The FDA's Role

How many times have you sought a prescription only to find it has not been FDA-approved and isn’t covered by your insurance? Who are the FDA and what do they do? A better understanding of the FDA will remove the mystery of this government agency.

Although small in size, the mission of the FDA is to protect all consumers in the United States with a broad umbrella of safeguards that enables them to go about their daily business without worries about the safety of the myriad of products that the FDA regulates. FDA is determined to keep these public health protections what they have always been: an effective armor against public health hazards.

The goods whose standards are set by FDA’s scientists and enforced by the agency’s regulators include all food except for meat and poultry, all prescription and non-prescription drugs, all blood products, vaccines, tissues for transplantation, all medical equipment and all devices that emit radiation including microwave ovens, all animal drugs and feed, and even all cosmetics. New products that are designed to treat human conditions or diseases are examined by FDA’s reviewers for safety and effectiveness before they can be made available to consumers.

Moreover, FDA inspectors and scientists ensure the safety and wholesomeness of 75 percent of all foods consumed in the United States, and the agency is responsible for products’ labeling, which must be truthful and not misleading. The FDA also protects women by making sure that all mammograms performed in the United States are of the highest quality. To protect senior citizens, the agency finds and brings to court those responsible for bogus medicines on the market.

How long does something take to be approved by the FDA? Before Congress passed the Prescription Drug User Fee Act of 1992, it took the agency an average of 30 months to clear a medication for public consumption. But after the act was implemented, the agency was able to hire additional reviewers and support staff who have helped reduce the median review time for drugs to 12 months; and for priority applications for products offering a significant therapeutic advance, the median time for approval has been cut to six months.

The FDA has plans for the future to ensure the safety of the population. These plans include improvement of the diagnostic tests for the nation’s blood supply, enhancement of the quality and accuracy of clinical trial designs so that firms can bring new drugs to patients faster and more cost-effectively, and new methods to detect food contaminants to counter the emergence of previously unknown foodborne pathogens like mad cow disease.

So now, when you as caregiver or senior citizen read about or hear about a new drug that has not yet been approved by the FDA, you know that this means that the time it takes to hit the market, if approved, can be anytime from six months to a year; perhaps not as long as you expected.
 

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