Word: fda
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Dates: during 2000-2009
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...consumers. During those years, every American that could have benefited from the drug—either by having a higher quality of life, or by being alive at all—has not, while her cohorts in less draconian countries have been living better and longer. Every time the FDA approves a new drug, as it just did for Symbicort, a new asthma medication, and touts the drug’s benefits, it ignores that its delay in approving the drug has deprived Americans of those benefits for as long as it spent in the pipeline...
...reported late this summer, has been linked to 10 cases of congestive heart failure. Gleevec has also, as has been less widely reported, been linked to thousands of lives saved. Concerns about “another Vioxx” may be blindly accepted, leading the Food and Drug Administration (FDA) to increase regulation and make it harder for patients to get access to live-saving medication...
...wonderful drug and patients with these diseases need to be on it.” But, in general, recent coverage of the adverse side effects of certain drugs tends to generate calls for more stringent—and thus longer and more expensive—FDA screening...
...constrains the number of drugs companies are willing to develop. If a pharmaceutical company cannot expect to make back their costs—which could reach over $1 billion—in sales from a drug, it will not even go to the trouble of submitting the drug for FDA approval. This limits the options available to those with rare diseases, because the FDA creates a huge disincentive to make drugs that will only help a “niche” market. That explains why we have seen such a large decline in the number of drugs introduced...
...Certain that they are going to die if a treatment for their disease is not made available quickly, terminally ill patients are generally quite willing to try anything that might work, even if the drug is risky. When patients have little to lose, it seems completely unreasonable for the FDA to not even let them try. That may be why the federal appeals court for the D.C. Circuit, the court that hears cases about regulatory agencies, ruled on May 2 that “a terminally ill, mentally competent adult patient’s informed access to potentially life-saving...