Washington Editor

WASHINGTON - More stem cell legislation surfaced last week on Capitol Hill in yet another effort to sidestep President Bush's almost four-year-old restrictions, as the latest bill seeks to safeguard the use of nuclear transfer for research while banning human reproductive cloning.

Introduced in the Senate, it's called the Human Cloning Ban and Stem Cell Research Protection Act of 2005. While the use of somatic cell nuclear transfer for creating stem cell lines is legal in the U.S., no federal funds can support such work. The bill would reverse that.

"It puts in law the distinction between cloning for reproduction and cloning for research," said Michael Werner, the Biotechnology Industry Organization's chief of policy. "It gives a safe harbor for cloning for research."

The proposal was written by Sens. Orrin Hatch (R-Utah), Arlen Specter (R-Pa.), Dianne Feinstein (D-Calif.), Ted Kennedy (D-Mass.) and Tom Harkin (D-Iowa).

Werner said a similar bill is expected to soon come forth in the House of Representatives, as well.

Such bipartisan unity is a common theme with several of the recently introduced bills, which seek to establish federal funding for embryonic stem cell research through grants from the National Institutes of Health in Bethesda, Md.

That's certainly the case for one House bill, co-sponsored by Reps. Mike Castle (R-Del.) and Diana DeGette (D-Colo.), which has nearly 200 other House members on board. It stipulates that embryos must have been produced at in vitro fertilization clinics and be in excess. It also says donors must have received proper informed consent and there must be no financial incentives to offer embryos.

"House leadership has said there will be a vote on stem cells sometime soon," Werner told BioWorld Today, noting that moderate Republicans such as Castle have pressed the party's leadership to accept that this is not a partisan issue and that they won't back down until a vote is taken. "There's a companion bill in the Senate too, but right now all the action is in the House."

For the most part, the myriad congressional bills aim to supplement funding efforts already under way in a number of states "to fill the vacuum," Werner said, created by the President's limit on federal funding.

"All this speaks to the fact that there's a groundswell of popular support that started with the scientific and research communities," Werner said. "But the reason why all these members of Congress care is because they are hearing [it] in their town meetings from their constituents."

In contrast to efforts to ease stem cell research restrictions, two other bills on the legislative agenda have been introduced to prohibit all cloning, for research and reproduction. One was written by Sens. Sam Brownback (R-Kan.) and Mary Landrieu (D-La.), and the other is from Reps. Dave Weldon (R-Fla.) and Bart Stupak (D-Mich.). The former has 26 Senate backers, and the latter has 113 supporters in the House.

Should any of the bills make their way to the executive office, Werner said the president has yet to officially indicate whether he is leaning for or against any of them. But he has said that he supports a ban on all cloning, and the administration has given no indication that it would support the Castle-DeGette stem cell funding bill or change its stem cell policy.

"The question is whether the research supporters can generate enough popular and political support that perhaps the president would be willing to compromise," he said. "The president has not vetoed a bill yet, and I think it would be very interesting to see if the first bill he vetoes would be a bill that could provide help to people who are sick."

Drug Import Debate Raises Eyebrows

The issue of drug importation again garnered attention last week when a pair of Republican senators faced off on the matter during a committee hearing.

Sen. Olympia Snowe (R-Maine) and a bipartisan group of fellow senators and others addressed the Senate Health, Education, Labor and Pensions Committee to discuss the Pharmaceutical Market Access and Drug Safety Act of 2005. The bill, which has 31 co-sponsors, is designed to create a regulatory system that would allow Americans to buy cheaper prescription drugs from abroad. Among its supporters is David Kessler, a former commissioner of the FDA and now the dean of the University of California at San Francisco's medical school.

The legislation would allow only FDA-approved drugs made in FDA-inspected facilities to be imported, and commercial importation by pharmacists and wholesalers would be allowed from only a limited number of countries that have regulatory systems comparable to the FDA. Lastly, only pharmacies and drug wholesalers that register with the FDA would be able to import prescription drugs.

But the testimony drew the ire of Sen. Judd Gregg (R-N.H.), who argued that the proposed system would not be safe enough.

Nevertheless, the debate is likely to continue as consumers and many of their representatives fight for efforts to lower drug costs, which last year climbed at double the inflation rate, according to a report recently released by AARP.