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What happens if defective drugs fail to meet FDA standards?


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About a month ago this blog touched on one aspect of the federal Food and Drug Administration’s (FDA) apparatus used to regulate the pharmaceutical industry, its Current Good Manufacturing Standards (CGMPs). Readers may recall that these guidelines govern how companies design manage and control the facilities they use to manufacture the drugs that are so necessary for so many Texas residents to maintain their health. Further, in a separate post, we discussed that when a manufacturer fails to meet these standards, FDA will label drugs produced there ‘adulterated.’ As we pointed out then, this label does not necessarily mean any particular bottle of pills is bad, just that there was some failure in meeting the CGPS in the manufacturing process.

However, what happens if the FDA does detect that there is a problem with a particular drug? For example, what if a particular manufacturing run of a certain medication is ineffective as it contains less of the active ingredient of the medicine than intended? In this case, a person relying on that drug to alleviate potentially debilitating health effects or even keep him or her alive may experience a negative health outcome.

In a case like this, what can the FDA do? Well, what will usually happen is that the agency will request that the manufacturer announce a voluntary recall of the medicine. While the FDA does not have the authority to force a company to recall a drug, most manufacturers will comply, considering potential consequences and liability. If the company does not recall the medication, the FDA will issue a public warning and seize the drug to protect the public.

As can be seen, the FDA does what it can to help ensure the flow of pharmaceuticals to market is safe and reliable. However, given the number of drugs produced every day, and the many different types and formulas, mistakes are bound to happen, and defective drugs may end up in the hands of consumers. Those who are injured by such products, or their family members, may need to avail themselves of the legal system to pursue damages and provide incentive for drug companies to comply with the law.

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