FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT

FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT

Fri, 4 Mar 2005

The Washington Post reports about yet another instance of a high FDA official who misspoke. Dr. Sandra Kweder, Deputy Director of FDA’s Office of New Drugs, sent a letter, “written on official FDA stationery, accusing the Cancer Letter of ignoring Society of Professional Journalists guidelines on privacy.” The newsletter informed its readers who the 5 candidates for FDA’s new Office of Oncology were. Dr. Kweder and (evidently) the FDA regard the dissemination of information about nominees for public office “unethical.”

Robert D. Lystad, First Amendment counsel to the group and a lawyer with Baker & Hostetler, charged 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.”

The Los Angeles Times reports that the Senate committee, HELP, is wavering about what changes are needed in the way the FDA functions in order to improve drug safety.

Dr. Raymond Woosley, a recognized expert and long-time critic of FDA’s corner cutting with safety issues, urged that new drugs be introduced gradually.

“After initial approval, they would be available only to limited populations of patients, and would have to be used to treat the particular condition for which they were approved. After a time, the drug could be used more broadly.” Dr. Woosley also urged the creation of a computerized registry to track the experience of patients using new drugs, and compare the results with those of patients using older drugs.

The LAT reports that beyond questions of how the FDA should be reorganized, “some lawmakers want to consider restrictions on advertising prescription drugs directly to consumers, and curbs on high-pressure industry sales campaigns aimed at doctors.”

Contact: Vera Hassner Sharav
212-595-8974

THE WASHINGTON POST
FDA Official Calls Report Unethical
By Marc Kaufman

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.

© 2004 The Washington Post Company

THE LOS ANGELES TIMES
Senators Consider Safety Reform at FDA
By Ricardo Alonso-Zaldivar, Times Staff Writer

WASHINGTON – After weeks of neutrality, a key Republican lawmaker said Thursday that recent internal reforms by the Food and Drug Administration did not do enough to protect patients from drugs with potentially deadly side effects.

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee that has jurisdiction over the beleaguered agency, said he would explore options for bipartisan legislation with Massachusetts Sen. Edward M. Kennedy, the ranking Democrat on the committee.

“Doing nothing to address the current controversies is not an option,” said Enzi, whose committee would handle any FDA reform bill.

Speaking at the close of two days of drug safety hearings, Enzi said he was seeking a “comprehensive response” to the need for congressional action that was acceptable to “both sides of the aisle.” He said he recently met with the FDA’s leading congressional critic, Sen. Charles E. Grassley (R-Iowa), to discuss possible legislation.

FDA Deputy Commissioner Janet Woodcock, testifying before Enzi’s committee, said the agency had learned its lesson from the recall of Vioxx, an arthritis painkiller withdrawn from the market after a study confirmed long-standing concerns among some experts that it raised the risk of heart attacks and strokes. “We plan to put information out to the public directly about emerging safety issues,” Woodcock said.

“We will be getting information out to people who need it in a timely manner.”

The FDA also is pursuing other internal reforms, including: creating a drug safety board, setting up a process to fully consider dissenting opinions from its own experts and bringing in an outside group from the federal Institute of Medicine, part of the National Academy of Sciences, to evaluate its safety program. Woodcock said the agency was more focused on safety than at any time in its history, and that changes were underway that should prevent recurring problems.

But Enzi said he was considering several suggestions for further changes.

Kennedy favors granting the FDA authority to require safety monitoring by companies after a drug has been approved. He called on Congress to increase funding for the FDA’s safety program. The FDA should have explicit authority, which it does not now have, to order labeling changes for a drug when safety concerns arise, Kennedy said. Currently, the agency must negotiate wording changes with drug makers, a process that can take months.

A key question in any legislation would be the future of the FDA’s drug safety office, now a unit of the division that decides whether a drug should be approved. Woodcock acknowledged there was a potential for drug reviewers to form an “intellectual bias” in favor of a medication they had cleared.

Grassley has said the safety office should be separate from the division that reviews drugs. Many medical experts concur, and some believe the safety office should be an independent agency, modeled on the National Transportation Safety Board. Enzi and FDA management oppose creation of a safety office outside the agency.

Beyond questions of how the FDA should be reorganized, some lawmakers want to consider restrictions on advertising prescription drugs directly to consumers, and curbs on high-pressure industry sales campaigns aimed at doctors.

Two outside experts who testified before Enzi’s committee urged lawmakers to consider sweeping changes.

Dr. Raymond Woosley of the University of Arizona said the drug approval process “fails to detect serious adverse effects of products until they are on the market, often for years, and millions of Americans have been exposed to potential harm.”

That is true in part because pre-approval trials involve relatively small numbers of patients and problems may not appear until larger numbers have been exposed to the drug.

Woosley urged that new drugs be introduced gradually. After initial approval, they would be available only to limited populations of patients, and would have to be used to treat the particular condition for which they were approved.

After a time, the drug could be used more broadly. Woosley also urged the creation of a computerized registry to track the experience of patients using new drugs, and compare the results with those of patients using older drugs.

Dr. Bruce Psaty of the University of Washington in Seattle said the approval process should give greater weight to resolving potential safety problems. In the case of Vioxx, a theoretical possibility of heart risks was acknowledged, but not fully investigated, before the drug was approved. “If manufacturers do not address the potential risks and benefits with equal scientific rigor, the FDA must insist they do so, both before and after approval,” Psaty said.

He called for a new Center for Drug Safety, within the FDA, with the authority to order studies or conduct its own, to impose labeling changes, restrict advertising and suspend or withdraw drugs from the market.

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