By Jonathan D. Rockoff , Sun reporter|May 06, 2008
WASHINGTON — WASHINGTON -- Spurred by the public's deepening fears of deadly imports, Congress is moving to give federal health officials the added money and new police powers they have long wanted to fix a broken drug safety system.
After years of criticizing the Food and Drug Administration's failures, Democratic and Republican legislators are coming together on strengthening the embattled agency.
"FDA is overstretched in terms of its responsibilities and underfunded," Sen. Edward M. Kennedy, a Massachusetts Democrat, said at a hearing last week on the agency's troubles.
Congress faces the difficult task of finding hundreds of millions of dollars in funding. And ideological differences and election-year politics could dampen the chances for a quick agreement on the details.
"Hopefully, we can come to a consensus, but it is going to take work, and we on the Republican minority side are not going to be a rubber stamp," Rep. Joe L. Barton of Texas said at a recent hearing.
Republicans oppose House Democrats' idea of paying for more foreign inspections through user fees on overseas plants.
House Democrats, meanwhile, have scoffed at FDA proposals - popular among Republicans - to focus agency inspections on the riskiest companies and to rely on independent companies to certify that plants follow good manufacturing practices.
Rep. Bart Stupak, a Michigan Democrat who has held several hearings on the FDA's shortcomings and needs, said in a recent interview that improvements might have to wait for a new administration.
Yet, Democrats and Republicans alike say that Congress needs to take action.
Current and former FDA officials say the degree of concern reminds them of other crises that led to major changes at the agency, including reforms in 1962 prompted by the scandal over thalidomide, a drug that was used to treat morning sickness until it was found to cause birth defects.
"I'm just hoping we can find a way to get together and give the FDA the resources to do what needs to be done," Sen. Orrin G. Hatch, a Utah Republican, said during a Senate health committee hearing last week.
The growing consensus follows recalls of a string of deadly imports from China, most recently of the blood thinner heparin, which was found to have a chemical replacing the drug's main ingredient that investigators have linked to 81 deaths in the United States. The contaminant might have been deliberately added during production in China, perhaps to generate bigger profits, FDA officials have speculated.
