JANE HENNEY: THE RIGHT PRESCRIPTION FOR THE FDA?
They say Washington can't match the vicious political infighting of academe. If so, then heading the Food & Drug Administration--one of the hottest seats in government--should be a tea party for Dr. Jane E. Henney.
In 1994, the University of New Mexico tapped the ex-cancer researcher to oversee a merger of its hospitals and medical, pharmacy, and nursing schools--all fiercely independent. She pulled it off. "What made her so effective was that she really does listen," says medical school dean Paul B. Roth. That'll come in handy as Henney, 51, tries to win confirmation from a GOP-controlled Senate worried that she may slow development of medical devices and push for the abortion drug RU-486. If she survives the Senate gauntlet, the former FDA deputy commissioner will have to deal with such problems as tainted food and drugs that prove harmful after approval.
It doesn't help that Henney, nominated by Clinton on June 23, wasn't the top choice of Health & Human Services Secretary Donna E. Shalala, among others. Shalala had been pushing acting FDA Commissioner Michael A. Friedman, who has won high marks from his bosses at HHS as well as drug industry execs. White House pols, however, were eager to name a woman. And Henney has a powerful backer in Senator Edward M. Kennedy (D-Mass.). Henney's husband, Dr. Robert Graham, executive vice-president of the American Academy of Family Physicians, was once an aide to Kennedy. But Republicans and drugmakers worry that Kennedy might exert undue influence over the agency. One trade group, the Medical Device Manufacturers Assn., already opposes Henney.
There's no disagreement, though, that the FDA needs a manager capable of carrying out reforms mandated by Congress and launched by the controversial former FDA chief, David A. Kessler. And management, Henney's backers say, is her greatest strength. Indeed, as Kessler's deputy in the early '90s, she reorganized much of the agency's operations.
The challenges facing the FDA are very different from the Kessler years of 1991-97, however. After restoring teeth and credibility to a defanged and scandal-scarred agency, he came under pressure from the GOP Congress to approve drugs and devices faster and to work more cooperatively with industry. Now, the FDA is okaying new drugs in record time.
But the agency's responsibilities are expanding faster than Congress' willingness to fund them. As a result, FDA officials confess they're doing a lousy job in such areas as making sure imported food is safe. With food imports up sharply--along with incidents of contamination--the problem is a high priority. In early July, Clinton reiterated his call for a $100 million food safety initiative that would include $25 million to expand the FDA's international inspection force.HASTY APPROVAL? FDA insiders also worry that their surveillance of approved drugs isn't up to the task. Case in point: The agency is bracing for more criticism if new wonder drugs such as Viagra continue to be linked to a string of health problems and deaths.
Henney will face a tough grilling in the weeks ahead as Senate and industry critics try to force her to take firm stands on key issues. For instance, how would she balance the conflicting pressures to approve products quickly while also assuring safety? So far, Henney has been mum. "We need to know what her philosophy is," says Alan H. Magazine, president of the Health Industry Manufacturers Assn., which has withheld an endorsement.
But Henney's boosters aren't fretting. They predict that the same quiet manner that disarmed the academicians of New Mexico will soothe the politicos of Washington.By John Carey