The Department of Health and Human Services is expanding its role in the selection of outside technical advisers for the Food and Drug Administration, prompting some top-level FDA officials to fear that the scientific advice, used in the regulation of drugs and medical devices, is in danger of becoming politicized.
Several FDA officials, who asked not to be named because of concern about their jobs, cited examples of HHS suggestions for the influential posts involving persons with ties to the president's family, the Republican Party and the antiabortion movement, as well as nominees from Capitol Hill conservatives.
In one case, a woman "right-to-life" activist was suggested for a committee that oversees contraceptives and abortion drugs, while Nancy Reagan's stepfather, Dr. Loyal Davis, was listed as a reference for another.
HHS Secretary Richard S. Schweiker and his top aides denied that there was any concerted policy to emphasize political considerations in selecting scientists for the panels.
Schweiker's chief of staff, David Newhall III, emphasized that technical qualifications were still the chief factor, but added that "if the scientist or doctor happens to have been chairman of 'Physicians for Reagan' in Nevada, so much the better."
This is the second time recently that the question of politics has been raised in connection with the selection of outside scientists providing technical advice. Late last month Agriculture Secretary John R. Block ordered a stop to a policy of making political checks on university scientists reviewing grant applications.
Both FDA scientists and policy makers say selecting members for FDA's 31 advisory committees generally has been delegated in the past to the FDA itself. But their complaints go beyond an unresolved bureaucratic turf fight.
In a recent confidential memo, FDA Commissioner Dr. Arthur Hull Hayes Jr. told Schweiker that efforts to centralize appointing powers in HHS's advisory committee office could result in the naming of less-qualified personnel and eventually in regulatory decisions made on less than the best available scientific assessments.
Unlike many policy-oriented advisory committees throughout the federal government, FDA's committees are composed largely of medical researchers, practitioners and other technical experts. They provide guidance in assessing the safety and effectiveness of new and existing drugs and devices, and FDA staff members say their recommendations are followed frequently.
The legal authority to charter and appoint advisory committees falls with the HHS secretary, who oversees FDA, but by tradition the power largely has been delegated to the FDA commissioner.
In the case of the Fertility and Maternal Health Drugs Advisory Committee, for example, final selections have not yet been announced, even though a slate of FDA-recommended names was reportedly sent up last July. According to FDA sources, HHS sent back some of its own suggestions, one of whom was a woman psychiatrist whose resume identified her as a founder of the California Pro-Life Council, a group that lobbies for antiabortion legislation.
She was proposed for the "consumer slot" on the panel, a position previously filled with nominees recommended by an outside consumer consortium.
FDA scientists judged the woman unqualified--in part, one source said, because of concern about how her "moral or ethical views" might affect committee reviews of contraceptives or drugs that might be used for abortions.
Another HHS candidate was an elderly California obstetrician-gynecologist whose resume listed neurosurgeon Dr. Loyal Davis, Nancy Reagan's stepfather, as a reference. "With all due respect, the candidate was not in the forefront of his profession," said an FDA scientist.
"They're trying to stack an obviously sensitive committee," complained an FDA scientist, who contended that some of the candidates' "main claim to fame is that they belong to certain groups or are with the Republicans."
In other instances, HHS has referred physician candidates to medical devices committees at the suggestion of Republican North Carolina Sens. Jesse Helms and John P. East.
One candidate's resume specified that his interests were the "same" as Helms', and another's political activities included the county Republican executive committee and chapter leader for the John Birch Society.
In recent months, internal FDA complaints have centered on a growing tendency for HHS to withdraw appointment authority when charters come up for renewal, particularly in FDA's Bureau of Drugs. HHS has taken this step in 10 out of 13 cases during the Reagan administration, by FDA's count.
But it was a new effort by Schweiker's advisory committee director to assume control of the nine scientific committees legally required to help classify and regulate medical devices that drew the unusually sharp memo last month from FDA Commissioner Hayes.
He urged Schweiker not to adopt his staff's recommendation, saying that the "current trend to centralize the management of advisory committees" is "running in the wrong direction."
His memo also suggested that the proposed change might result in a "significant" slowdown in the product-approval process and create "extra paper work" at a time of dwindling staff resources. FDA estimates that over the past six months its advisory committee workload has tripled in response to recent departmental requests.
Hayes declined to discuss the matter because it was still "under discussion." The HHS staff said Schweiker had not yet made up his mind, and pointed out that attempts to assume greater secretarial authority had begun under President Carter's HHS secretary, Patricia Roberts Harris.
One longtime FDA scientist agreed that "we've long had normal bureaucratic tensions" over advisory committees, but added "this is very different," both in the number of committees involved and in the greater attempt to suggest candidates.
Others said, however, that it was too early to tell what effect the changes might have, because few secretarial appointments have actually been made to the advisory panels.
Garrett Cuneo, a former member of Reagan's California gubernatorial staff who heads HHS' advisory committee office, declined to be interviewed about what selection criteria he is using in referring candidates.
But one top HHS staff member, accusing agencies like FDA of developing an "incestuous" relationship with their own network of scientists, said Cuneo's office was attempting to "broaden the pool" and bring more "uniformity" to HHS' overall appointments.
Although most current and past FDA officials contacted could not personally recall partisan politics as a major selection factor, many noted that previous administrations had taken affirmative action and geographic distribution into account.
Dr. Donald Kennedy, president of Stanford University and an FDA commissioner during the Carter administration, said that should partisan politics become a major factor, it "will destroy the advisory committee system and eventually damage the quality of scientific advice."
Peter Hutt, a respected FDA general counsel during the Nixon-Ford years, expressed a "firm belief" that the agency was better equipped to appoint its own advisory committee members. He had no objections to using broad, nonscientific considerations to help balance their membership, but said that he does not see "political affiliation as a valid criterion."
Meanwhile, the tug-of-war over authority apparently is causing delays in appointments to some panels.
Dr. David F. Archer of the University of Pittsburgh, the outgoing chairman of the fertility and maternal health committee, recently wrote to Schweiker to complain about this, warning that appointments should not be "limited by political or minority convenience." In an interview, he added, "They could be a pink-and-purple Martian as long as they have the knowledge."