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Science, medicine, and decision making.(GUEST EDITORIAL)
When physicians advise their patients about medications or medical devices, whether prescription or over the counter (OTC), they rely on the information provided on the product labels and package inserts. They trust that information to be reliable and unbiased.
That labeling and insert information is based on the scientific and clinical data provided to the Food and Drug Administration by pharmaceutical and medical device companies and is evaluated for safety and efficacy by FDA medical and scientific staff. This information has a well-deserved reputation for being based on science.
Decisions to approve or deny a product in the first place--even if controversial--also are based on objective analyses by review staff at several levels within the FDA. The scientific staff there is extremely dedicated to the agency's mission to protect and advance public health and is very well qualified to do the job.
Unfortunately, recent actions--not based on science--taken by FDA leadership have put not only the FDA's reputation at risk but also the health of women and their families, by limiting women's access to an important product.
That product, of course, is the Plan B emergency contraceptive. The recent decision to delay granting over-the-counter status to Plan B has limited once again the ability for a woman to prevent an unintended pregnancy and thus, in many cases, to prevent an abortion.
The decision to deny over-the-counter status until the FDA finished its deliberations was made despite the fact that every level of review within FDA's Center for Drug Evaluation and Research (CDER) and its outside advisory committee recommended approval. Although FDA does not always agree with its outside advisory committees, it is rare that it has disregarded both the advisory committees and the FDA professional staff.
Plan B emergency contraception has now been denied approval for over-the-counter marketing twice. The ...
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...The U.S. Food and Drug Administration (FDA) has asked the Inspector General of the...concerns involving a clinical trial that FDA itself sponsored. The trial, named "Bone...Army. The principal investigator is an FDA employee, and the coprincipal investigator...
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Source: HighBeam Research, Science, medicine, and decision making.(GUEST EDITORIAL)