FDA Compliance

Is your business FDA-compliant? The U.S. Food and Drug Administration (FDA) has broad oversight and enforcement authority, and companies that fail to maintain compliance can face steep penalties. Our federal compliance lawyers represent food, drug, medical device, medical testing, and other companies nationwide.

Dealing with the U.S. Food and Drug Administration (FDA) is a fact of doing business for companies in a variety of different industries. From securing approvals to undergoing inspections and managing recalls, there are numerous aspects to FDA compliance, and all companies need to have not only a clear understanding of their obligations, but also a clear strategy for meeting these obligations effectively.

Our firm serves as FDA compliance counsel to companies nationwide. We represent companies that manufacture and sell products and services in all sectors falling within the FDA’s jurisdiction, including prescription and over-the-counter (OTC) medications, biologics, medical devices, medical tests, medical software, foods, food additives, dietary supplements, and cosmetics. Several of our lawyers have particular experience with healthcare-related products and services such as cannabidiol (CBD) products, genetic cancer screenings, and compounded medications, and all of our lawyers, investigators, and consultants are deeply knowledgeable about the FDA’s rules, regulations, and investigative practices.

Comprehensive FDA Compliance Services: Don’t Let Oversights Put Your Company at Risk

As with all other aspects of corporate compliance, FDA compliance requires a nuanced and detail-oriented approach. In order to develop an effective FDA compliance program, it is essential to have not only a clear understanding of the Food, Drug, and Cosmetic Act (FDCA) and other laws and regulations that fall within the FDA’s jurisdiction, but also a clear understanding of your company’s products, services, and business practices that raise FDA compliance implications.

When we represent a client with regard to FDA compliance, our lawyers, investigators, and consultants

work closely with the company’s executives, in-house attorneys, subject-matter experts, and other key personnel to assess the company’s gaps and risks. Once we have a clear picture of the company’s needs, then we begin the process of helping our client achieve full compliance efficiently and without wasting company resources. By taking this approach, we are able to provide comprehensive and cost-effective compliance representation at a fraction of the cost charged by most other law firms.

What Does Your Company Need in Order to Avoid Unwanted FDA Scrutiny?

Whether you have questions about a particular compliance issue or you need to build a complete FDA compliance program from scratch, our team is prepared to guide you with sound advice based on real-world experience. Our FDA compliance services include:

FDA Compliance Counseling

We advise clients daily on a host of compliance issues. Whether you are operating under a compliance program developed by our firm or you have prior FDA compliance counsel, we can provide you with prompt, insightful, and actionable advice when you need it. As a result of our attorneys’ extensive experience in the field, we are able to quickly answer many questions that would require hours of research at other law firms.

Compliance Program Development and Implementation

For companies that need to develop comprehensive FDA compliance programs from scratch or revamp their outdated or ineffective compliance efforts, we provide full-service representation from strategizing and planning through documentation and implem

entation. Our FDA compliance programs are fully custom-tailored, and they are designed to ensure not only that our clients’ businesses are compliant, but that they will be able to efficiently demonstrate their compliance in the event of an FDA audit or investigation. We assist clients with:

  • Development of FDA-specific policies and procedures
  • Incorporation of FDA-specific terms into employee codes of conduct and other existing company documentation
  • Workflow and process management to ensure FDA-related issues are timely addressed at all stages of product development, commercialization, and distribution
  • Employee training tailored to individual roles within the company
  • Compliance program implementation and testing, and fine-tuning of relevant processes and procedures
  • Ongoing documentation of FDA compliance efforts and practices

Sampling, Licensing, and Distribution

Sampling, licensing, and distribution are three areas in particular where even the most well-intentioned companies can get into trouble. Our compliance lawyers can advise you regarding the legal implications involved and the steps required in order to conduct sampling and to license and distribute your company’s products without running afoul of the FDA’s requirements.

Marketing and Scientific Claims

When taking a product to market, securing FDA approval is not the end of the story with regard to the agency’s oversight. The marketing of FDA-approved products is a common problem area for companies as well—specifically, complying with the limitations on scientific claims. In order to make any scientific claim (or even arguably scientific claim) about a product’s effectiveness, benefits, or comparative features, it is necessary to have adequate substantiation. The FDA routinely initiates enforcement actions against companies which it believes have not adequately substantiated their scientific claims about their products.

Adverse Event Response and FDA Notification

When an adverse event occurs, an effective response is required. We assist clients with all aspects of adverse event response, from conducting attorney-client-privileged risk assessments to communicating with the FDA. With several former federal prosecutors and Special Agents on our team, we have a first-hand understanding of how the FDA, the Federal Bureau of Investigation (FBI), the U.S. Department of Justice (DOJ), and other federal agencies handle these types of scenarios, and we can use our insights to help you make informed and strategic decisions that protect your company’s bottom line.

Monitoring, Auditing, and Enforcement

Companies must continuously monitor their FDA compliance efforts, and they must periodically conduct internal audits in order to reassess their compliance needs. Our lawyers, investigators, and consultants can conduct these efforts independently or working in conjunction with your in-house counsel, and we can advise you regarding enforcement and employee discipline as and when necessary.

Ongoing Compliance Updates and Modifications

The FDA regularly updates its compliance policies; and, as a result, FDA compliance is a moving target. Our attorneys constantly remain up-to-date on the latest developments in FDA compliance, and we can proactively notify you when changes to your company’s policies or procedures are required. Despite the fact that updates are issued so regularly, the FDA does not provide any lenience for companies that fall behind. We can make sure that you are not blindsided by a compliance obligation of which you were entirely unaware.

Beyond the FDA: Additional Compliance Concerns for Companies Subject to FDA Oversight

Companies that are subject to oversight by the FDA will generally be subject to the oversight of multiple other federal agencies as well. Additionally, companies that do not manufacture or distribute medications, medical devices, dietary supplements, or other products that are subject to FDA approval can still face FDA scrutiny under a variety of different circumstances. Whether as a result of a contractual relationship or as a result of selling a third-party product or service, all types of companies and healthcare providers can face a host of federal compliance obligations, and our attorneys’ and consultants’ past government experience gives us unique insight into this complex area of corporate com

pliance.

Beyond product approvals, substantiation of marketing claims, adverse event reporting, and other FDA-specific compliance issues, we also routinely advise our clients with regard to matters such as:

  • Healthcare fraud compliance (including Anti-Kickback and Stark Law compliance in relation to the sale of FDA-regulated medications and medical devices)
  • Antitrust compliance (in relation to third-party agreements that raise questions about market splitting, competitive restrictions, and other practices that are harmful to consumers)
  • Federal Trade Commission (FTC) compliance (in relation to false marketing claims and allegations of deceptive consumer advertising)
  • Securities and Exchange Commission (SEC) compliance (in relation to publishing false or misleading about FDA approvals, clinical trial results, and other matters that have the potential to influence investment decisions)
  • Data privacy and security (companies that store study participants and customers’ personally identifying information (PII) and that collect website visitors’ information online are subject to myriad state, federal, and international data privacy and security requirements)
  • FBI and DOJ investigations (when compliance issues lead to federal investigations, these agencies will often assist in FDA inquiries)

From negotiating agreements for the licensing and distribution of FDA-approved products to preparing and submitting regulatory filings, our attorneys can do everything necessary in order to protect your company against undue exposure to FDA and other federal agency inquiries. With shortcomings having the potential to trigger civil enforcement action and potentially even criminal prosecution, companies and their leaders must make federal compliance a top priority. This starts with hiring experienced legal representation; and, at Oberheiden, P.C., we are fully prepared to take responsibility for guiding you and your company to safety.

Speak with an FDA Compliance Lawyer at Oberheiden, P.C.

What does your company need to do in order to be FDA compliant? What other compliance obligations does your company have? Are your current compliance efforts coming up short, and could you be exposed in the event of a federal investigation? To learn the answers to all of these questions and more, call 888-680-1745 or request a complimentary consultation online today.

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