Here are some current short healthcare news for your quick update:
• Doctors to FDA: No Cold Medicines for Kids
• FDA to Apply GIVE to Hasten Generic Drug Approval
• HUGO to Sets Up HQ in Singapore
• Dry Powder Inhalers Often Misused: Study
• Doctors to FDA: No Cold Medicines for Kids
Following several high profile voluntary withdrawal of children's cold medicine in the USA, expert advisers to the FDA began a 2-day meeting to consider a petition from paediatricians on the use of cold medicines for children. In a statement, the physicians say OTC cold medicines should not be used in children under 6 because they are ineffective and unsafe. The drug industry maintains the commonly used medicines are safe but can lead to overdoses when misused in infants. The FDA has yet to act on the petition. The controversies continue and on 30-Oct-07, our HSA has issued a Dear Healthcare Professional letter on this which PSS has already distributed to all our members through email blast.
• FDA Applies "GIVE" to Hasten Generic Drug Approval
The US FDA has outlined a programme called Genric Initiative for Value and Efficiency, or GIVE. This is aimed at enhancing the accessibility of generic drug products, both to the consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices.
The GIVE programme will help the FDA modernize and streamline its generic drug approval process. The FDA approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.
FDA now has about 215 full-time staff working on the review of generic drug applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from other FDA departments will be engaged in the effort. As well, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and webcasts.
Generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug are equivalent to the original proprietary product. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.
• HUGO to Sets Up HQ in Singapore
Human Genome Organisation (HUGO), an international organization of scientists involved in human genetics, will move its headquarters from London to Singapore. In Singapore, HUGO’s headquarters will be based at Biopolis, the campus of Genome Institute of Singapore (GIS) and the other biomedical research institutes under Agency for Science, Technology and Research (A*STAR).
Under the new president, Dr Edison Liu, the HUGO, established in 1989 to promote and sustain international collaboration in the study of genes in health and disease, will now focus on two areas. First is to explore and enhance the field of genomic medicine. This means using powerful genomic technologies in medical practice. That transition is not a simple one and will require much thought and wisdom.
The second focus will be on enhancing genomic sciences in the emerging and developing countries of the world. Genomic approaches to disease, pathogens, and the environment can help these countries advance. However, one of the first initiatives on Dr Liu’s agenda for HUGO is a formal study of the impact of genomic medicine on global health.
Elected to the three-year post by the unanimous vote of HUGO’s 18-member council, Dr Liu continues to head GIS, where he integrated genomic sciences with cell and medical biology in order to accelerate the labs’ discoveries. In the GIS, he also heads a robust laboratory program in cancer genomics. Dr Liu’s research is widely credited with markedly improving scientific understanding of the molecular biology of breast cancer and the potential therapeutic relevance of the mutations that have been detected in cancer-associated genes.
• Dry Powder Inhalers Often Misused: Study
New research shows patients often misuse dry powder inhalers used to deliver medication for asthma or chronic obstructive pulmonary disease (COPD). The study found 32% of all users made errors when demonstrating how they used their inhalers, with most errors found among patients over the age of 60 or with the most severe airway obstruction. Researchers recommend that doctors provide proper training of patients on how to use dry powder inhalers.
As Reported by CBS News / WebMD
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