FDA Biologics Compliance
Experienced FDA Compliance Counsel for Biologics Researchers and Manufacturers in the U.S. and Abroad
FDA Biologics Compliance Team Lead
FDA Biologics Compliance Team Lead
Former DOJ Attorney
FDA Biologics Compliance Team Lead
Former Senior DOJ Trial Attorney
The U.S. Food and Drug Administration (FDA) is the primary federal agency responsible for overseeing biologics research in the United States as well as the sale of biological products manufactured in the U.S. and abroad. Like all areas of FDA compliance, effectively managing biologics compliance is a complex, time-intensive, and resource-intensive process, and both domestic and international organizations must ensure that they are doing everything necessary not only to maintain compliance—but also to demonstrate compliance to the FDA when necessary.
At Oberheiden P.C., the lawyers and consultants on our FDA compliance team rely on extensive experience in both the public and private sectors. Our team includes not only lawyers who have devoted their careers to helping organizations manage federal compliance, but also former federal prosecutors and FDA personnel. As a result, we have an in-depth understanding of what it takes to effectively manage FDA biologics compliance, and we rely on this understanding to provide comprehensive, efficient, and forward-thinking advice to our clients.
How the FDA Regulates Biologics Research and Manufacturing in the U.S. and Abroad
The FDA regulates all aspects of biologics research and manufacturing, as well as the marketing and distribution of biological products to healthcare providers, pharmacies, and consumers. In doing so, it not only imposes regulatory obligations with which organizations are expected to proactively comply, but also conducts inspections, post-market surveillance, and other enforcement activities.
Pre-market and post-market approvals are a significant part of FDA biologics compliance as well. When FDA approval is required, companies and other organizations must ensure that they are prepared to demonstrate full compliance with all pertinent laws, rules, and regulations. We assist our clients with all aspects of FDA compliance, from securing FDA approval and managing compliance programs to responding to inspections and other inquiries.
While biologics researchers, manufacturers, and other companies in the industry must comply with the federal Food, Drug, and Cosmetic Act (FD&C Act) and the other statutes and regulations that the FDA enforces generally, in many cases they must adhere to industry-specific guidance as well. For example, the FDA has issued specific guidance for biologics and biologics-related research and commercial activities including:
- Allergenics
- Blood
- Cellular and gene therapy
- Tissue
- Vaccines and related biological products
- Xenotransplantation
- Combination biological products
- Clinical trials
- Importing and exporting biologics
Our lawyers and consultants guide our clients step-by-step through the FDA biologics compliance process. We begin by working with our clients to gain an in-depth understanding of their operations, which allows our lawyers to comprehensively identify the specific laws, rules, and regulations that apply. Then, we work with our clients to develop custom-tailored policies and procedures that they can implement efficiently in order to consistently and effectively manage FDA compliance. Our lawyers also communicate with the FDA on behalf of our clients, and draft all applications, requests, responses, and other forms of correspondence necessary for our clients to conduct their operations with confidence.
Our FDA Biologics Compliance Services
We work with new and existing companies and research organizations both in the U.S. and abroad to help them effectively manage all aspects of FDA compliance. Our FDA biologics compliance services include:
Developing and Implementing FDA Compliance Policies and Procedures
All companies and research organizations involved with biologics need to develop and implement custom-tailored FDA compliance policies and procedures. By working closely with our clients to outline their specific risks and needs, we are able to develop targeted compliance strategies that comprehensively meet our clients’ needs without subjecting them to undue compliance burdens. Custom-tailored policies and procedures are the foundation of any FDA compliance program; and, not only can they help organizations avoid FDA scrutiny, but they can also help organizations withstand scrutiny when necessary.
Submitting FDA Biologic License and Approval Applications
A significant portion of our FDA biologics compliance practice involves assisting clients with the submission of FDA license and approval applications. Along with submitting pre-market and post-market approval applications for biologics, this includes submitting applications for medical devices licensed as biological products. We take a detail-oriented and compliance-first approach to managing the licensing and application processes that is designed to help our clients secure the FDA’s authorization as quickly and cost-effectively as possible.
Preparing for Pre-License and Pre-Approval Inspections
Inspections are a critical step in the licensing and approval processes for biologics companies and research organizations. We help our clients thoroughly prepare for their FDA inspections, systematically evaluating their compliance efforts and conducting mock inspections in order to proactively identify any issues that might otherwise come up during the FDA’s examination of their facilities. This is one stage in particular where a proactive approach can save significant time and resources in the future, as unfavorable inspection results can significantly delay the licensing and approval processes.
Managing Post-Market Approvals and Compliance
While securing pre-market approval is a critical step toward monetizing biologics innovations, developments, and products, it is ultimately just one step of many. Biologics manufacturers, distributors, and other companies must proactively manage their post-market approval and compliance obligations as well. At Oberheiden P.C., we continue to work closely with our clients on an ongoing basis to help them take all of the steps necessary to avoid triggering unwanted (and potentially costly) scrutiny from the FDA.
Corresponding with the FDA’s Center for Biologics Evaluation and Research (CBER)
We also handle correspondence with the FDA’s Center for Biologics Evaluation and Research (CBER) on behalf of our clients, including correspondence with the CBER’s Office of Compliance and Biologics Quality (OCBQ). The CBER and OCBQ conduct inspection, surveillance, and compliance activities focused specifically on the biologics industry. Our lawyers are available to assist our clients as needed with all CBER and OCBQ matters, including (but not limited to) submitting Biological Product Deviations Reports (BPDRs) and managing compliance-related inquiries.
Managing Adverse Events, Recalls, Market Withdrawals, and Safety Alerts
Our lawyers are also available to assist our clients on an as-needed basis with matters such as adverse events, recalls, market withdrawals, and FDA Safety Alerts concerning their biological products subject to FDA oversight and regulations. When issues arise, not only can companies and other organizations face potentially significant enforcement-related risks, but they can potentially face liability exposure in civil litigation as well. By working quickly to help our clients make informed decisions and manage all communications with the FDA on their behalf, we can often significantly mitigate our clients’ risk while also helping to put them in a stronger position for the future.
Put our highly experienced team on your side
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: Managing FDA Biologics Compliance in Today’s Regulatory Environment
When Are Biologics Subject to FDA Pre-Market Approval?
Pre-market approval is required for most biologics intended for distribution and sale in the United States, including medical devices licensed as biological products. Depending on the nature of a biologic or biological product, there may be various paths toward securing FDA clearance or approval. Our lawyers and consultants can help you determine what is necessary and how best to approach the pre-market approval process.
What Are the Risks of FDA Non-Compliance for Biologics Companies in the U.S. and Abroad?
Failure to comply with any laws, rules, or regulations governing biologics manufactured and sold in the United States can have consequences ranging from denial of approval or licensure (or revocation of approval or licensure) to civil monetary penalties, and even criminal prosecution in some cases. As a result, all biologics companies need to prioritize FDA compliance, and at Oberheiden P.C. we work closely with our clients to help ensure they are doing everything that is necessary.
What Does it Take for Biologics Companies and Research Organizations to Effectively Manage FDA Compliance?
For biologics companies and research organizations, effectively managing FDA compliance is a substantial undertaking. Companies and organizations must first identify all relevant laws, rules, and regulations, and then they must address each of these sources of authority as it applies to their specific operations. When it comes to FDA compliance, a custom-tailored approach is key—as, when conducting inspections, the FDA expects to see that companies and organizations are devoting sufficient time, effort, and resources to ensuring their biological products are safe for their intended use.
What Are the Five Key Aspects of FDA Biologics Compliance?
It is difficult to narrow down FDA biologics compliance to five key areas—simply because this area of compliance is so complicated. But, if we look at the major steps in the process of bringing biological products to market, we can identify five key areas of FDA biologics compliance as: (i) pre-market licensing and approval; (ii) FDA (and CBER and OCBQ) inspections; (iii) post-market licensing and approval; (iv) internal compliance monitoring and enforcement; and (v) reporting and FDA enforcement response.
How Can Companies in the U.S. and Abroad Clearly Establish FDA Biologics Compliance?
Clearly establishing FDA biologics compliance and mitigating the risks of facing FDA scrutiny involves taking a proactive approach to compliance management. At Oberheiden P.C., we work with our biologics clients to ensure that they have the policies, procedures, protocols, systems, and organizational structure needed to successfully withstand scrutiny from the FDA.
Speak with an FDA Biologics Compliance Lawyer or Consultant at Oberheiden P.C.
If you would like to know more about how we help biologics companies and research organizations manage FDA compliance, we invite you to get in touch. Please call 888-680-1745 or contact us online to schedule a complimentary initial consultation at Oberheiden P.C.
