WASHINGTON - Another legislative push is under way to improve researchers' access to stem cells.
The Stem Cell Replenishment Act of 2005 recently was referred to the U.S. House of Representatives' Committee on Energy and Commerce, where it was assigned to the subcommittee on health. Sponsored by Rep. Juanita Millender-McDonald (D-Calif.), the bill aims to authorize the use of federal funds for research on human embryonic stem cells, irrespective of the date on which they were derived.
Such a provision, of course, is designed to circumvent Bush administration restrictions that limit federally funded research to cells produced before August 2001. Because of those restrictions, the bill notes that the U.S. "would lag behind and lose its leadership role in scientific achievement and discovery."
Citing diseases that could be better served through stem cell research, such as juvenile diabetes and Parkinson's disease, the proposed bill calls for the National Institutes of Health to review guidelines and notices it has published on human embryonic stem cell research, and revise them to ensure the availability of not less than 60 stem cell lines fit for research. Fresh stem cell colonies would be culled from spare embryos scheduled to be discarded by fertility clinics.
The bill, labeled HR 162, is being co-sponsored by Rep. Danny Davis (D.-Ill.).
FDA Advises Caution On Cephalon Drug
The FDA slapped a bolder warning on Cephalon Inc.'s Gabitril (tiagabine).
The label change is designed to caution prescribers of the risk of seizures in patients without epilepsy being treated with the drug. Although Gabitril has been shown to reduce the frequency of seizures in epilepsy patients, its use has been paradoxically associated with the occurrence of seizures in patients without epilepsy. Gabitril is approved for use only as adjunctive therapy in adults and children 12 years and older for treating partial seizures. Because Gabitril has not been systematically evaluated in adequate and well-controlled trials for any other indication, its safety and effectiveness have not been established for any other use.
The FDA said Cephalon will undertake an educational campaign to discourage Gabitril's off-label use.
The news did not impact the West Chester, Pa.-based company's stock.
Another State Adds Trade Association
Montana has formed a biotech trade association, making it the 39th state with an organization to represent the industry.
Called the Montana BioScience Alliance, it was formed to bring together universities, biotechnology industries, hospital and clinical laboratories from all Montana regions. Its primary role will be to assist in transferring promising technology into the private sector, and to cultivate relationships between the life sciences cluster and state government.
At the same time, Montana joined a number of other state trade associations that make up the Council of State Bioscience Associations, part of the Biotechnology Industry Organization in Washington.