Congress working for drug safety

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.


"What worries me is that without congressional intervention, this could happen again," Rep. Frank Pallone Jr., a New Jersey Democrat, said at a House subcommittee hearing last week.

Spurring the legislative effort is a big push from the drug industry and consumer groups, which are often at odds but have joined forces amid the current crisis.

"Your bill is an historic opportunity to fix these problems," William K. Hubbard of the Coalition for a Stronger FDA, told Pallone at the House hearing.

Lately, FDA officials have joined in the calls, testifying that the agency needs $225 million in added funding to inspect overseas facilities every other year by 2011 and $10 million more to upgrade computer tracking systems. Officials are also seeking expanded authority, including the powers to stop suspect shipments at ports and to destroy adulterated products from overseas.

"I am extremely concerned about pharmaceuticals," Dr. Janet Woodcock, director of the FDA's drug division, said at a recent hearing. "The world is changing, and our ability to assure the safety of the drug supply has been diminished. Heparin is a wake-up call."

The Bush administration began talking about reform in November, when Health and Human Services Secretary Michael O. Leavitt released an import safety plan under which the FDA would place inspectors in China and other countries, encourage drugmakers and importers to police their supply chains, and work with foreign governments to make sure products meet U.S. standards.


Leavitt disagreed with some Democratic ideas for improving the safety of drug imports but said he would work with Congress.

"Hopefully, we'll be able to come together," he said.


1937: Diethylene glycol in elixir sulfanilamide (prompted 1938 Food, Drug and Cosmetic Act, including the requirement that the FDA review drugs before they can be sold.

1958: Rachel Carson's "Silent Spring" (pesticide amendments)


1962: Thalidomide (prompting the requirement that the FDA, in reviewing drugs, make sure before approval that they aren't just safe, but also work effectively)

1976: Dalkon Shield (medical device amendments)

1980: Baby deaths and illness from deficient formulas (Infant Formula Act of 1980)

1982: Tylenol poisonings (1983 Anti-Tampering Act)

1987: Counterfeit birth control pills (Prescription Drug Marketing Act of 1988)

1990: Steroid abuses (Anabolic Steroid Act of 1990)


1992: Outcry by patients and AIDS groups on slow review of new drugs (Prescription Drug User Fee Act)

2002: 9/11 (Bioterrorism Act)

[Source: Coalition for a Stronger FDA]