FDAnews Quality Training Advisor

GMP Primer: Understanding FDA Enforcement

April 1, 2015
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In last week’s issue, we looked at training employees to understand the FDA’s authority to inspect and cite facilities for GMP violations. This week, we’ll cover the kinds of legal actions the agency can take in cases of serious infractions and threats to public health.

Consent Decree

When the FDA issues a Warning Letters to a manufacturer, it explains the nature of the violations it has found and puts the firm on notice that it must fix the problems to the agency’s satisfaction or face stern punitive actions. (Note: The agency is not required to issue a Warning Letter before taking action.) Failure to do so may result in a court-ordered consent decree.

A consent decree, sometimes known as an Injunction and formally known as a Consent Decree of Permanent Injunction, is an order issued by a judge when the party in violation of the law agrees voluntarily to cease the action without admitting guilt. Such an agreement is legally binding. The FDA uses consent decrees to stop violations of the Food, Drug and Cosmetic Act.

A company is most likely to receive a consent decree if they have not taken the steps to implement a CAPA plan as promised in its response to a Warning Letter or if it has taken an excessive amount of time to complete the plan.

A consent decree usually includes some sort of fine – for instance, reimbursement of inspection costs – a timetable for completing required actions and penalties for failing to comply. If it satisfactorily fulfills all its commitments under the decree, the firm can petition the court to have the decree lifted.

Seizure

If the FDA determines that a product already on the market violates the Food, Drug and Cosmetic Act, it can take possession of the product to keep it from causing public harm.

The FDA petitions a federal court for an order to seize the product. In effect, the agency is accusing the product of breaking the law and asking for an arrest warrant. The seizure is carried out by U.S. Marshals.

Seized products are destroyed, and the manufacturer is prohibited from making and distributing more. Manufacturers can, however, request entering into a Consent Decree under which it will work to bring the offending product into regulatory compliance.

In extreme cases, the FDA can even force closure of the facility.

Debarment

Debarment is a penalty set forth in a 1992 amendment to the Food, Drug and Cosmetic Act.  Debarment can occur when the FDA determines that:

  • An individual or company has been convicted of a felony involving fraud; or
  • Such individual or company has demonstrated a pattern of conduct that gives reason to believe they may violate the law. 

Debarment effectively prohibits a person or company from engaging in work within the industry. 

Disgorgement

The FDA may charge a manufacturer a disgorgement fee for violating the law. Disgorgement generally is based on the profits a company has made on the offending product.  The disgorgement fee is paid to the U.S. Treasury.

Criminal Prosecution

Intentional violators of the Food, Drug and Cosmetic Act can be criminally charged and prosecuted.  The FDA typically will prosecute individuals or companies it feelshave deliberately tried to defraud the public.

An employee committing a criminal act or felony, such as falsification of data, can be criminally prosecuted, jailed and fined.  In addition, management personnel who know about or should have known about this type of fraud are also subject to criminal prosecution, jail time and fines.