The FDA Cannot Protect Consumers

by Robert Schwartz

The Food and Drug Administration (FDA) announced recently that it had discovered that drug companies were selling prescription cough/cold/allergy drug products that it had not approved as safe and effective. Yes, the drug companies have been selling these products without the approval or blessing of the FDA. These drug companies, as with all prescription drugs sold by both domestic and foreign manufacturers in the United States, are required by federal law to register and list all of their commercially marketed drug products with the FDA (21 U.S.C. § 360 and 21 CFR 207). Amazingly (but not surprisingly), many drug companies do not comply with this very important law. They don’t even update their existing drug listing information with the FDA. Consequently, the FDA often doesn’t even know what drugs these companies are selling at any point in time.

So, when you read or hear that drug regulation needs to be left up to the FDA and not the courts, you are now armed with the knowledge that the FDA cannot and does not receive the information from the drug companies to be able to do this. Remember that in the FDA’s new drug approval process, the information the FDA has and considers in this very important decision comes solely from the drug company that is trying to get its drug approved. That is nothing more than the fox guarding the hen house. Consumers absolutely have to be able to access the judicial system to hold drug companies responsible and accountable for serious injuries caused by these dangerous drugs.

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