FDA GCP Compliance

Compliance with the FDA’s Good Clinical Practice (GCP) Regulations is Essential for Laboratories, Sponsors, Review Boards, and Other Entities Conducting Clinical Trials

**Attorney Nick Oberheiden**
FDA GLP Compliance Team Lead

**Attorney Lynette Byrd**
FDA GLP Compliance Team Lead
Former DOJ Attorney

Attorney John Sellers — **John W. Sellers**
FDA GLP Compliance Team Lead
Former Senior DOJ Trial Attorney

The U.S. Food and Drug Administration (FDA) enforces strict compliance with the good clinical practice (GCP) regulations for clinical trials. The GCP regulations serve as the clinical trial quality standards and apply to “scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices,” and conducting GCP-compliant trials is an essential step toward securing FDA approval for many types of medical and veterinary products.For NIH funded clinical trials, training is required on protections for studies that involve human research participants.

But GCP compliance presents a variety of challenges. The GCP regulations are long, dense, and complex, and different requirements (and prohibitions) can apply in different circumstances. As a result, an informed approach to compliance is key, and laboratories, sponsors, review boards, and other entities must ensure that they are doing everything necessary to enable themselves to withstand FDA scrutiny if necessary.

Important Information About FDA GCP Compliance for Clinical Trials

With this in mind, what do owners, executives, board members, investigators, and others need to know about FDA GCP compliance? Here are some key insights:

1. The FDA Takes GCP Compliance Very Seriously

The first thing to know is that the FDA takes GCP compliance very seriously. It views GCP compliance as fundamental to ensuring the safety of study participants, patients (both human and veterinary), and the U.S. population at large. As the FDA explains:

“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected . . . and that the clinical trial data are credible.”

This means that entities that are subject to the GCP regulations need to prioritize compliance. When developing clinical trials, laboratories and other entities should do so with the GCP regulations in mind, and they should build study processes, protocols, and procedures around both the GCP regulations’ requirements and the FDA’s expectations. Doing so helps to ensure not only that studies comply with the GCP regulations, but also that laboratories and other entities will be prepared to affirmatively demonstrate GCP compliance to the FDA in the event of an inspection, investigation, or other inquiry.

2. There Are Several Aspects of FDA GCP Compliance

The GCP regulations are not a distinct body of federal regulations, but instead a collection of regulations that exist in various “Parts” throughout Chapter 21 of the Code of Federal Regulations (CFR). As a result, there are several aspects to FDA GCP compliance, and laboratories and other entities must determine which specific regulations apply based on the types of clinical trials they are conducting.

With that said, laboratories and other entities can expect to address multiple GCP regulations in connection with each clinical trial they conduct. To facilitate the efficient management of FDA GCP compliance on an ongoing basis, laboratories and other entities will typically implement policies and procedures designed to ensure compliance as a matter of course—rather than taking a study-by-study approach. These policies and procedures will need to address some (if not all) of the following:

There are also GCP regulations that are specific to Institutional Review Boards (21 CFR Part 56), and there is an entirely different set of regulations that applies to nonclinical trials that do not involve human subjects (21 CFR Part 58). At Oberheiden P.C., our FDA compliance lawyers and consultants work closely with our clients to identify their specific regulatory obligations and help them implement effective and custom-tailored FDA GCP compliance programs.

3. Special GCP Requirements Apply in Some Cases

Along with the GCP regulations listed above, special GCP requirements also apply in some cases. This further adds to the challenges of developing and implementing an effective FDA GCP compliance program.

For example, the FDA has adopted regulations that apply specifically to informed consent in in vitro diagnostic device studies. Notably, while the FDA has stated that it will exercise “enforcement discretion” when deciding whether (and to what extent) to penalize entities for noncompliance with these regulations, it also clearly states that this enforcement discretion, “does not apply to other good clinical practice (GCP) requirements, including IRB requirements under 21 CFR Part 56.”

4. FDA GCP Compliance Requires a Comprehensive and Custom-Tailored Approach

In light of the scope of the GCP regulations and the variations that can exist between different entities’ compliance obligations, a comprehensive and custom-tailored approach to FDA GCP compliance is critical. Laboratories, IRBs, sponsors, and other entities must work closely with experienced legal counsel to ensure that they are doing everything necessary to maintain strict compliance on an ongoing basis.

Once we work with a client to determine the specific GCP requirements that apply to its clinical trial practices and activities, we then shift our focus to drafting policies and procedures that our client can implement effectively in all relevant areas of its operations. We provide assistance with implementation and training as well; and, when desired, we continue to work with our clients on an ongoing basis to ensure that they adhere to their policies and procedures and that they have the documentation they need to affirmatively demonstrate compliance to the FDA.

5. FDA GCP Compliance Is Necessary, But Not Sufficient on Its Own

While FDA GCP compliance is necessary for entities that conduct clinical trials, it is not sufficient on its own. From the Food, Drug, and Cosmetic Act (FD&C Act) to the FDA’s regulations that apply specifically to drugs, medical devices, and other regulated products, these entities may need to meet a variety of other compliance requirements as well.

With a team that includes former federal prosecutors and former FDA personnel, we are well-versed in all aspects of FDA compliance. We provide full-service compliance representation for entities of all sizes, and we can custom-tailor a compliance solution to your organization’s specific risks and needs.

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: How to Effectively Manage FDA GCP Compliance

When is FDA GCP Compliance Required?

FDA GCP compliance is required for all clinical trials falling within the FDA’s enforcement jurisdiction that involve human subjects. This includes (but is not limited to) clinical trials for drugs, medical devices, and other FDA-regulated products. Laboratories, institutional review boards, and other entities must fully address FDA GCP compliance at the outset of the clinical trial process, as they must be able to demonstrate full compliance at all stages of the process when called upon to do so by the FDA.

What Are the Consequences of Failing to Maintain FDA GCP Compliance?

The consequences of failing to maintain FDA GCP compliance can be substantial. Not only can noncompliance lead to non-approval of new pre-market submissions, but it can also lead to civil monetary penalties (CMP) and other penalties imposed directly by the FDA. The FDA can also engage the U.S. Department of Justice (DOJ) to pursue enforcement action when warranted, and noncompliance will frequently have commercial liability implications for laboratories and other entities as well.

Is It Possible to Obtain FDA Approval Without Meeting the GCP Requirements?

While GCP compliance is not required for nonclinical laboratory studies, it is mandatory for all clinical trials. As the FDA makes clear, “[p]hysicians and other qualified experts (‘clinical investigators’) who conduct these studies are required to comply with applicable statutes and regulations.” Thus, it is not possible to obtain FDA approval without meeting the GCP requirements when a pre-market submission requires clinical data.

What Are the Steps for Establishing an Effective FDA GCP Compliance Program?

There are several steps involved in establishing an effective FDA GCP compliance program. First, entities must work with their counsel to develop custom-tailored compliance policies and procedures. Then, they must implement these policies and procedures in their clinical testing operations. Entities must monitor and document their GCP compliance efforts on an ongoing basis as well, as they must be prepared to affirmatively demonstrate compliance to the FDA when necessary.

Do I Need to Engage a Law Firm for FDA GCP Compliance?

Due to the scope of the FDA’s GCP regulations and the potential risks of noncompliance, all entities that need to comply with the GCP requirements should engage experienced legal counsel. At Oberheiden P.C., we provide FDA GCP compliance to entities nationwide, and we take a client-centric approach focused on helping our clients establish and maintain compliance as cost-effectively as possible.

Schedule a Complimentary Consultation with an FDA Compliance Lawyer or Consultant Today

Do you need to know more about FDA GCP compliance? If so, we invite you to get in touch. To schedule a complimentary consultation with a senior lawyer or consultant at Oberheiden P.C., please call 888-680-1745 or tell us how we can help online today.