Washington Editor

WASHINGTON - Senate Majority Leader Bill Frist (R-Tenn.) is singing a new song on embryonic stem cell research, but his tune probably won't do enough to secure expanded federal funding.

"Embryonic stem cell research must be supported," he said on the Senate floor Friday before beginning month-long congressional recess. "It's time for a modified policy - the right policy for this moment in time."

While his support increases the likelihood that the Senate will pass the Stem Cell Research Enhancement Act, which already cleared in the House, President George Bush's veto power remains a likely obstacle. The administration continues to indicate that the measure won't be signed into law. "Nothing has changed in terms of his position," White House Press Secretary Scott McClellan said at a Friday press briefing.

Given the administration's recalcitrance, and because there do not appear to be enough votes in either chamber to override a presidential veto (though the House shortage is greater than in the Senate), the bill could be dead in the water. Labeled H.R. 810, it passed in the House by a 238-194 margin more than two months ago. More recently, senior Republicans have urged its passage in the Senate, and getting Frist to join them is proving crucial to those efforts. (See BioWorld Today, May 26, 2005, and July 14, 2005.)

"Given the fact that he's a highly respected physician and the Senate Majority Leader, what he says carries a lot of weight," said Ronnie Tepp, the national director of government relations at the Juvenile Diabetes Research Foundation in New York. She added that his perspective could also sway other Senate members who are still struggling with the issue.

Not surprisingly, Frist's comments also resonated loudly outside the beltway. His remarks that embryonic stem cells hold promise "that adult stem cells cannot provide" provide added hope to those fighting to gain more federal money for research.

"I think that now that there's a stem cell majority in this country," said Susan DeLaurentis, CEO of the Alliance for Stem Cell Research in California, "we've seen a shift in a lot of Republicans' views." But she added that she was concerned that Frist would not bring H.R. 810 to the Senate floor "in the form that it's in for a vote."

Frist said the bill "has significant shortcomings" related to ethical and scientific oversight, and added that it doesn't prohibit financial or other incentives between scientists and fertility clinics and fails to specify which party has the final say about whether an embryo will be implanted or discarded. "These shortcomings merit a thoughtful and thorough rewrite of the bill," he said.

DeLaurentis added that rewrites of the measure could dilute its effectiveness, but Tepp told BioWorld Today that "at the end of the day, he said he would still vote for the bill."

Notably, he said the measure should be considered on its own, separate of "a whirl of amendments and complicated parliamentary maneuvers." The Senate likely will consider the bill at some point after reconvening following Labor Day.

"While human embryonic stem cell research is still at a very early stage, the limitations put in place in 2001 will, over time, slow our ability to bring potential new treatments for certain diseases," Frist said. "Therefore, I believe the President's policy should be modified." He added that federal funding and current guidelines governing stem cell research should be expanded "carefully and thoughtfully, staying within ethical bounds."

Energy Bill Passes Through Congress

Both houses of Congress last week approved an energy bill laden with incentives that could provide a boost to the industrial side of biotech.

The Senate voted 74-26 to approve the legislation, which finally has moved forward after several years of delays, a day after House members voted 275-156 in favor of the measure. The bill includes $14.5 billion in tax breaks, as well as a notable provision requiring nearly double the amount of plant-produced ethanol as a gasoline additive by 2010. The act also provides credit for ethanol made from non-traditional feedstocks like wheat straw and corn stover.

Now that the compromise bill cleared Congress by a wide margin, President Bush soon is expected to sign it into law.

Another Drug Import Bill Floated

Still sounding the trumpet for drug reimportation, a congressional quartet introduced legislation in the House and the Senate to block trade agreements that preclude such a practice without the consent of drug patent owners.

"The majority of Americans recognize that prescription drug importation is a free trade issue," said Sen. Debbie Stabenow (D-Mich.), who last week addressed the proposed measure with Sen. David Vitter (R-La.) and Reps. Anne Northup (R-Ky.) and Rosa DeLauro (D-Conn.).

Their legislation calls for preventing the U.S. Trade Representative from signing agreements that would block importation of prescription drugs into the U.S. due to patent provisions.

FDA Shuffles Upper-Level Staff

Just weeks after receiving Senate confirmation, FDA Commissioner Lester Crawford made several personnel changes at the agency. Scott Gottlieb was named deputy commissioner for medical and scientific affairs, Janet Woodcock will become deputy commissioner for operations and chief operating officer, Murray Lumpkin will become deputy commissioner for international and special programs, and Patrick Ronan will be Crawford's chief staff officer.

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