Good Communication With FDA Can Limit Enforcement Actions

When responding to lists of inspectional observations (FDA Form 483s) and Warning Letters, companies should address not only the specific issues cited by the FDA but also the broader, systemic considerations that may have led to the alleged problems in the first place, according to regulatory experts who spoke at a recent session of the Parenteral Drug Association/FDA Joint Regulatory Conference in Washington, D.C. In taking this opportunity to communicate fully with the FDA, companies may be able to prevent further FDA enforcement action.

"The most important thing to understand is [that] escalation is not inevitable," said William Vodra, a partner in the Washington, D.C., law firm Arnold & Porter, who has helped to negotiate six consent decrees with the FDA.

The FDA may be reluctant to pursue potentially time-consuming and expensive enforcement action, but it will do so unless it is convinced that companies are taking its concerns seriously. A company's goal "is to convince FDA that further escalation is not necessary," Vodra said, by "trying to convey the notion ... that the company 'gets it'," and taking steps from the outset to address the root causes that may have led to deficiencies cited by the FDA in its 483s or Warning Letters.