CHEMICAL PRODUCT DEVELOPMENT AND DEFENSE

The Acta Group, L.L.C.’s FDA Practice

The Acta Group, L.L.C. (Acta) maintains a diverse food, drug, and cosmetic practice.  The jurisdiction of the U.S. Food and Drug Administration (FDA) extends to a wide variety of professional and consumer products, including:

• Food and food additives
• Medical devices
• In vitro diagnostics
• Prescription and over-the-counter drugs
• Biologics
• Dietary supplements
• Cosmetics
• Animal drugs and feed

Acta professionals have experience with the regulatory requirements for all of these products.

Overview

FDA requirements vary from product to product, so the crucial first step is establishing the appropriate regulatory pathway for bringing a product to market.  All FDA-regulated products involve some form of approval, concurrence to market, compliance with standards or monographs usually contained in regulations, or qualification for a stated exception from the need for clearance.  In addition, FDA regulates the labeling and marketing claims for most of these products.

Acta business and scientific professionals assist clients with strategic planning, counseling on the regulatory requirements applicable to client product lines, and developing pathways to expedite approval of marketing applications.  Our professionals will advise on the preparation of submissions, accompany clients to meetings with FDA when appropriate, and help prosecute the approval of applications when filed.  In addition, Acta professionals help clients plan and implement marketing programs in compliance with FDA requirements.  Our professionals also assist with the design and implementation of manufacturing and quality assurance procedures necessary for most products regulated by FDA and provide clients with guidance on the requirements for importing and exporting regulated products.

Specialized Practice Areas

Many of Acta’s business and scientific professionals are highly skilled in various aspects of chemical and product-specific regulatory and enforcement-related activities invited by the joint regulation of some products, like certain antimicrobials, by the U.S. Environmental Protection Agency (EPA) and FDA.  Some of the issues we address include the following:

• Materials Used in Applications Making Contact with Food Surfaces -- This is a challenging area, particularly when the substance in question is an antimicrobial regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that is added to the product in question as a materials preservative.  Such an application raises thorny questions of FDA/EPA jurisdiction.  The extensive experience of Acta professionals in dealing with FIFRA issues before EPA is available to augment the FDA professionals in addressing these matters efficiently and effectively.

• Antimicrobials Added to Drug or Device Products -- Acta’s multidisciplinary team of experts is well versed in addressing approval and/or registration issues, concerns about the possibility of antimicrobial resistance, and the affect this and other complex issues may have on approvals.  In addition, Acta professionals have considerable experience in navigating the complicated nature of substantiating antimicrobial claims in accord with FDA and the Federal Trade Commission (FTC) standards.

Acta professionals have extensive experience assisting clients in obtaining appropriate authority to market food-contact substances (FCS).  An FCS is “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.”

The Food Contact Notification (FCN) process replaces, in most instances, the time consuming and expensive petition process for authorizing new uses of food additives that are FCS.  Acta professionals, which include in-house polymer chemists and other scientists, assist clients in determining whether an FCN should be filed and how best to prepare the submission to FDA’s Center for Food Safety and Applied Nutrition (CFSAN). 

There are several situations where a proposed use does not meet the definition of an FCS, where CFSAN does not regard a substance in use as an FCS, or where the proposed use is exempted.  Acta routinely assists clients in analyzing, preparing, and defending an appropriate regulatory pathway for such substances, including determining the product is Generally Recognized as Safe (GRAS) or exempted on the basis of the fact that any migration is below the Threshold of Regulation (TOR).

If submission of an FCN is necessary, Acta professionals help clients determine the needed testing and assist in the preparation of a draft document to facilitate a Pre-Notification Consultation (PNC) with CFSAN.

Acta professionals are also highly experienced in the area of medical device matters.  We assist clients on a wide range of areas, including:

• Determination of the regulatory status of the proposed product;
• Preparation of the necessary application when one is required;
• Following the application through the system and assisting the client in responding to questions raised by reviewers;
• Organizing and attending meetings with FDA and the client when appropriate;
• Implementing Good Manufacturing Practice (GMP) systems, focusing on complaint handling systems and on regulations regarding device adverse experience reporting;
• Compliance with the quality systems regulations, and requirements applicable to promotion, with a focus on issues relating to alleged off-label use; and
• Defending medical device products before FDA in all compliance matters, including product recall, FDA inspection practices and related compliance and enforcement sensitivities.

Acta’s professionals have extensive experience in assisting clients with products regulated by FDA as prescription or over-the-counter (OTC) drugs.  Representative issues handled by Acta’s professionals include:

• Advising clients on development of claims, labeling, and promotional materials, including websites, social networking, and clinical medical education (CME);
• Managing compliance risks and promotional violations, including FDA inspections, responding to deficiencies and warning letters, conducting recalls, and coordinating press and media relations;
• Developing corporate policy and training client personnel on promotion, CME, direct sales, and other compliance matters;
• Counseling clients on life-cycle management strategies using patent and non-patent (Hatch-Waxman) options, including seeking orphan drug designation;
• Petitioning FDA on a variety of issues;
• Conducting due diligence and offering regulatory opinions in connection with financing and corporate transactions;
• Guiding clients with food, dietary supplement, and cosmetic products to market through appropriate regulatory pathways; and
• Representing clients before other agencies, including the Consumer Product Safety Commission and the FTC, for products with multi-jurisdictional issues.

Acta often partners with its legal affiliate, Bergeson & Campbell, P.C. (B&C).  B&C professionals bring legal expertise to strategic planning, product approvals, and advocacy.  Acta business and scientific professionals, and B&C legal professionals, are expert in developing approval applications, moving them along through the approval process, and managing the process efficiently when jurisdictional issues involving EPA and FDA arise.  For more information on B&C’s capabilities and professionals, please visit http://www.lawbc.com.