By Lisa Seachrist

Washington Editor

WASHINGTON — Difficulty in passing the Departments of Labor and Health and Human Services appropriations bill has slowed the Senate's consideration of the FDA Modernization Act — S. 830 — the vehicle for reforming the agency and reauthorizing the Prescription Drug and User Fee Act.

The Senate began considering S. 830 after an 89-5 vote for cloture Friday and ended eight hours of debate over bringing the bill to the floor Monday. Majority Leader Trent Lott (R-Miss.) had indicated the Senate would vote on a motion to proceed with the bill Tuesday at 4 p.m. However, debate on amendments to the Labor and Health and Human Services appropriations bill spilled over that deadline and S. 830 won't be up for consideration again until the Senate clears the appropriations bill from its docket.

More importantly, however, Sen. Edward Kennedy (D-Mass.) has stated he will delay the bill in an effort to remove Sen. Judd Gregg's (R-N.H.) provision, which allows federal preemption of states' rights to regulate cosmetics and over-the-counter drugs.

"Many optimists thought that after the cloture vote we would have the bill passed in the Senate this week," said Jeff Trewhitt, media officer for the Pharmaceutical Researchers and Manufacturers of America (PhRMA). "In terms of timing, I am not sure too many people are saying that now."

The vote to invoke cloture limited the time for debating whether the Senate would consider the bill. During that debate, Kennedy made it clear he opposed the cosmetics provision, noting it was never adequately considered during Senate hearings.

In addition, Kennedy said he had some issues with medical device manufacturing and classification provisions in the bill. A Kennedy spokesman, however, noted those issues likely will drop to the wayside or will be resolved should the cosmetics provision be dealt with adequately.

Kennedy has two more opportunities to slow S. 830's path through the Senate and buy some time for working out his issues with the cosmetics provision. First, when Lott returns to S. 830 once the appropriations bill passes, Kennedy could threaten filibuster in consideration of the bill, forcing Lott to request another cloture vote. Such a move would require that the motion ripen for two days before the Senate could vote to invoke cloture and limit debate to a maximum of 30 hours.

Kennedy could also make a motion to appoint conferees, threaten filibuster and force another cloture vote in order to slow the Senate's likely passage of the bill.

Under this scenario, a vote on the bill is unlikely before late next week.

"Kennedy has made it quite clear that the cosmetics issue is a continuing concern," Trewhitt said. "He has a mechanism to force two more cloture votes if he chooses. It's ironic that none of the pharmaceutical or biologics issues are causing the delay." *