How Binding Are the FDA Guidance Documents? DOJ Says, Not Much
[Posted on: Thursday, March 22, 2018] Earlier this year, the Associate Attorney General at the Department of Justice (DOJ) instructed its staff to not initiate civil enforcement action against any party based on Guidance Documents, a decision that can have an enormous impact on the FDA regulated industry. There are 4220 Guidance Documents available on FDA’s web site; more than a hundred are being drafted. For the last several years, FDA has published more than 100 new Guidance Documents each year, and expects affected companies to follow them. FDA has used its Guidance Documents to not just clarify the regulations it enforces but to add conditions that are not explicitly written in the law. When reviewing the regulations and Guidance Documents, companies often find stricter interpretation of the regulations adding to the burden of compliance. It seems the DOJ agrees that Guidance Documents are not intended to add new rules but only to clarify, explain or elaborate the rules that exist. Ironically, each Guidance Document carries an unequivocal disclaimer at the beginning of the documents stating that the advice provided “is not binding on FDA or the public” and that companies “can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations”. However, frequently, the Guidance Documents are cited by the FDA in meetings with the stakeholders, in making requests of additional information not clearly required in the regulations, and to take administrative and enforcement actions. So, although legally not binding, over the last 2 decades, these documents have become “binding’ for all practical intents and purposes. There is no doubt that Guidance Documents play a critical role in educating the stakeholders about the existing laws, are useful for productive discussions with the FDA reviewers, and save FDA’s resources by not having to repeat the same advice to multiple companies. But it should not be used to create new rules. In cases where the Guidance Documents extends on the rule and are used to take enforcement action, DOJ will not side with the FDA. This would add the burden on FDA to present a clear violation of the regulations, as written, and would not allow citing a given Guidance Document. The biggest impact of this policy will be on areas where FDA has hesitated to create rules due to controversial topics such as autologous stem cell clinics, medical foods, or low risk (Class I and II) medical devices. That said, it should be noted that the DOJ policy does to prohibit FDA from taking administrative actions against companies. FDA still can interpret the regulations any way it sees fit and disagree with a regulated company’s interpretation, and take administrative actions such as not approving a market approval application, canceling the registration, not issuing an import/export license, etc. So, don’t start ignoring the Guidance Documents but use them as a starting point to negotiate with FDA for an alternative approach to meet the requirements of the applicable regulations. If it gets to litigation, companies would have an upper hand, if they can convince the DOJ that the alleged violations cited by the FDA are based on Guidance Documents and not the regulations.
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