Petition for stem cell policy change circulated

A bipartisan group of 206 members of Congress asked President Bush via a petition to rethink the embryonic stem cell policy that is being blamed for damaging cutting-edge research in the United States.

Reps. Diana DeGette (D-CO), Randy Cunningham (R-CA), Michael Castle (R-DE), and Calvin Dooley (D-CA) led the effort.

At issue is the president’s policy limiting federal funding for stem cell research to 78 lines that were available Aug. 9, 2001, the day Bush announced his decision on the subject. (Originally Bush cleared 64 lines; the other 14 were added to the count some months later.) In the years since the policy was implemented, many scientists have complained that some lines are not viable or accessible.

In a prepared statement, the Washington-based Coalition for the Advancement of Medical Research said the lines that qualify for federal funding are not genetically or racially diverse enough to meet research needs.

Furthermore, it might be impossible to develop future therapies with the current lines, since cell lines cultivated in the past were exposed to mouse feeder cells, and might not be acceptable under federal regulations on biological materials drawn from more than one species.

Many scientists argue that therapeutic cloning applications could lead to revolutionary therapies for Alzheimer’s disease, Parkinson’s disease, spinal cord injuries, diabetes, heart disease, and other debilitating conditions. Others say there are alternative approaches and therapies that eliminate the need for human embryonic stem cell research.

Stem cell research moving forward

An upcoming ballot initiative in California may pave a path for that state’s scientists to better direct their stem cell research.

A proposal to allocate $3 billion over 10 years to such research will go before voters in November. If it passes, the bond-backed bill could circumvent current federal limitations on the use of human embryonic stem cells.

Such studies remain limited by government regulations on the number of cell lines currently available for research in the United States. At present, 19 federally sanctioned lines are offered, a figure critics point to as a hindrance to furthering research.

FDA initiative seeks to speed up approvals

Pressure from Congress and the public to gain access to more efficacious, less expensive drugs and biologics has caused the Food and Drug Administration to rethink its role in the drug development process.

Earlier this year, the agency introduced the critical path initiative, a project to create a new generation of performance standards and predictive tools aimed at providing better and quicker results on safety and effectiveness of investigational products.

FDA officials over the last several months have taken the podium at conferences in Washington looking to sell the plan as a positive step for drug companies and recently kicked off its campaign, "The Critical Path, From Concept to Consumer."

Each year, new guidance on different diseases or indications will be issued under the critical care initiative. For example, if an obesity drug were the subject of a critical path, the FDA would provide descriptive guidance about what is expected in the clinical and regulatory process from concept to bedside. Also, the FDA expects to provide scientists, investors, and companies with information on the types of diseases needing new treatments and on research grants available through the National Institutes of Health in Bethesda, MD.

The initiative also calls for the FDA to work with the industry, academia, and other government agencies to develop the "Critical Path Opportunities List," which is designed to identify areas that would most benefit from a modernized path of medical product testing and manufacture.