When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively delaying a response will not make it go away, the ramifications will only increase.
The Rationale
The consent decree term is not limited to activities associated with the FDA. It is an agreement, approved by the court, pursuant to which the defendant ceases activities alleged by the government to be illegal and the government’s action is dropped, especially in antitrust and other regulatory matters. The document is signed by the responsible executive at the firm, the U.S. Attorney and a US District Court.
It is essentially a court order that describes the conditions under which manufacturing can occur under close scrutiny by a third party and or the FDA. Depending upon the agreement, the company may be required to discontinue production. In other cases once manufactured, the product must be reviewed by a third party. The cost for this outside review is paid by the company.
Consent decrees cover a broad range of issues that represent a pattern of non-compliance to the regulations. There may be repeated 483s during inspections or warning letters with unsatisfactory responses. This is important as a company may be communicating with the FDA during this time however the plan to correct the deficiencies is not acceptable.
It may take several years to satisfy the agreement. During this time, corrections must be executed to bring the processes back into compliance. The company can make changes to their quality system in order to avoid litigation. Timelines are critical as missing a commitment may lead to fines. The fines, the dollars necessary to bring a facility up to standards, the loss of revenue if product cannot be sold and any third party resources can cause the total cost to skyrocket.
When a company does not respond or comply with the FDA, the agency then can request the Justice Department to file criminal charges. A company is notified of the charges either through a subpoena to provide records or other information or when federal agents execute a search warrant at offices or other company facilities.
The Tipping Point
There is a term for the consent decree called sign or sue. Either agree to hand over control of some of your operations or enter into litigation. The investigation looks for evidence of fraud, concealment of information, obstruction, repeat violations, the severity of the violations and risk to public safety. Prosecutors will review this evidence and determine whether to proceed with further litigation.
Enforcement Journey
The noncompliance road does not happen overnight but may be inherent in the corporate culture and increasing pressure to meet the bottom line. Companies directing fewer resources into manufacturing improvements and quality systems may be the cause. Prosecution hopes to send a message to any of the FDA regulated industries that they may be next. The FDA offers companies opportunities to correct violations. Litigation typically occurs only in the most severe cases.