Agreement on Food and Drug Administration reform legislation continues to elude administration officials and Senate Republicans, forcing Majority Leader Trent Lott, R-Miss., to invoke cloture on the measure Tuesday morning, White House and congressional sources said Monday night.
Sources said Monday that the main sticking point between the White House and Senate Republicans is a provision in the bill governing FDA regulation of off-label uses of medical devices.
The administration wants to guarantee that the FDA can regulate off-label uses, especially in cases when labeling may be misleading or fraudulent.
A Senate Democratic aide said Monday night that administration officials are trying to address Republican concerns that this may give federal officials too much regulatory power, proposing that "an advisory commission of experts" determine that the device will be employed for off-label uses, according to the Senate aide.
Or, the FDA would have to prove that the labeling was fraudulent, he said. A White House source said officials are continuing to try to hammer out an agreement.
Sources said a dispute over a provision governing FDA issuance of environmental impact statements under the National Environmental Protection Act has been resolved.
The issue had been of importance to Vice President Gore and Labor and Human Resources ranking member Edward Kennedy, D-Mass. Kennedy argued last week that the FDA legislation would have precluded "the FDA from taking environmental considerations into account in its work."
If no agreement on remaining issues is reached, Kennedy appears inclined to force use of the full 30 hours of debate allotted under cloture.
"The assumption is that he will have no alternative, but he will consult with the leadership and the administration," a Senate democratic aide said Monday.
However, the source expressed optimism that agreement will be reached soon. Another Democratic aide said that agreement was likely to be reached today.
White House health care adviser Chris Jennings indicated that negotiations were "moving quickly," and predicted speedy passage of the measure once it is considered by the Senate.
Jennings added the White House was also trying to ensure that pediatric labeling provisions in the bill are "complementary" to regulations recently announced by President Clinton.
It was unclear as of late Monday whether debate on the FDA bill would actually be scheduled for today.
Kennedy, who led Senate opposition to another provision governing federal pre-emption of state cosmetics regulation, is not directly involved in the negotiations over device labeling. Last week, Kennedy announced the cosmetics issue, which sources described as the toughest of the remaining issues, had been resolved to his satisfaction.
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