Washington Editor

WASHINGTON - Senate members were singing the same songs on embryonic stem cells last week, striking familiar chords for and against funding the research with more taxpayer dollars.

And according to the leading proponents of expanding federal backing for embryonic stem cells, a vote on a bill to do just that is likely to come next month. "This is a high priority," Sen. Edward Kennedy (D-Mass.), the chairman of the Health, Education, Labor and Pensions Committee, said at a joint hearing Friday. And Sen. Tom Harkin, the chairman of the appropriations subcommittee on Labor, Health and Human Services, and Education added, "This is the year to do it."

Harkin then went a step further, indicating that the legislation, "The Stem Cell Research Enhancement Act of 2007," could go straight to the Senate floor next month, skipping the markup process that could add language to make it more palatable to opponents. He said that's the thinking of Majority Leader Harry Reid (D-Nev.), who introduced the measure, S. 5, at the beginning of the new congressional session.

In contrast, a minority party staff member told BioWorld Today that the bill could get marked up as early as Wednesday, when the HELP Committee is scheduled to meet on pending business matters. If so, the staffer said the measure could have language added from S. 51, a bill introduced by Sen. Johnny Isakson (R-Ga.) to improve research into human pluripotent stem cell lines derived from techniques that do not knowingly harm embryos.

"Some of us very earnestly believe life begins at conception," said Sen. Tom Coburn (R-Okla.). "That has to be respected; that position is not taken lightly."

He was countered by Sen. Orrin Hatch (R-Utah), a pro-life member who has nonetheless ardently supported embryonic stem cells. Labeling the research "handcuffed," he held up a shiny silver set of restraints as he advocated for federal support of all types of stem cell science.

All this Senate action follows the House of Representatives' recent vote to pass its version of the embryonic stem cell funding bill, 253-174. Labeled H.R. 3 and sponsored by Reps. Diana DeGette (D-Colo.) and Mike Castle (R-Del.), it's identical to the measure that President Bush vetoed last year, H.R. 810. (See BioWorld Today, Jan. 16, 2007.)

He's expected to do so again.

In the House, 290 votes are needed to override a veto, and the Senate requires 67. Harkin said the bill's proponents have a "hard count" of 66 votes, and added that more of his colleagues could be persuaded with further education on the matter.

Committee Vote Scheduled On Genetic Bill

At Wednesday's HELP Committee meeting, members are expected to vote on legislation that would protect against genetic discrimination.

The measure, which received a shot in the arm last week when the president called on Congress to pass it, would prevent health insurers from denying coverage or adjusting premiums based on an individual's predisposition to a genetic condition, and would prohibit employers from discriminating on the basis of predictive genetic information.

"If a person is willing to share his or her genetic information, it is important that that information not be exploited in improper ways," Bush said in a speech at the National Institutes of Health, "and Congress can pass good legislation to prevent that from happening."

Called the Genetic Information Nondiscrimination Act, it is being pushed by Sen. Olympia Snowe (R-Maine), who has said it would free people to use genetic tests without fear of negative consequences. She first introduced the bill nearly 10 years ago.

The Senate has approved the measure by unanimous margins twice before, in 2005 and 2003.

FDA Proposes Cord Blood Regulations

In a draft guidance issued last week, the FDA said it would allow cord blood banks to cite existing data in a public docket for licensure instead of submitting their own clinical findings, offering a less burdensome registration path for minimally manipulated products to treat hematological malignancies.

The data permit the development of recommendations for establishment and processing controls and product characteristics for those products.

Because the agency considers unrelated, allogeneic, hematopoietic stem or progenitor cells to have a systemic effect, it regulates them as biologic drugs and human cells, tissues and cellular and tissue-based products, subject to licensure.

Current rules require that cord blood establishments register with the FDA. The agency is accepting comments on its proposal for the next three months.