What Actions Can Be Taken by the FDA Against Pharmaceutical Companies?

During an inspection of a pharmaceutical company by the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) investigators may observe conditions they deem to be objectionable.  The FDA does not need to find a defective tablet, nor does a death nor sickness have to develop.  The FDA does not even have to hear of a complaint.

Objectionable Condition

 

These observations, are listed on an FDA Form 483.  An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD and C) Act and related Acts.  The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. 

Pharmaceutical companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.  The FDA can issue a Form 483 if Good Manufacturing Processes (GMP) are not followed. 

Warning Letter

 

The FDA can take the following actions during a faulty inspection of a pharmaceutical company.  First they can issue a warning letter.

There are three types of Warning Letters on the FDA Website:

• General FDA Warning Letters
• Tobacco Retailer Warning Letters
• Drug Marketing and Advertising Warning Letters

Next a seizure of goods or the offending drug(s).  If there is concern that the product will be distributed before seizure can be effected, FDA will determine if the dealer will voluntarily hold the product or if an embargo will be necessary.  The FDA uses the terms “mass” and “open-ended” to distinguish these seizures from “lot-specific seizures,” in which a specific lot or batch of a product is seized.

Injunction

 

An injunction is a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. Once a complaint for injunction is filed by the United States, a hearing may be placed on the court calendar at any time, this court time could even take place with extremely short notice.

When an injunction is granted, FDA has a continuing duty to monitor the injunction and to advise the court if the defendants fail to obey the terms of the official order or decree.  Should the decree be violated, the agency must consider a civil or criminal contempt of court, or other regulatory action, in as timely a manner as used in initiating the injunction. It is, therefore, mandatory that FDA personnel responsible for initiating injunctions also adhere to the implementation procedure in “Compliance Follow-up."

Debarment

 

The last step is debarment.  Under its statutory debarment authority, the agency (FDA) may also ban, or “debar” from the drug industry individuals and companies convicted of certain felonies or misdemeanors related to drug products. Once individuals have been subjected to “debarment,” they may no longer work for anyone with an approved or pending drug product application at FDA. Debarred companies may no longer submit abbreviated drug applications.

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