Revamping The Fda Without The Stridency
Food & Drug Administration chief David A. Kessler was wary when Representative James C. Greenwood (R-Pa.) called to set up a June meeting. After all, Greenwood was steering through the House an FDA reform bill that Kessler had testified could put patients and consumers at risk. "You clearly have the votes to ram this through," Kessler pointed out. "Why negotiate with me?"
Greenwood's reply marked a new tack for a Republican Party still smarting from the failure of its 1995 revolution. The House had muscled through a staggering number of bills, only to see them gutted or killed in the Senate. Now, the GOP had to prove it could deliver results. "I told Kessler I wanted a bill that the President will sign," Greenwood says.
COMPROMISE. The upshot: a marathon June 18 session with Kessler that led to several compromises. A revised package due when Congress returns from a holiday recess on July 9 is expected to streamline the FDA's approval of manufacturing processes, give the agency authority to use outside reviewers, and let companies submit summaries of clinical trial data under some circumstances. In addition, it will fix what Greenwood admits were technical errors in the original draft "that could be interpreted as having nefarious results."
There are thorny issues to be resolved. The FDA is balking at the GOP plan to let companies promote unapproved uses for drugs already on the market. And despite a narrowing of differences on drug regulation, the two sides are far apart on medical devices and food. Even so, "there are things that could be worked out so the Republicans could say they have a bill that's passable," concedes a top FDA official.
If the bill becomes law, Greenwood deserves much of the credit. The second-term congressman "is a practical guy, not an ideologue," explains William W. George, chief executive of Minneapolis medical-device maker Medtronic Inc. "He's the ideal person to work this through the House."
Indeed, Greenwood's approach is a turnaround for the GOP, which made the FDA a favorite whipping boy. House Speaker Newt Gingrich called Kessler a "bully and thug," and other Republicans accused the agency of killing people by being too slow to approve new lifesaving products. When House Commerce Committee Chairman Thomas J. Bliley Jr. (R-Va.) asked Greenwood to head an FDA reform task force in March, the debate was polarized.
But the former Bucks County (Pa.) social worker reached out to all sides. "I basically said that to get this done, it has to be bipartisan," he says. Industry execs applauded. "He was really a breath of fresh air," says James S. Benson, senior vice-president of the Health Industry Manufacturers Assn.
CRITICS. That hasn't made Greenwood immune from sniping, however. Democrats say he could have saved time and avoided mistakes by enlisting their help in writing the bill's language. FDA reform advocates fret that he's compromising too much. And industry hands warn that the real power remains with the more conservative Bliley.
Moreover, getting legislation passed this year is uncertain. With only a few legislative days left before the fall election, "our biggest enemy now is the clock," says Greenwood. And when the bill reaches the floor, he may have his hands full fending off amendments to keep the FDA from regulating tobacco or approving abortion drugs.
Still, Greenwood remains optimistic. Even if his efforts fall short this year, he's showing Republicans how they should have gone about their revolution.