FDA: Clinton Nominee Could Face Fight In Senate
President Clinton yesterday nominated University of New Mexico administrator and cancer specialist Dr. Jane Henney to head the Food and Drug Administration, drawing immediate concerns from political observers that her confirmation could face opposition in the Senate. Henney served as the FDA's deputy commissioner under former Commissioner David Kessler, who drew fire for his attempts to gain agency authority over tobacco, among other actions. The Washington Post reports that members of Congress saw Kessler as "a symbol of over-aggressive government" and were wary of some of his actions as commissioner, including "his attempt to crack down on health claims made for foods and nutritional supplements." While legislators and industry leaders said yesterday they know little about Henney, the Post reports that her work under Kessler and strong backing by Sen. Edward Kennedy (D-MA) could be sticking points among Senate Republicans. Several GOP congressional aides also said legislators are interested in whether Henney was involved in the FDA's promotion of RU-486, the so-called "abortion pill."
Biotechnology Industries Association chief Carl Feldbaum called Clinton's nomination "as important a nomination as the FDA has ever had in its history." He said the agency's new commissioner will face a balancing act between "'people in the agency who want no change or slow change' and some people in industry and Congress 'who think any change in beneficial'" (Schwartz/Dewar, 6/24).
A 'Consensus Builder'
Henney's backers called her a "consensus builder" and said "she will be no clone of Dr. Kessler," the New York Times reports. "She doesn't come into this with a lot of baggage one way or the other," said Chris Jennings, Clinton's deputy assistant for health policy (Stolberg, 6/24). "She didn't focus on issues," said University of New Mexico Associate Vice President Linda Suydam, who served with Henney at the FDA. "She focused on good management practices and making sure the FDA ran well, that it ran efficiently and effectively" (Vanderkam, Washington Times, 6/24). If Henney is confirmed by the Senate, she will be left to "navigate a political minefield of issues." Especially "daunting" will be putting into effect legislation passed by Congress last year that will speed the review of new medicines. One top official at the Department of Health and Human Services said Henney's expressed support of the law will be crucial during confirmation hearings, adding that it is important that Henney "makes clear" that speeding up approval times "is going to be her top priority." But Public Citizen's Dr. Sidney Wolfe said Henney might "not be tough enough" for the FDA's top post. "I am very worried about the crisis of the FDA, which is the rush to approve too many drugs," Wolfe said (New York Times, 6/24).
Henney's First Challenge?
As Clinton taps a new FDA head, the agency is facing criticism that its system for monitoring drugs is "too reactive, too dependent on drug company data and inadequate to keep pace with about 250,000 reports of adverse drug reactions each year." The Wall Street Journal reports that the FDA will spend $10 million on drug surveillance this year -- about 6 cents for each dollar it spends on evaluating new drugs. "Basically, nobody is looking for problems," said Brian Strom, chair of the biostatistics and epidemiology department at the University of Pennsylvania. "It's convenient for industry and the FDA because no one is looking over their shoulders," he said. Some physicians say they do not prescribe a new drug right away because they are wary of the FDA's monitoring system. But FDA officials say recent drug recalls, including the recall this week of American Home Products Corp.'s painkiller Duract, are evidence that the system is working (Sharpe, 6/24).