We Help Companies in the Food, Drug, Medical Device, and Cosmetic Industries Maintain FDA Compliance
Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Among all of the areas of federal compliance, U.S. Food and Drug Administration (FDA) compliance is perhaps the most unique. While broad rules, regulations, and prohibitions apply across the board, specific and highly technical rules also apply to companies in the food, drug, medical device, and cosmetic industries. With different rules applying to different companies, FDA compliance does not lend itself to a one-size-fits-all approach. To the contrary, companies must adopt tailored compliance programs, and they must continually reassess their compliance obligations and efforts on an ongoing basis.
Is your company subject to the FDA’s oversight? If so, compliance needs to be a priority. The FDA has been cracking down on violators in recent years. Companies that violate the Food, Drug, and Cosmetic Act (FDCA) and the FDA’s regulations can face substantial administrative and civil penalties, and, when warranted, the FDA will not hesitate to refer cases to the U.S. Department of Justice (DOJ) for criminal prosecution.
Understanding Your Company’s FDA Compliance Obligations
FDA compliance means different things to different companies. Understanding this fact is a key first step toward understanding your company’s compliance obligations. From clinical testing to marketing, and from scientific claims to recalls, various aspects of companies’ business operations can implicate the FDA’s oversight based on the types of products they sell.
The FDA does not provide much direct guidance to companies. Instead, it leaves it to companies to properly interpret the FDCA and the Administration’s rules and regulations. This includes (but is not limited to) the rules and regulations addressed in the FDA’s internal guidance to its auditors, inspectors, and agents:
These are dense and complex documents that the FDA uses to assess companies’ compliance efforts; and, as such, they are useful resources for companies as well. Even so, companies must still make judgment calls and strategic decisions regarding FDA compliance. At Corporate Investigation Consulting, our team of consultants brings centuries of relevant experience to the table, and we work closely with our clients to help them identify, understand, and meet their FDA compliance obligations.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
Our FDA Compliance Consulting Services
We provide comprehensive FDA compliance consulting services to companies in all industries subject to the FDA’s oversight. This includes companies in the food, drug, medical device, and cosmetic industries. With deep knowledge of the FDCA, the FDA’s rules and regulations, and their practical implications, our consultants are able to offer strategic, tailored, and cost-effective compliance solutions to our clients.
Our FDA compliance consulting services include:
Application of the FDCA, CPM, CPG, and RPM
We consult with our clients regarding compliance with the FDCA and the applicable CPM, CPG, and RPM. Our consultants work with our clients’ key stakeholders to assess their compliance obligations in light of their operations and products, and we use this assessment to develop custom FDA compliance programs.
Compliance Program Development
Developing an effective FDA compliance program requires an in-depth understanding not only of the business itself, but also of the ways in which the FDA interprets and enforces the laws, rules, and regulations to which the business is subject. Our compliance program development process is all-encompassing, and it involves close collaboration between our consultants and our clients’ key stakeholders. At the end of the process, our clients receive a comprehensive set of policies and procedures that they can use to maintain compliance in all aspects of their operations.
Compliance Program Implementation
In addition to developing our clients’ FDA compliance programs, we also guide our clients through compliance program implementation. This includes providing training materials and programs, changing existing processes and procedures, and establishing new processes and procedures as necessary. Here too, our approach is comprehensive, and is designed to ensure that our clients will be able to affirmatively demonstrate compliance to the FDA when necessary.
FDA Approval Process
For clients that need to seek FDA approval, we provide a full suite of services to help them avoid missteps and secure approval as quickly and cost-effectively as possible. Our consultants have significant experience with the FDA’s ordinary, priority, and fast-track approval processes, including 510(k) clearances.
Sampling, Licensing, and Distribution
Companies subject to the FDA’s oversight frequently run into issues regarding sampling, licensing, and distribution. Maintaining compliance with respect to these business processes is not easy, and there are several common mistakes that get companies into trouble. Our consultants know what the FDA expects from companies regarding sampling, licensing, and distribution, and we help our clients adopt internal controls that facilitate compliance.
Scientific and Marketing Claims
Scientific and marketing claims are also common problem areas for food, drug, medical device, and cosmetic companies. Companies must be extremely careful when making scientific claims in support of their FDA approval applications, and they must exercise equal caution when making claims in their marketing materials. Our consultants help our clients’ marketing and communications teams comply with the law. We also provide assistance with labeling and package inserts so that our clients can avoid recalls and product defect litigation based on inadequate warnings and misleading claims.
Adverse Event Response
Companies subject to the FDA’s oversight must also be extremely careful when dealing with adverse events in order to avoid making mistakes that take their situations from bad to worse. We prepare our clients to respond to adverse events, and, when necessary, we guide our clients through the adverse event response process. This includes dealing with the FDA and other federal authorities on our clients’ behalf.
Compliance Monitoring, Auditing, and Enforcement
To help our clients maintain compliance on an ongoing basis, we also provide services in the areas of monitoring, auditing, and enforcement. This includes internal and external monitoring (i.e., monitoring our clients’ compliance efforts and monitoring for updates to the FDA’s regulations), as well as conducting internal compliance audits and consulting with our clients regarding internal enforcement.
FDA Audit and Inspection Preparedness
Even with effective compliance programs in place, companies can still expect to face FDA scrutiny. When contacted by the FDA, companies must be prepared to affirmatively demonstrate compliance in all aspects of their operations—from maintaining up-to-date compliance policies and procedures to ensuring adequate substantiation of all scientific and marketing claims. We provide our clients with an executable roadmap for dealing with the FDA, and we consult with our clients during FDA audits and inspections as desired.
FAQs: FDA Compliance in the Modern Era
What are some of the most common FDA compliance mistakes?
Companies of all sizes routinely make a variety of mistakes regarding FDA compliance. One of the most common, and most egregious, mistakes we see is failing to adopt sufficiently tailored FDA compliance programs. When it comes to FDA compliance, companies cannot afford to make assumptions, turn a blind eye, or rely on off-the-shelf compliance products. To avoid FDA penalties, they must address their compliance obligations head-on. This applies to everything from how they structure their operations to how they market their products.
How can companies effectively encourage their employees to prioritize FDA compliance?
Establishing a culture of compliance is essential for companies that are subject to the FDA’s oversight. To encourage their employees to prioritize compliance, companies can take a top-down approach that demonstrates a commitment to compliance at the highest levels of the organization. Providing adequate training is essential as well, and companies must carefully balance rewarding compliance with disciplining compliance failures.
How does the FDA uncover companies’ compliance violations?
The FDA uncovers companies’ compliance violations through several different means. Along with audits and inspections, the FDA also relies heavily on consumer complaints, reports from health care providers and pharmacies, and referrals from other federal agencies.
What are the risks of failing to maintain FDA compliance?
The risks of failing to maintain FDA compliance can be substantial. From a purely commercial perspective, noncompliance can necessitate recalls—which can in turn cause significant harm to companies’ reputations (in addition to the potential for litigation). However, FDA compliance failures can also lead to fines, loss of approval, additional oversight, and even criminal prosecution in some cases.
What should I look for in an FDA compliance consulting firm?
There are several factors to consider when choosing an FDA compliance consulting firm. Relevant experience is a critical factor, as understanding and addressing companies’ compliance obligations requires in-depth familiarity with the FDA’s rules, regulations, processes, and procedures. As companies that are subject to the FDA’s oversight will generally have a broad range of other compliance obligations as well, it is also important for most companies to choose a firm that has the ability to provide comprehensive compliance services.
Schedule a Complimentary Consultation with an FDA Compliance Consultant
If you would like to speak with a consultant at Corporate Investigation Consulting about your company’s FDA compliance obligations, we encourage you to get in touch. To schedule a complimentary consultation at your convenience, please call 866-352-9324 or tell us what we can do to help online today.