In the spirit of Washington's annual trial-balloon season, the head of the Food and Drug Administration has tossed aloft the idea of letting private industry help foot the bill for his agency's research on toxic substances.
FDA officials confirmed that Commissioner Frank Young has circulated the idea among agency officials and outside scientists, describing it as a sort of "blind trust" that would accept contributions from industry, foundations and other nongovernmental institutions.
But the suggestion has stirred a small tempest in an FDA advisory panel, and the agency is taking pains to explain that it is "only one of many options" Young has been considering.
"It's nothing that he has decided about, is committed to or has any certainty about pursuing," agency spokesman Bruce Brown said.
The idea of financing government research through corporate donations may be the fastest sinker since the Andrea Doria. Nevertheless, it provides an illuminating example of how ideas get floated through the bureaucracy, occasionally rising to the level of formal proposals but more often falling victim to a well-aimed pin from below.
The concept of tapping nongovernmental funds for federal research is not new. Brown said the concept "has been discussed by FDA in the past, and has been rejected after some honest disagreements on its merits," mostly on the part of agency attorneys concerned about the potential conflicts of allowing regulated industries to pay for studies that might affect the marketability of their products.
In an era of budget austerity, however, officials have a habit of dusting off even the most shopworn ideas for another trial flight.
So it was that Young, who took over as commissioner in July, mentioned his interest in the "mechanism of a blind trust" to Dr. Ronald W. Hart, director of the FDA's National Center for Toxicological Research in Jefferson, Ark.
As one of the FDA's largest research facilities, the toxicological center presumably would stand to benefit from such an arrangement. Because most of the center's work is done under contract with other federal agencies, its financial standing depends not only on the FDA's budget but also on the amount of research funds allocated to other agencies.
Hart brought up Young's idea at a meeting of the center's science advisory board in late September.
Science advisory boards are common in science-based regulatory agencies, generally functioning as overseers and reviewers of scientific data. It isn't unusual to float policy proposals by such groups as a way of boosting their credibility. According to the minutes of the September meeting, the board thought Young's idea was terrific.
Its chairman, Dr. Ronald Estabrook of the University of Texas, wrote to Young on Oct. 22, assuring him of the board's "strong support" for the concept and offering to use "our collaborative resources" to put the blind trust into place.
At least one member of the advisory board had strong reservations about the blind trust, however, and he hauled out a sharp pin.
The dissenting member was Albert Meyerhoff, an attorney for the Natural Resources Defense Council, who took "strong exception" to the letter to Young.
In a letter to Estabrook, Meyerhoff warned that the blind trust idea had not appeared on the board's agenda, as required by the Federal Advisory Committee Act, was not subject to formal debate and was not formally approved by the board.
"In my judgment, should the commissioner now act based upon this 'advice,' any such action would be subject to a successful legal challenge," he wrote.
Meyerhoff said that he had raised the same questions at the meeting, and that he was perplexed that Estabrook had sent the letter anyway.
"I was told that we would only endorse the idea in concept, not the details," he said. "But I'm a lawyer, and I never endorse anything in concept until I learn the details. I learned that at my father's knee: Trust your mama, but cut the cards."
Estabrook declined to discuss his letter to Young, calling it a "confidential" communication.
Hart, who initially broached the subject at the advisory group meeting, also demurred, saying that what he and Young really had in mind was a way to get industry representatives, federal regulators and others together for "nonadversarial" communication.
Estabrook, he said, was "more enthusiastic than was warranted."
Brown, meanwhile, said the FDA is still seeking ways to "introduce or expand the concept of user fees," but said the blind trust "is not even off the ground."