FDA Rolls Out a New Form—You May Want to Pay Attention to This One

By JP Ellison & Wes Siegner –

There are 12 pages of FDA forms on the FDA website covering everything from product topics (foods, drugs, cosmetics, etc.) to safety forms and FDA field operations forms.  Unless we missed it, one of FDA’s newest forms isn’t on its website.  It’s a form that FDA’s Office of Criminal Investigation (OCI) has apparently begun using in connection with investigations of  drug sales and distribution in the U.S.  As we understand it, OCI’s new “Acknowledgment” form is presented by OCI special agents who personally visit establishments, advise the operators to immediately stop allegedly illegal conduct and request that a responsible person sign the form, which is then co-signed by the special agent.

It is not clear how or why FDA OCI agents are using this form; and to date, our attempts to learn more have not been successful. Nor do we have any sense of how this form relates to FDA’s Regulatory Procedures Manual, Investigations Operations Manual, or its unapproved drug guidance.  We speculate that OCI may be using this form in an attempt to quickly shut down distribution of allegedly  illegal drug sales by drug establishments in situations where OCI does not believe that the persons or entities at the establishment are distributing the products with knowledge that they are “illegal.” Our advice to anyone presented with this form, or any other FDA form; such as “FDA Affidavits,” which are routinely presented in the context of FDA inspections, is to consult with counsel.  By way of example only, the Acknowledgment form asserts that entities and individuals that received adulterated and misbranded drugs, or delivered such drugs violate the laws, can face criminal penalties.  The form omits any discussion of Section 303(c) of the Act (21 U.S.C. 333(c)), which specifically states that the penalties of section 303(a)(1) of the Act (21 U.S.C. 333(a)(1)) do not apply in certain circumstances. While one can understand why OCI might want to utilize such a form to achieve “voluntary” compliance, regulated persons and entities should think carefully about the consequences of signing this form.