Washington Editor

WASHINGTON - In response to their belief that President Bush's stem cell policy has hindered the progress of science, Reps. Diana DeGette and Mike Castle introduced legislation to strengthen federal support for embryonic stem cell research.

DeGette's (D-Colo.) office said the legislation would expand research eligible for funding, increase participation from scientists at the National Institutes of Health in Bethesda, Md., and establish strict ethical guidelines for the research.

"This will allow stem cell research to move forward at a pace determined by science, not limited by government," DeGette said.

President Bush's policy to limit federal funding to 78 human embryonic stem cell (ESC) lines that were available Aug. 9, 2001 - the day the policy was announced - has been the target of unending criticism. In the years since the policy was implemented, researchers have complained that some lines are not viable or accessible.

Many scientists believe that ESC research holds the key to discovering treatments for Alzheimer's disease, Parkinson's disease, heart disease, diabetes and multiple sclerosis. Others say there are alternative approaches and therapies that abrogate the need for human ESC research.

But Bush has held his ground, even after former first lady Nancy Reagan called for an expansion of such research following the death of former President Ronald Reagan, who suffered from Alzheimer's disease.

In a recent letter to DeGette and Castle (R-Del.), NIH Director Elias Zerhouni "acknowledged the scientific benefit of expanding the [ESC] policy," according to a statement from Castle's office.

Zerhouni's comments were in response to an April 28 letter signed by 206 members of Congress urging the White House to expand the current ESC policy.

Zerhouni said: "And although it is fair to say that from a purely scientific perspective more cell lines may well speed some areas of human embryonic stem cell research, the president's position is still predicated on his belief that taxpayer funds should not sanction or encourage further destruction of human embryos that have at least the potential for life."

Meanwhile, DeGette said the bill she introduced with Castle would enable scientists in the U.S., where stem cells were discovered, to reclaim leadership in the field and enable patients in the U.S. to reap benefits from their advances.

House Committee Seeks To Limit FDA

The House Appropriations Committee last week approved a measure to keep the FDA from enforcing a ban on reimporting prescription drugs from other countries.

While it currently is illegal to reimport drugs, traditionally the FDA has not enforced the policy.

A section of the new Medicare law would legalize reimportation if Health and Human Services Secretary Tommy Thompson certifies that it is safe. However, past attempts at similar routes have been unsuccessful. Former President Bill Clinton had given Donna Shalala, former HHS secretary, the same power, yet she refused to certify the plan's safety.

As a result, legislation to resolve the matter is making its way through both the House and Senate.

In the Senate, Judd Gregg (R-N.H.), chairman of the Senate Committee on Health, Education, Labor and Pensions, introduced separate legislation (referred to as the Safe Importing of Medical Products and Rx Therapies Act) that would allow U.S. citizens to import from Canada now, and from the European Union in three years. That legislation would provide the FDA with money to regulate the program. (See BioWorld Today, June 14, 2004.)

Also in the Senate, legislation that would punish drug companies seeking to protect and control their products by limiting sales to Canadian wholesalers and pharmacies was introduced in April. (See BioWorld Today, April 23, 2004.)

Similar legislation passed in a 243-186 vote in the House last year.

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