The FDA mission is to protect the public with regard to food, drugs and cosmetics. In the 1990’s the FDA added the regulation of medical devices. The FDA does not do any clinical studies nor write any labeling—it reviews paperwork. In the past the FDA advocated to limit patients’ right to seek compensation for harm caused by medical devices, thereby advocating for immunity for medical device manufacturers and limiting notice of harm to the FDA. Some argue the FDA can be politically influenced, and others argue the FDA sees manufacturers as its customers, rather than the public.
The FDA has a poor track record of monitoring drugs and devices post-approval, and often learns of dangers after many patients are injured. As many as 90-95% of medical devices are released for marketing with limited review, based on a comparison to existing devices, even when existing devices are known to cause harm. The FDA does not review nor approve “procedures”, such as refractive surgery; and merely reviews the paperwork provided by the manufacturers seeking approval of the devices intended for use in the “procedures”. Cosmetics and the ingredients in cosmetics are not reviewed by the FDA before marketing, and cosmetics may contain asbestos or other cancer causing chemicals; yet, have no warnings or labels regarding carcinogenic ingredients or the danger of eye make-up.
The FDA does not protect us in the way most people believe, particularly with regard to medical devices and cosmetics. Buyer beware (patients and doctors) before relying solely on the FDA!
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