By Lisa Seachrist

Washington Editor

WASHINGTON — Calling it "symbolic of what we should be doing as a country," President Clinton signed the FDA Modernization Act of 1997, which reauthorizes the Prescription Drug and User Fee Act (PDUFA) for five more years and enacts sweeping changes in the way the agency regulates medicines, medical devices and foods.

While signing the bill, the president did not take the opportunity to announce his candidate for heading the FDA, as some industry sources had speculated he would.

This bill is the product of three years of rancorous debate in both the 104th and 105th Congresses, and the president and members of Congress attending the ceremony held at the Old Executive Building drew attention to that fact in their remarks.

"I just think it is worth pointing out that at the beginning of the process the sides stood worlds apart — I think that is an understatement," Clinton said. "If somebody told me two years ago, two years from now you'll be standing at the Old Executive Building and you'll sign a bill passed by the Congress by a voice vote and it will be a sweeping reform of FDA, I would have taken odds against that."

Senator Jim Jeffords (R-Vt.), who used his position as chairman of the Labor and Human Resources Committee to spearhead the FDA reform effort in the Senate, told BioWorld Today that reform took three years because it is "difficult to build consensus from a situation of such wide disagreement and lack of confidence in each other."

"This year the Congress changed," Jeffords said. "We knew we had to get this done to serve our country and ourselves as well. That is why this became a true bipartisan effort."

Early in the year, Jeffords made it clear he intended to use the need to reauthorize PDUFA as a vehicle for FDA reform. Even though committee markups of the legislation proceeded smoothly, reform got hung up for more than a month in the Senate by Sen. Edward Kennedy (D-Mass.) over medical device and cosmetics provisions. In the end, compromise language from the House legislation on medical devices allowed for the bill to pass on voice votes in both the House and the Senate.

"The long and contentious debate in Congress laid the groundwork for the many constructive compromises that made this day possible," Kennedy said a prepared statement. "The result is bipartisan legislation that effectively balances competing interests and protects the public health."

With the signing of the bill, the agency must establish how it is going to implement the reform law.

"This is one day to celebrate a major victory," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "But, tomorrow we go right back to working with the FDA and the administration to make sure this is fully implemented."

Feldbaum noted that BIO also has begun meetings with Vice President Al Gore's staff to address additional administrative changes at the FDA via Gore's Reinventing Government Initiative.

"PDUFA doesn't come up again for another five years," Feldbaum noted. "We may not get another legislative vehicle for reforms before then. We must push ahead by other means." *