FDA Official Calls Report Unethical

Naming of Candidates for Post at Issue

A top Food and Drug Administration official accused a Washington-based cancer newsletter of unethical behavior last week in publicly naming five people in the running to direct a new office for cancer drug products.

Office of New Drugs Deputy Director Sandra Kweder sent a letter, written on official FDA stationery, accusing the Cancer Letter of ignoring Society of Professional Journalists guidelines on privacy. She said that naming the candidates could delay or undermine efforts to fill the post.

But Kirsten Boyd Goldberg, the editor and publisher of the newsletter, rejected the criticism as misguided and an attempt at intimidation. She said her publication will continue to aggressively report on issues important to people interested in cancer policy, including the names of people vying for significant agency positions.

A First Amendment lawyer for the journalists' group went further, charging that Kweder and the FDA, and not the cancer newsletter, had broken the ethical rules.

"The FDA is turning the society's code of ethics on its head," said Robert D. Lystad, First Amendment counsel to the group and a lawyer with Baker & Hostetler.

"The candidates for this important government post are not the 'private people' that the society had in mind in drafting this particular provision on privacy. . . . Reporting on candidates like these is what public scrutiny should be all about."

The dispute comes at a time when the FDA is working hard to become more open about its decision making. After some employees accused the agency last year of stifling internal dissent and withholding bad news, top FDA officials said they wanted the agency to become more transparent in its actions.

An FDA official said yesterday that Kweder was exercising her individual First Amendment rights in writing the letter, which does not necessarily represent the views of the agency.

In the Feb. 25 letter, Kweder quoted from the group's code of ethics that "[o]nly an overriding public need can justify intrusion into anyone's privacy." Kweder added: "We see no overriding public need to speculate about the status of possible candidates involved in this job search."

Kweder wrote that "[w]e were disappointed to see a detailed report in The Cancer Letter . . . that included uncorroborated names of possible candidates."

Goldberg said that Kweder's use of the word "we" led her to believe that Kweder was speaking for the entire agency, and not just for herself.

The newsletter has been in the forefront of reporting about oncology issues at the FDA, and especially about the 2002 Erbitux cancer drug scandal that ultimately sent ImClone Systems Inc. founder Samuel D. Waksal and company stock investor Martha Stewart to prison.

The candidates named last month by the newsletter are competing to become director of the newly constituted FDA Office of Oncology Drug Products. The office will have oversight of both cancer drugs and biologics. Richard Pazdur, director of the Division of Oncology Drug Products, had been expected to lead the new unit. Instead, the FDA decided to conduct a national search for a director.

As reported by the newsletter, the five candidates for the job are Pazdur; Patricia Keegan, director of the FDA Division of Therapeutic Biological Oncology Products; Karen Weiss, director of the agency's Office of Drug Evaluation VI; Charles Schiffer of the Barbara Ann Karmanos Cancer Institute; and John Marshall of the Vince Lombardi Cancer Center.