"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.
jonathan.rockoff@baltsun.com
CONTROVERSIES AND THE FDA REFORMS THEY PROMPTED
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]
