FDA Whistleblower Attorney (November Update)
Our Attorneys Help Whistleblowers Report Fraud and Other Violations to the U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) plays an important role in protecting the American public. Through its regulation of food, pharmaceutical, 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 false claims 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 false claims, 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 on pharmaceutical violations.
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)
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, pharmaceutical, 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 pharmaceutical 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 program 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 pharmaceutical 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 false claims or other violations to the FDA?
You cannot legally get in trouble for reporting false claims act 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 false claims, waste, or abuse as an FDA employee?
Generally, reporting false claims, 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.
Schedule a Free and Confidential Consultation with an Attorney at Oberheiden P.C.
Pharmaceutical industry whistleblowers play a critical role in exposing fraudulent practices by drug companies, pharmacies, and medical device manufacturers, especially when misconduct affects Medicare and Medicaid programs or violates FDA regulations. Many cases involve fraudulent behavior tied to government contracts, improper marketing, billing schemes, or safety-related violations that put patients at risk. By coming forward, whistleblowers gain access to strong legal protections, and an experienced attorney can help them document wrongdoing, preserve anonymity, and pursue compensatory damages when permitted under federal law. At Oberheiden P.C., individuals can receive a free consultation to understand their rights and decide whether to report misconduct safely and effectively.
Whistleblowers are often the first to detect issues such as unlawful promotion, manipulated clinical data, kickbacks, or medical device irregularities, all of which constitute serious forms of healthcare fraud. Whether a company is bypassing FDA requirements, abusing Medicare and Medicaid programs, or violating compliance standards tied to government contracts, reporting the misconduct helps protect patients and taxpayers. An attorney can help assess evidence, submit protected disclosures, and guide clients through the federal process to ensure they receive all available whistleblower benefits. With proper guidance, individuals can expose corruption within drug companies while safeguarding their careers and contributing to accountability within the healthcare system.
If you have questions about blowing the whistle against a pharmaceutical company, pharmacy, or PBM, we encourage you to contact us promptly. We will arrange for you to speak with an attorney in complete confidence as soon as possible. To schedule a free, no-obligation consultation with a pharmaceutical whistleblower attorney at Oberheiden P.C., please call 888-680-1745 or tell us how we can reach you online
