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How to Select the Top FDA Defense Lawyer

Experienced FDA Defense Team of Attorneys

Jared Davis
Jared H. Davis
FDA Team Consultant
Former FDA and HSI Special Agent in Charge

Do you need legal assistance regarding an FDA investigation or an FDA audit? Are you worried about compliance with FDA laws, regulations, and guidance? If so, then do not wait to get in touch with our team of FDA attorneys and professionals.

The FDA is a federal agency responsible for protecting the public health from dangerous or misleading products. It has the authority to impose corrective actions, enforcement measures, and even criminal penalties for violations of FDA provisions.

Federal experience, knowledge, communication, and passion are key factors that characterize a top defense attorney. Additionally, experience negotiating and settling with the FDA, litigating FDA-related cases, and handling FDA compliance issues are the key factors that comprise a top FDA defense attorney.

At Oberheiden P.C., our team of FDA defense attorneys and professionals are highly experienced in both government and private practice as well as intricate experience negotiating with the FDA and defending our clients.

Let us help you and your company handle the complexities of an FDA action—whether it is a compliance measure, subpoena, audit or inspection, civil enforcement proceeding, or criminal prosecution.

Put Oberheiden P.C. on your side to fight for your reputation and protect your business.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden



Lynette S. Byrd
Lynette S. Byrd

Former Assistant U.S. Attorney


Ellen Comley
Ellen Comley

Senior Counsel


Roger Bach
Roger Bach

Former Special Agent (OIG)

Steven Taylor
Steven Taylor

Healthcare Compliance Consultant

Susan Sage
Susan Sage

Healthcare Auditor

Tips to Select the Best FDA Defense Lawyer

Receiving a subpoena from the FDA, having the FDA conduct an audit of your business, or being involved in a federal investigation can all be worrisome experiences.

Many individuals and companies find it beneficial to hire an FDA defense attorney to communicate with the FDA and handle the investigative issues.

However, how does one choose the best FDA defense attorney? Below we provide five tips for making this decision:

1. Choose an attorney who is not only experienced in FDA negotiations and communications, but also an attorney who is experienced in federal trial procedures.

Your attorney should have ample experience in how the FDA regulates various products such as medical devices, supplements, the food supply chain, biotechnology, prescription drugs, cosmetics, etc.

In addition to the specifics regarding various FDA-regulated products, your attorney should be experienced in handling company marketing activities, pre-approval inspections, labelling and advertising, and FDA investigations, as some initial examples.

The attorney should be sufficiently experienced in FDA-related functions so as to advise their clients on FDA regulation and monitoring in the manufacturing, production, distribution, and marketing stages.

The goal of securing a law firm with attorneys and professionals experienced in FDA defense is to guarantee that you will have the best chance of a favorable end result.

The attorney you consider selecting should also be deeply experienced in federal practice, including but not limited to the federal subpoena power, trial practices, and the federal rules of civil procedure.

This will give you the peace of mind that your attorney can aptly negotiate with federal agencies on your behalf and successfully navigate the federal process.

2. Make sure your attorney has a solid grasp of the relevant laws, regulations, and guidance under the authority of the FDA.

It is critical that you select an attorney who is knowledgeable of the relevant FDA laws, regulations, and guidance.

Laws relevant to the FDA are complex and in a constant state of fluctuation. Their interpretation and application demand a team of knowledgeable attorneys and professionals who are intricately familiar with the foundations, specifics, and exceptions to statutory provisions affecting companies dealing with FDA-regulated products.

For instance, the Food, Drug, and Cosmetic Act (“FDCA”) is a critical law enforced by the FDA. Your attorney should have a clear understanding of this law, how it is enforced, the tools used by the FDA to regulate and enforce its provisions, and liability under this law.

Having a robust knowledge of FDA laws will allow your attorney to deliver advice that clearly aligns with your company’s objectives and enables it to prepare for the future and be protected against the FDA’s regulatory and enforcement authority.

It will also help ensure that your attorney can accurately counsel you on the applicability of these federal laws to your case as well as the evolving nature of such laws.

And with accurate counselling services come dedicated advocacy and skilful representation.

3. Research your attorney and their law firm, particularly their track record of successful FDA-related cases, settlements, litigations, and other enforcement measures.

Attorneys and law firms everywhere boast of their experience and education. While these are critical factors, an equally important factor—and sometimes more important factor—is the success record of the attorney and law firm.

Law firms will often post on their website example cases that they have handled and the results they obtained. This can be helpful as individuals contemplate choosing the best FDA defense attorney.

A proven success record reflects experience, knowledge in federal laws pertaining to FDA enforcement, and consistency.

Overall, you should focus on retaining an attorney who is motivated to fight for their clients and save them time, money, and stress.

4. Try to choose an attorney whose work ethic and character reflect an overall dedication and passion to success.

It is important to choose an attorney that demonstrates an attitude of dedication and passion to success. A dedicated attorney is committed to fighting for their clients and defending them against FDA-related investigations or other enforcement proceedings.

A passionate attorney will fight aggressively to secure the best negotiation settlement or litigation outcome on behalf of their clients.

These two factors are critical when deciding how to choose the best FDA defense attorney. Dedication and passion demonstrate that your attorney will be more likely to go the extra mile or try innovative arguments in order to successfully represent and advise their clients.

Many individuals can ascertain the dedication and passion of an attorney by speaking with them. Oftentimes attorneys will offer clients a free initial consultation. Use this free consultation as a means to gauge the character of the attorney.

Do not be afraid to ask questions to the attorney whether it is regarding their experience, knowledge of the FDA, or other matters that can help you reach an informed decision about whether or not to hire them.

5. Ensure that your attorney has a standard practice of maintaining open and continuous communication with its clients.

Every law firm should strive to achieve a healthy policy of open communication with its clients regarding the plan of attack, expected outcome, fees, defense strategy, steps for compliance improvement, etc.

However, law firms often delegate duties to junior staff or research assistants and only communicate critical matters to clients. Such a strategy of periodic updates and intermittent communication is disadvantageous to clients.

Retaining an attorney who is personally involved in every stage of the FDA-related investigation, audit, or other enforcement proceeding creates a positive impact for individuals.

This enables clients to stay informed of the major decisions of their attorney and also allows them to feel comfortable asking questions and confiding in their attorney.

How Oberheiden P.C. Can Help You

At Oberheiden P.C., our team of FDA defense attorneys and professionals can help you negotiate and communicate with the FDA.

We have extensive federal government experience as well as private practice experience. This gives our team a unique inter-disciplinary perspective that allows us to best serve our clients and defend them against FDA investigations, audits, or other enforcement proceedings.

Our attorneys and professionals are highly experienced in navigating FDA investigations and other proceedings, including advising our clients on the strength of their compliance policies.

Some of the FDA-related matters we assist our clients with include the following:

  • Company product development;
  • Company compliance with its production and manufacturing processes;
  • Company compliance with its internal operations;
  • Trial studies;
  • Marketing development;
  • Pre-marketing approval for new products;
  • Product labelling, advertising, marketing, and other promotional strategies;
  • Drafting commercial agreements;
  • FDA enforcement actions and criminal prosecutions; and
  • Dealing with product recalls

If you have a question about one of the above matters or an additional matter, give us a call as soon as possible. A successful defense requires a prompt response.

Need Advice with FDA Defense?

Being investigated or audited by the FDA can be a stressful time, especially considering the penalties, reputational harm, and impact on your company’s future.

A disciplinary proceeding, subpoena, negative audit report, or especially a civil or criminal investigation can wreak havoc on your entire business.

Do not let this happen to you and your company without doing everything you can to protect your rights. Retain an attorney experienced in FDA-related matters as soon as possible.

At Oberheiden P.C., our team of FDA defense attorneys and professionals are committed to defending its clients against FDA-related investigations and other enforcement measures.

We can offer you a personalized defense strategy, dedicated team of attorneys and professionals, and continuous communication to allow you to make informed decisions.

Our FDA defense attorneys and professionals will fight aggressively to protect your data, research, clinical trials, and business’ hard work against an FDA investigation.

If you need assistance regarding an issue under the FDA’s authority, call or contact us today for a free consultation and ask to speak with one of our FDA defense attorneys.

Further Information About FDA Defense

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