Are There Loopholes in the Way the FDA Works

The Food and Drug Administration plays a vital role in daily lives, being the federal US agency that promotes and protects the health of the public by regulating safety standards in food, medical devices, pharmaceuticals and a range of other products.

Its role in the pharmaceutical industry alone is massive, as up to 70 per cent of the American population takes some kind of prescription medicine once a month. The market for prescription meds is huge, with 2014 sales in excess of $374 billion.

Evading Evaluation

The FDA is known for its thorough and careful procedures for evaluating new drugs, which can take some time. However, there are legal loopholes that could allow the unscrupulous to put members of the public at risk. There are also areas in which the FDA could be more active, such as in personal care items, as reported in The Guardian.

The size of the loophole is estimated to be large enough to allow many tens of thousands of drugs that have not been approved onto the market. The National Library of Medicine, which keeps track of unapproved drugs, lists 88,212 medications that have been brought to the attention of the FDA. A tiny proportion of these medications had been throughly evaluated or approved.


After safety issues were identified, some of these drugs were taken off the market, but more than 86,000 remained. It is believed the lapses that allowed these drugs to remain on the market began when the FDA came into being in 1906.

The FDA said in 2013 that it would still give National Drug Code (NDC) numbers to medicines that had not been approved for a particular use. It appears that the FDA may be overwhelmed by the difficulty and expense of evaluating so many pharmaceutical products.

If you are considering engaging companies to help with FDA 510k then it would be worthwhile consulting experts such as FDA third party review.

The actual total of unapproved drugs on the American market is not known. The public only tends to take an interest in FDA processes when something goes badly wrong, such as when Merck’s Vioxx had to be taken off pharmaceutical shelves when deaths from cardiovascular causes rose by an unexpected 50,000 people.


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