Former FDA heads convene

Four former U.S. Food and Drug Administration commissioners discussed controversial issues that have politicized the agency in a panel discussion Wednesday afternoon in the Jack Morton Auditorium.

The event, sponsored by the GW Medical Center’s Project on Scientific Knowledge and Public Policy, drew about 200 professors, doctors and government employees to campus. The FDA protects public health by regulating human and veterinary drugs, biological products, medical devices, cosmetics and the U.S. food supply. The four former commissioners’ combined FDA leadership spanned three decades.

All commissioners saw the delayed agency approval of the emergency contraception Plan B for over-the-counter use as the best example of politics impeding the agency’s mission. Many who opposed the contraceptive accused the agency of approving its use for political reason.

David Kessler, the FDA commissioner through both Presidents George H.W. Bush’s and Bill Clinton’s administrations, said the chief executive office could do a lot to improve the agency’s image.

“We all work for the president of the United States,” Kessler said. “If the president wants to make a decision because he believes something should be available, then come out and say it.”

All of the commissioners agreed that the FDA must remain an agency that has no political agenda. Dr. Donald Kennedy, who served during the first half of President Jimmy Carter’s administration, said the agency’s work is blemished when politicians accuse it of idealism.

“I’m more deeply concerned about the tendency of political appointees and officials to rework or reinterpret scientific findings in the pursuit of particular policies,” Kennedy said.

Young, who served as commissioner of the FDA under President Ronald Reagan for about five years and passed the first AIDS prevention drug, said the current White House has been particularly harassing to the FDA.

“Some administrations, and in particular this one, have thought that it was important to build some backfires against what it regards as an over appetite for regulation,” Young said.

He also stressed the need for the agency to restore balance between having quality research versus having a large number of approvals. Young said the agency’s lack of resources are a problem and called on the president and Congress to help so the FDA can maintain a staff of more academically qualified researchers.

“I believe that the FDA needs to be a high priority for the administration and the Congress – for the administration to avoid not only the political meddling, but the lip service.” he said. “The (personnel) turnover in the agency is just shameful.”

Commissioners also discussed the controversy surrounding the approval of a vaccine that prevents the sexually transmitted Human Papilloma Virus, Gardasil.

The virus accounts for 70 percent of cervical cancer cases in the United States, according to the Centers for Disease Control and Prevention’s Web site. On Wednesday, a report from the CDC stated that 542 complaints about the vaccine, including fainting, dizziness, fever or nausea. Some oppose the vaccine, saying it will encourage sexual activity in young women.

Former FDA Commissioner Dr. Jane Henney, who served from 1998 to 2001 and was the first female commissioner, cautioned parents and girls thinking about taking the vaccine to understand the inherent risks involved. She said although she is excited about what Gardasil means for women’s health, legislation making vaccines compulsory is unnecessary.

She said: “I think right now it may be a little premature for (mandates).”

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