The Senate will not discuss giving FDA a green light to approve generic versions of biologic drugs while the FDA reauthorization bill is on the floor, but senators do plan to take up the measure early this summer.

Health, Education, Labor and Pensions Chairman Kennedy said Wednesday his committee would mark up generic, or follow-on, biologic legislation June 13 after Senate leaders reached an agreement with New York Democratic Sens. Charles Schumer and Hillary Rodham Clinton, who proposed follow-on biologic legislation in February.

Kennedy said the agreement entails including the final biologic legislation in negotiations with the House during conference on the FDA reauthorization bill.

The final bill also is expected to be influenced by Kennedy and Sen. Orrin Hatch, R-Utah, who both favor giving brand-name biologic companies protections that would let them enjoy a lock on the market for a number of years before a generic can be approved.

On the FDA reauthorization bill, the Senate is expected to vote today to end debate on a provision to allow importation of lower-priced prescription drugs from other countries.

The vote might be close, with "a large number of Republicans" voting for it, although possibly not enough to end debate, Minority Whip Lott said. "It's not as much of a slam dunk as some people think," he said.

The vote is complicated by a second-degree amendment from Sen. Thad Cochran, R-Miss., to require the government to certify the safety of imported drugs. Critics say the amendment would render the reimportation language useless because the administration would use it to block drug imports.

Lott said the vote on Cochran's amendment also is unpredictable, adding he would vote against it. "If this is used by the pharmaceuticals, and administration, Democrat or Republican, not to let drugs in from Canada, for instance, I'm tired of that," he said. "Where I'm from, this is still America. If you want to order drugs from Trinidad and they kill you, congratulations, that's your choice."

Sen. Tom Coburn, R-Okla., said Cochran's amendment would allow him to vote for cloture on reimportation because he could then support Cochran's certification requirements. Sen. Ben Nelson, D-Neb., also said he would support cloture and then vote for Cochran's amendment.

Lott said Senate leaders tried, but failed, to negotiate an agreement to keep reimportation off the overall bill by agreeing to a stand-alone floor debate at a later date. The White House has threatened to veto legislation that includes reimportation.

Kennedy said that once the importation votes are over today, the Senate will vote on an amendment to close a loophole that brand-name drug companies use to stall generic drug approval.

If reimportation language is included in a Senate-passed bill, House Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., is faced with a dilemma.

Although he supports reimportation in general, he also has made it a priority to complete reauthorization of the prescription drug user fee program at FDA before the August recess.

Reauthorization of the user fee program is the crux of the Senate bill, but it has attracted other provisions related to drug safety, devices, and child research.

FDA will warn employees of pending layoffs in July if the reauthorization bill is not completed.

Pallone told CongressDaily Wednesday that any add-ons to the House version of the bill would be dependent on whether controversies about those provisions could be worked out this summer.

Senators unanimously approved an amendment Wednesday dealing with human and pet food safety. The provision would enhance surveillance and improve communication during a crisis.