms of an agency that is in trouble.

Kessler, now chancellor of the Stanford University School of Medicine, also warned that the agency is not prepared for changes science will forge in the pharmaceutical industry.

He blamed drug makers' huge expenditures on development of "blockbuster" drugs for many of the agency's problems.

Other critics have said that with so much riding on profits from drugs that bring in a billion dollars a year or more, manufacturers bring enormous pressure on FDA to keep the substances on the market.

But, said Kessler, this will change as more precise medications are developed.

"It's the blockbuster that has gotten us in trouble," Kessler said, "but we're moving into an era when the question will be what is the right drug for the right person, the right disease, the right dose. 'Big Pharma' cannot be supported with that model, so there are going to be changes."

He added, "I seriously question whether FDA is going to be able to provide the intellectual firepower to be able to lead" the changes that will come.

Young and Henney decried what they viewed as growing politicization of the agency.

Henney recalled fighting White House political operatives during the Clinton administration who sent her a list "of dozens of Schedule C's," referring to politically selected government employees.

"I ended up having to take one of them," she said.

Young said, "I think there has been a progressive politicization of the agency."