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How to Protect Consumers from Dangers of Unapproved Drugs

Each year, doctors write millions of prescriptions for unapproved drugs, often without even knowing it. 

These drugs have never been subjected to the rigorous approval process of the Food and Drug Administration (FDA), and as a result the patients who use them are unknowingly exposed to serious risks that can be harmful - or even deadly. 

These risks include adverse side effects that often result from a general lack of information regarding the intended and safe usage, which includes proper regiment, dosage and possible drug to drug interactions.  In fact, countless injuries and hundreds of deaths have been associated with the use of unapproved drugs.

I find this unnecessary threat to patients deeply concerning, which is why the National Minority Quality Forum (the Forum) began a comprehensive effort earlier this year to educate patients, providers and the general public about the inherent dangers of using unapproved drugs when there are FDA tested and approved versions available.  We at the Forum believe that those who are responsible for making unapproved drugs available to the unknowing public should be made aware of the potential and unnecessary harm to patients that could result from their actions.  We believe that it is critically important that patients and healthcare providers recognize the potential dangers of prescribing and taking drugs that have not met the FDA's rigorous standards for safety and effectiveness.  And we strongly believe that the best way to mitigate the potential for harm is for patients to use FDA approved drugs when possible.

The FDA has been active in helping us to achieve this important goal. The Agency's Unapproved Drugs Initiative, announced in 2006, calls for the removal of unapproved drugs from the marketplace and recently, the agency has recently accelerated its efforts to act on this initiative.  And to date, over 500 untested products have been successfully cleared from the market through this program - making our pharmacies safer for patients across the country.  This is a great start, but with unapproved drugs accounting for 2% of the total drug marketplace in the United States, there is still much work to do.

The proactive approach that the FDA is taking to protect American consumers from avoidable harm is impressive and we applaud these efforts.  But everyone touched by this situation must play a role in resolving the problem.  Therefore, it is important that doctors are always aware of whether the drugs they are prescribing to patients have been approved - and that they prescribe FDA approved drugs when possible.  In addition, patients should ask their doctor and pharmacist whether their prescribed medication is FDA-approved.  Finally, we at the Forum are committed to working to encourage manufacturers of unapproved drugs to come forward and submit their products to the FDA. 

Working together, we can take the necessary steps to protect consumers from the dangers of unapproved drugs.


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