FDA builds in the shadow of a threat

THE BALTIMORE SUN

WASHINGTON -- Even as federal officials prepare to embark on a nearly $1 billion plan to build a better, more cohesive Food and Drug Administration, critics of the agency are readying an assault that could lead to its extinction.

House Speaker-designate Newt Gingrich has said that he would like to see the FDA "torn down," because he views the agency as a barrier to entrepreneurial innovation and "the leading job killer in America."

The FDA is responsible for ensuring the safety and effectiveness of drugs, medical devices and many food products, a mission that gives it regulatory power over a quarter of the nation's economy.

Mr. Gingrich has been critical of the time it takes the FDA to test and approve new products, a delay that he says hurts the nation's ability to get the products to the international marketplace. He has suggested that the FDA be replaced by an agency staffed with scientists and medical entrepreneurs with limits on their time in government.

Tony Blankley, a spokesman for Mr. Gingrich, said the new speaker was working with the Progress and Freedom Foundation, a conservative think tank with close ties to Mr. Gingrich, to develop a proposal for replacing the FDA. Officials at the foundation declined to comment, saying their ideas for the FDA were still in the early stages.

Despite the criticism, FDA is forging ahead with a long-planned $890 million consolidation and modernization of its laboratories and offices at two sites in the Washington suburbs. One of the two sites will be in Montgomery County, along the Interstate 270 corridor, and it is scheduled to be unveiled today. The other is in Prince George's County.

The General Services Administration is scheduled to announce today the site of the $675 million Montgomery County campus, which will require the purchase of 350 to 540 acres of land for the construction of 2.6 million square feet of research and office space by the year 2003.

The campus will be home to state-of-the-art FDA laboratories, as well as support services, including a fire station, health-care unit, multi-media studios, a day care center and auto maintenance shops.

Congress has appropriated $325 million for the FDA consolidation, with the rest of the project scheduled to be funded over the next four years, said Jag Bhargava, development director for the GSA.

So far, there are no indications that Mr. Gingrich will try to block the rest of the money needed to fund the consolidation. But his broadsides have prompted congressional advocates to prepare to defend the cost of the consolidation.

"I think if you ask Americans, an overwhelming majority would agree that the federal government should be inspecting products to make sure our breakfast cereal is free of cockroaches, cough syrup is safe for our kids, and if the box says 'fat free' it means fat free," said Sen. Barbara A. Mikulski, a Maryland Democrat and a strong supporter of the consolidation project. "That's what FDA does. And this consolidation is going to help them do it better and faster."

The FDA project is being hailed as a boon to Montgomery County's economy because it promises to create thousands of construction jobs and solidify the county's role as a biotechnology hub.

FDA's 5,000 Washington-area employees work out of 40 buildings on 18 sites. Those facilities are typically old, in poor condition and overcrowded, federal officials have said.

The General Services Administration is scheduled to announce today the site for the campus from among three finalists: one near Rockville, one in Clarksburg, and one in Germantown. Once the site is selected, the agency will negotiate with property owners to determine a price.

In Prince George's County, the FDA is expected to spend more than $200 million on new food safety, nutrition and veterinary medicine facilities on an 100-acre site off the Baltimore-Washington Parkway at the Department of Agriculture's Research Center. Eventually, 1,400 people will work there.

County economic development officials have said that the work is expected to bring a $53 million federal payroll to the county and generate 1,100 jobs outside the FDA.

The FDA consolidation has been discussed for years. Once a $1.2 billion project by the Reagan administration, the plan was scaled back to $424 million by the Bush administration in late 1992. But with President Clinton's election, Marylanders in Congress successfully pressed for the more expansive consolidation.

"We have been working for four years to bring about [today's] announcement," Ms. Mikulski said. "The site selection is the key component to starting consolidation of FDA in Montgomery and Prince George's counties. The consolidation means jobs to Maryland -- construction jobs today and the high-tech, high- paying jobs of the 21st century."

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