Government
HEW panel concludes FDA behaved improperly Triggered by allegations made by FDA staffers in 1974, report finds that management mistreated employees, recommends policy changes The Food & Drug Administration isn't dominated by the drug industry, but it has been guilty of some less than ethical dealings with its employees—particularly those who could turn thumbs down on new drug applications. So says a report by a blue-ribbon panel of lawyers and scientists who investigated charges by FDA employees during what Health, Education & Welfare Secretary Joseph A. Califano calls "a troubling episode in FDA's history." The "troubling episode" occurred in the late 1960's and early 1970's. Allegations of impropriety at FDA first came to light in August 1974 when 11 current or former FDA staffers charged at Senate health subcommittee hearings that their recommendations to disapprove drug applications were almost always questioned by FDA management. Their recommendations for approval of drug applications, however, were never questioned, the group told subcommittee chairman Edward M. Kennedy (D.-Mass.). The employees also charged that they were punished by FDA for failing to approve drug applications from friendly pharmaceutical firms with transfers to insignificant jobs in the agency. Generally, they affirmed that the pharmaceutical industry had undue influence over FDA and its drug review methods. FDA itself investigated the charges, and issued a 900-page report in November 1975 that cleared the agency of any wrongdoing. Not everyone was satisfied by the report, including FDA's parent, the Department of Health, Education & Welfare. HEW set up a special outside panel to look into the matter, and the current report is the result. The panel was chaired by Norman Dorsen, a professor of law at New York University, and included scientists such as Dr. David P. Rail, director of the National Institute of Environmental Health Sciences. The final panel report, put together by HEW special counsel Frank E. Schwelb, found that: • Although FDA was not dominated by the drug industry during the period in question, "inappropriate contacts" with pharmaceutical firms took place. 18
C&ENMay 2, 1977
Califano: a troubling episode • Beginning in 1970, FDA management made a conscious effort to be less "adversarial" and more cooperative with certain drug manufacturers, and it tried to "neutralize reviewing medical officers who followed a different philosophy." • As a group, the medical officers who testified before Congressional committees about the alleged abuses "belonged to the more adversarial or critical school of drug reviewers" that agency management sought to neutralize. • The neutralization program was accomplished by various means, including a systematic pattern of involuntary transfers to positions the employees had not sought, and in a few cases removal of the employee from the review of certain new drug applications. • Some of the involuntary transfers probably violated Civil Service regulations; others were carried out in "an unprofessional and discourteous manner." • FDA management generally hid the real reasons for the transfers from employees, and in one case in 1972 agency officials actually gave false testimony under oath about the reasons for a transfer. In many ways the 765-page report reads like the script of a television soap opera. It contains charges and countercharges by employees and FDA management including "rudeness," "obstruction," and "anti-industry bias." In some cases, individuals interviewed in the report appear to have only vague recollections of the events. Nevertheless, special counsel Schwelb makes a number of strong recommenda-
tions in the report, including possible criminal action against Dr. Henry Simmons, a former director of FDA's Bureau of Drugs, for allegedly giving false testimony at a grievance proceeding brought by one of the FDA dissidents, Dr. John 0. Nestor. Schwelb believes the matter should be brought to the Justice Department for action, although he concedes that he probably wouldn't do so if he were a federal prosecutor. Justice has declined to take action against Simmons. The report further recommends that officials at HEW and FDA apologize to present and former employees who were treated improperly by FDA. And in a memo to new FDA commissioner Donald Kennedy, HEW Secretary Califano urges that reprimands to FDA officials involved in the original controversy be dispensed quickly, even though Califano would not say whether the reprimands are justified at this point. He says he will leave that up to the new FDA management. Califano asked that FDA commissioner Kennedy report back to him by May 31 on new regulations that would prevent such abuses from happening in the future. Says Califano: "During my tenure as Secretary of the department, I am determined to eliminate any question of irregular procedures or improper influence in the decisions of FDA." The report suggests that such regulations should prohibit lying by FDA officials in agency matters and disciplining those who do, prohibit involuntary transfers as a "punitive device" and keep records to prevent such transfers, demand disclosure to employees of any industry complaints against them and give the employees the opportunity to tell their side of a story, and prohibit "disruptive, discourteous, or boisterous conduct" by FDA management or its employees. Almost as a footnote to the whole affair, a chapter of the report attempts to analyze the 1974 Kennedy hearings that made public the charges by the dissident employees. Then FDA commissioner Alexander M. Schmidt charged that the hearings were rigged against the agency and were designed to sensationalize the charges of the employees. Schmidt complained that, among other things, there was an unfair and unrepresentative selection of witnesses, and that they were routinely asked leading questions to elicit criticism of FDA. But in his letter to Califano, panel chairman Borsen notes, "the panel believes that it is beyond its jurisdiction to evaluate the practices and procedures of the Senate and therefore does not endorse the substance of the chapter." •
