FDA Whistleblower Attorney - Federal Lawyer

FDA Whistleblower Attorney

Our Attorneys Help Whistleblowers Report Fraud and Other Violations to the U.S. Food and Drug Administration (FDA)

Lynette Byrd
Attorney Lynette Byrd
FDA Whistleblower Team Lead
Former DOJ Attorneyenvelope iconContact Lynette directly
Tim Allen
Tim Allen
FDA Whistleblower Team
Former Secret Service (Digital Forensics Expert)
Brian Kuester
Attorney Brian Kuester
FDA Whistleblower Team
Former U.S. Attorney and District Attorneyenvelope iconContact Brian directly

The U.S. Food and Drug Administration (FDA) plays an important role in protecting the American public. Through its regulation of food, drug, and cosmetic manufacturers, the FDA helps ensure that the products people buy on a daily basis are safe for their intended use.

But, the FDA’s reach only stretches so far. While the FDA conducts inspections and undertakes other proactive means of enforcement, it relies heavily on voluntary compliance and self-policing. It simply doesn’t have the resources to monitor companies’ testing and manufacturing processes all the time. Of course, while some companies prioritize compliance and transparency, many others do not.

This is where FDA whistleblowers come into play.

Whistleblowers in the private sector are entitled to protection under the Food Drug and Cosmetic Act (FDCA). If you have information about fraud or other violations of the FDCA (or any other statute or regulation that applies to manufacturers), you are entitled to confidentiality and protection against retaliation if you decide to come forward. The same is true for FDA employees who report internal fraud, waste, or abuse under the Whistleblower Protection Act (WPA).

At Oberheiden P.C., we represent FDA whistleblowers nationwide. Whether you work for a private (or publicly traded) company or you work for the FDA, if you have information that the Administration would find useful, we can help you come forward. When you choose our firm to represent you, you will work closely with a senior FDA whistleblower attorney throughout the process, and your attorney will help you make informed and confident decisions every step of the way.

About Our FDA Whistleblower Attorneys and Consultants

Our team of FDA whistleblower lawyers and consultants brings extensive experience to the table. Many of our attorneys worked for the federal government prosecuting FDCA violations and other forms of fraud, waste, and abuse before entering private practice. As a result, not only are they extremely well-versed in the relevant laws and regulations, but they are intimately familiar with the FDA’s enforcement policies and procedures as well.

In addition to working closely with a senior FDA whistleblower attorney, you may also work with our FDA consultants during the course of our representation. Our consulting team includes a former Special Agent in Charge at the FDA as well as a former FDA Director of Compliance. Working with our team, you will feel confident that you know everything you need to know in order to make informed decisions about blowing the whistle.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd
Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester
Brian J. Kuester

Former U.S. Attorney

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney

Local Counsel

John W. Sellers
John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara
Linda Julin McNamara

Federal Appeals Attorney

Aaron L. Wiley
Aaron L. Wiley

Former DOJ attorney

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (DOJ)

Chris Quick
Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow
Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

Blowing the Whistle on Violations of the Food Drug and Cosmetic Act (FDCA)

If you work for a manufacturer or any other company involved in the food, drug, or cosmetics industries, we can help you blow the whistle on violations of the FDCA and other pertinent laws and regulations. The Food Safety Modernization Act (FSMA) prohibits retaliation against employees (and former employees) who blow the whistle on “covered entities.” These entities include:

  • Importers
  • Manufacturers
  • Processors
  • Packing companies
  • Distributors
  • Transportation companies
  • Receiving and holding companies

Our whistleblower lawyers represent employees (and former employees) of all covered entities who need to report all forms of fraud, waste, abuse, and other misconduct. This includes (but is not limited to) statutory violations such as:

  • Failing to meet design or manufacturing requirements
  • Failing to follow Current Good Manufacturing Practice (CGMP) regulations
  • Failing to submit required reports to the FDA
  • Submitting forged, falsified, or inaccurate statements, certificates, or reports
  • Promoting items, medications, or devices without FDA clearance or approval
  • Promoting items, medications, or devices for non-FDA-cleared or non-FDA-approved uses
  • Failing to register or list items, medications, or devices with the FDA
  • Importing items, medications, or devices that do not meet FDA standards
  • Knowingly manufacturing or selling dangerous or defective items, medications, or devices
  • Knowingly deceiving the FDA through any other means

This is just a small sampling of the types of violations that whistleblowers can—and should—report to the FDA. If you believe that you may have information about an FDCA violation or any other form of civil or criminal misconduct, we encourage you to speak with an FDA whistleblower lawyer at Oberheiden P.C. as soon as possible.

Blowing the Whistle on Fraud, Waste, and Abuse Within the FDA

In addition to representing employees in the private sector, we also represent civil servants who need to blow the whistle on fraud, waste, and abuse within the FDA. As stated in a publicly available memorandum to all FDA employees:

“The Whistleblower Protection Act (WPA) of 1989 and the Whistleblower Protection Enhancement Act (WPEA) of 2012 afford employees legal protection to report allegations of official wrongdoing without fear of reprisal. . . . These laws preserve the integrity and high standards of the scientific processes that guide our agency and help to ensure we remain responsible stewards of the public trust . . . .”

Just like whistleblowers in the private sector, whistleblowers within the FDA play a critical role in protecting the American public and preserving public trust in the Administration. Internal whistleblowers are also entitled to protection against retaliation and other reprisals. If you work for the FDA (or previously worked for the FDA) and have information about fraud, waste, abuse of authority, or any other form of misconduct within the Administration, we strongly encourage you to speak with an FDA whistleblower attorney at Oberheiden P.C. about coming forward.

Our Process for Working with FDA Whistleblowers

As a potential FDA whistleblower, it is important to know what you can expect if you decide to come forward with the information you have in your possession. Here is what you can expect when you choose to work with an FDA whistleblower lawyer at Oberheiden P.C.:

  • We Will Keep Your Identity and Information Strictly Confidential – We will not disclose your identity or any information you share with us unless you explicitly authorize us to do so.
  • We Will Help You Make an Informed Decision About Becoming an FDA Whistleblower – We will examine the information you have in your possession and help you make an informed decision about whether to come forward.
  • We Will Communicate with the FDA on Your Behalf – If you decide to come forward, we will communicate with the FDA on your behalf throughout the process. This is true whether you work in the private sector or you work (or used to work) for the FDA.
  • We Will Communicate with You Throughout the Process – We will communicate with you throughout the process as well. We will keep you updated and informed, and your FDA whistleblower attorney will be available when you have questions or concerns.
  • We Will Take All Necessary Legal Action to Protect You – We will take any and all legal action necessary to protect you. While your employer (or former employer) should not attempt to retaliate, if it does, we can protect your legal rights in court.

FAQs: Working with an FDA Whistleblower Attorney to Expose Fraud or Misconduct

How do I become an FDA whistleblower?

The process for filing a whistleblower complaint is different for FDA employees and employees in the private sector. If you believe that you have information about fraud, waste, abuse, or any other form of misconduct involving a regulated entity or the FDA itself, you should speak with an FDA whistleblower attorney about your next steps.

Can I get in trouble for reporting fraud or other violations to the FDA?

You cannot legally get in trouble for reporting fraud or other violations to the FDA. The FSMA prohibits retaliation against employees in the private sector, while the WPA and WPEA protect FDA personnel. Additionally, when you file a whistleblower complaint with the FDA, it is possible to keep your identity confidential. If you face retaliation despite these protections, then your attorney will be able to seek appropriate remedies on your behalf.

How do I report fraud, waste, or abuse as an FDA employee?

Generally, reporting fraud, waste, or abuse as an FDA employee begins with contacting the Office of Special Counsel (OSC). However, before doing so, it is best to consult with an FDA whistleblower attorney to ensure that you will be eligible for protection.

Are FDA whistleblowers protected?

FDA whistleblowers are protected against retaliation in their employment. This includes protection against wrongful termination, demotion, negative performance reviews, and denial of job-related opportunities.

How can an FDA whistleblower attorney help me?

Whether you work for a manufacturer or other company or you work for the FDA, there are lots of ways an FDA whistleblower attorney can help you. Coming forward is important—and, from determining whether you qualify as a whistleblower to working with the FDA or OSC on your behalf, your attorney will be able to assist you every step of the way.


Speak with an FDA Whistleblower Lawyer in Confidence

If you would like to speak with an FDA whistleblower attorney, we encourage you to contact us promptly. To schedule a free and confidential consultation at Oberheiden P.C. as soon as possible, please call 888-680-1745 or tell us how we can reach you online today.

Why Clients Trust Oberheiden P.C.

  • 2,000+ Cases Won
  • Available Nights & Weekends
  • Experienced Trial Attorneys
  • Former Department of Justice Trial Attorney
  • Former Federal Prosecutors, U.S. Attorney’s Office
  • Former Agents from FBI, OIG, DEA
  • Serving Clients Nationwide
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