FDA Privatization Battled

FDA Privatization Battled

Debate over the Food and Drug Administration reform bill heated up off the Senate floor today, as the same coalition of public health, consumer, and environmental groups that helped derail the 1996 effort to privatize portions of the agency launched what appears to be an uphill battle to scuttle this year's less far-reaching measure as well.

At a news conference in the hearing room where the measure was approved 14-4 in June by the Senate Labor and Human Resources Committee, representatives of the groups charged the bill would severely threaten the health and even lives of millions of Americans. Under the bill, said Joan Claybrook, president of Public Citizen, "FDA's responsibilities will be broken up and auctioned off to special interests who put profits before the public health."

Of particular concern to the groups is the provision that would pre-empt states from regulating or requiring labeling of cosmetics, including such everyday items as soap, toothpaste, and shampoo.

"Testing of the pesticides in your dog's flea collar is more extensive than that of cosmetics," charged David Wallinga, a senior scientist with the Natural Resources Defense Council.

Senate Labor and Human Resources ranking member Edward Kennedy, D-Mass., said he plans for "a full opportunity" to debate the measure when floor consideration resumes, although he stopped short of saying he would filibuster. Kennedy and Sen. Richard Durbin, D-Ill., are among those expected to offer amendments to alter the provisions most disliked by consumer and health groups - including not only the cosmetic pre-emption, but also potential conflict of interest problems associated with private third-party review of medical devices and removal of a requirement for mandatory tracking of medical device problems.

In a separate meeting with reporters, Sen. Bill Frist, R- Tenn., a major backer of the bill, said he was feeling "upbeat" about the measure's prospects, despite the complaints.

"When we get it to the floor, people will recognize the extent of the negotiations that have already taken place," Frist said. He noted most of the issues that plagued the 1996 measure have been resolved, and the remaining issues on this year's bill "are all manageable issues that can be addressed and I predict will be addressed."

But while Frist said he would vote for amendments that "make sense and improve the bill," he seemed disinclined to limit the contentious provision pre-empting state cosmetic regulation. "This whole idea that the federal government is overriding the states' ability to protect the consumer is false," he said, contending that the language now included in the bill allows states the flexibility they need to preserve the public health.

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