When is a drug 'safe'?

Article Abstract:

Henry I. Miller of the Office of Biotechnology of the United States Food and Drug Administration (FDA) responds to the criticism that the FDA receives on its handling of issues or specific products. The FDA is criticized at times for being too lenient on regulatory policies or decisions and at other times for being too slow. It is felt that a policy where, as soon as any degree of effectiveness of a product is shown, the FDA should approve it and thus make it available to those who need it, is beneficial to the manufacturer but not necessarily the patient. It is true that any genuine delay of a safe and effective product should be criticized. The FDA also wants products to be quickly approved, as there is a cost of regulatory delays. However, any patient, even those with a fatal disease, can be made worse with an unsafe drug. The costs of time must be weighed against the problems brought on by an unsafe, ineffective product. The FDA's approach is more effective in bringing safe and effective products to the patients than one of approving products based on initial success. Early reports on a new drug are often optimistic, and verification of the studies and their methodologies must be made. The FDA has already approved over 400 biotechnology products, the majority of which are diagnostic test kits, and more than 700 drugs and biologicals are currently being tested in clinical trials. The marketing approval time is on the average 33 months, while biotechnology-derived drugs and biologicals require on the average half that time for approval. The products are not mindlessly put through the same evaluating procedures as was suggested in an article in Nature (v 343, p 494). The FDA is committed to further refining its procedures for drug evaluation. Recent changes should make drugs available sooner and should shorten review times. The FDA's actions must be based only on solid scientific analysis. The approval of an unsafe drug or the delay of a safe and effective drug, can both have disastrous consequences. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Drugs, Testing, Social policy, United States. Food and Drug Administration, Biotechnology

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Biologically erodable microspheres as potential oral drug delivery systems

Article Abstract:

A drug delivery system that adheres to the gut lining will make more efficient the administration of oral drugs. In view of this, the self-assembly of polymer 'microspheres' which can be loaded with various biologically active agents such as DNA or proteins such as insulin is described. These microspheres adhere to the gastrointestinal lining in rats, passing across the gut epithelium, through and between cells, before delivering their contents to the circulation or to adjoining cells. These microspheres thus offer a possible new approach to drug and gene therapy.

Research, Usage, Transdermal drug delivery systems, Microspheres, Bioadhesives, Bioadhesive drug delivery systems

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Reviewer leaked Avandia study to drug firm

Article Abstract:

The controversial issue related to damaging report leaked by a reviewer for The New England Journal of Medicine about the diabetes drug Avandia to the drug's manufacturer is reported. The report yielded broad media attention and decreased the stock price of Avandia's manufacturer, GlaxoSmith Kline by 13%.

Sales, profits & dividends, Product information, Pharmaceutical Preparation Manufacturing, Pharmaceutical preparations, Antidiabetic Preparations, United Kingdom, Pharmaceutical industry, Company sales and earnings, Hypoglycemic agents, Company earnings/profit, Avandia (Medication), GlaxoSmithKline PLC

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