How to Avoid Getting a Consent Decree
Not much in the pharmaceutical and regulatory compliance industry brings fear like the words, "consent decree". Together, those two words sound negative – and for good reason. Getting a consent decree from the FDA can be a huge negative for any dietary supplement or pharmaceutical company. Industry experts and investors view the orders as a huge negative in every way.
What is a Consent Decree?
A consent decree is a legal agreement between the FDA and a company that remedies non-compliance on the part of the business. The use of a consent decree is the final step before FDA litigation. Once a consent decree is handed down, the company commits to performing the corrective measures in a timely manner – as set forth in the decree. A third party verifies these measures.
Why a Company Receives One
Companies do not receive consent decrees out of the blue. Items such as compliance audits and warning letter remediation must have been ignored or failed before any type of decree is handed down. Overall, a company may receive this form of regulatory compliance because they have not followed some aspect of the FDA requirements. If a company is compliant, they can avoid a consent decree. The Steps Leading Up to A Consent Decree
Before you receive a decree, your company will be allotted a sequential timeline of events.
The FDA will give a warning when you are found to be non-compliant.
It is up to you to correct the problems the FDA has found.
If your company does not fix all issues, then the FDA will issue further warnings. If a business continually ignores warnings from the FDA and fails to communicate corrective measures over a long period of time, the company will effectively force the FDA to take action in the form of a consent decree.
They only issue these in a last-ditch attempt to avoid litigation. Documenting what you have done and communicating to the FDA helps to avoid a consent decree.
What the FDA Needs to Know
If a company pays attention to the FDA's warning, then the FDA wants to know what actions a company is taking to become compliant. If a company cannot communicate these things to the FDA and show proof of the measures within two years of the warning letter – then the FDA is forced to use more aggressive actions, which usually includes some type of consent decree.
In an innovative industry, understanding risk must be calculated as part of doing business. Ultimately, a business can only push the envelope so far before the FDA issues a consent decree. If you want to prevent getting a consent decree, or have received one and need assistance, contact us. We have experts dedicated to making sure your product is compliant.